| 22 Mar 2018 | BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI: 50382903678568); 8. 367861 (UDI:… | Becton Dickinson & Company | Device | Class I | 4 |
| 19 Mar 2018 | Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 16 Mar 2018 | Roasted Pumpkin Seeds, packaged in 1 lbs. poly film bags with a twist type closure or in a re-sealable pouch, labeled as "distributed by Oregon Food Bank". Product was also distributed in packages labeled as Kale Joy brand. (79564) | Oregon Food Bank | Food | Class II | 1 |
| 12 Mar 2018 | Name: Trader Joe s Chocolate Chip Cookies SKU 68075 Net Weight: 12 oz. (340g) Number of units per package: 16 cookies Package type: Kraft paper bag (79527) | Food and Beverage Inc. | Food | Class II | 1 |
| 10 Mar 2018 | 100% WHOLE WHEAT BREAD DOUGH, SKU: 11895, Frozen | Maplehurst Bakeries, LLC. | Food | Class II | 3 |
| 9 Mar 2018 | Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60. | Akorn, Inc. | Drug | Class III | 1 |
| 9 Mar 2018 | Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4. (79450) | Alva-Amco Pharmacal Companies., Inc. | Drug | Class III | 1 |
| 9 Mar 2018 | NXTGEN Botanicals, Maeng Da Kratom, Dietary Supplement, 70 Capsules, Made in the U.S.A (79477) | Individual firm, name withheld | Food | Class I | 1 |
| 9 Mar 2018 | Chia Seeds packaged in poly film bags as both a twist type closure and a re-sealable pouch, net wt. 1 lb. (79502) | Oregon Food Bank | Food | Class II | 1 |
| 9 Mar 2018 | RED Vein Kratom POWDER, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The powder is packaged in plastic heat sealed pouches. Each package sold in 28 grams (1 ounce), 56 grams (2 ounces), and 112 grams (4 ounces). The varieties under each brand include: -Maeng Da Thai Kratom Powder (Horn… | Individual firm, name withheld | Food | Class I | 6 |
| 8 Mar 2018 | Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90 (79472) | Individual firm, name withheld | Drug | Class III | 1 |
| 7 Mar 2018 | Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3 | American Pharmaceutical Ingredients LLC | Drug | Class II | 2 |
| 6 Mar 2018 | La Marinera, Dried Yellow Potatoes-Papa seca amarilla, NET WEIGHT 10oz (283.5gr.), Imported/Distributed by: Guixens Food Group, Inc., Expiration date: July 2018 (79519) | Guixens Food Group, Inc. | Food | Class I | 1 |
| 6 Mar 2018 | Cardamom Pods Green Whole Organic Sold in 25 lb. bulk boxes and 1 lb. retail plastic bags UPC 1 pound bags: 7-6796302528-9; UPC bulk: 7 679630257-2 Imported from Guatemala Starwest Botanicals, Sacramento, CA | Starwest Botanicals, Inc | Food | Class I | 1 |
| 6 Mar 2018 | Almond Love Bar - Vegan Chocolate Bar, wrapped in plastic wrap with label on top. 2.5 oz bar. UPC 0 91037 32678 2 The product is read in parts: "***almond love bar***2.5oz***Eatin' Alive***PLANT BASED NOSH***Keep Refrigerated***Ingredients: Crust (Almond, Coconut Oil, Cacao, Coconut Sugar, Salt), Almond Butter… | Individual firm, name withheld | Food | Class II | 2 |
| 5 Mar 2018 | Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038 | Novel Laboratories, Inc. | Drug | Class III | 1 |
| 5 Mar 2018 | Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01 | Pine Pharmaceuticals, LLC | Drug | Class III | 1 |
| 5 Mar 2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05. | Sagent Pharmaceuticals Inc | Drug | Class II | 3 |
| 5 Mar 2018 | 9 inch Asparagus and Goat Cheese Quiche, packaged in a cardboard box with a clear window. UPC # 2 52209 10599 8. The retail label is read in parts: "***ASPARAGUS GOAT CHEESE QUICHE ***NEW SEASONS MARKET***Egg, whole milk, fresh goat cheese, sour cream (milk, cream, nonfat dry milk, enzyme), asparagus, salt, pie shell… | New Seasons Market LLC | Food | Class II | 1 |
| 5 Mar 2018 | Kodiak Cakes, Energy Waffles, Blueberry Chia, Net Wt 10.72 Oz (304 g), Kodiak Cakes, Park City, UT. Packaging configuration: 8-ct chipboard carton (selling unit); 8 cartons per shipping case (79415) | Kodiak Cakes, LLC | Food | Class II | 1 |
| 2 Mar 2018 | ripple Chocolate Nutritious Pea Milk; 48 oz. plastic bottle; 8 g Plant Based Protein 30% Less Sugar than Chocolate Milk; 50% More Calcium than Milk 32 mg DHA Omega 3's UPC: 8 55643 00607 6 Distributed by Ripple Foods, Emeryville, CA (79448) | RIPPLE FOODS PBC | Food | Class II | 1 |
| 1 Mar 2018 | Food Club, Essential Choice, Puffed Rice, Net Wt 6 Oz (170 g), UPC 36800 31852 | Gilster-Mary Lee Corp. | Food | Class II | 1 |
| 1 Mar 2018 | Dried Beef Party Rye Dip; Ingredients: Hellman's Mayonaise, Sour Cream, Dried Beef (Cured with Water, Salt, Sugar, Sodium Nitrate, Sodium Nitrite), Parsley, Onion, Dill Weed; SELL BY date up to 3/11/18 | WEIS MARKETS | Food | Class I | 1 |
| 28 Feb 2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10 | Osmotica Pharmaceutical Corp | Drug | Class III | 1 |
| 28 Feb 2018 | Adams Reserve, Fajita Grilling Rub 5.7 oz. Bottle Item Code: 04544, 12 bottles per case | Adams Extract & Spice LLC | Food | Class II | 1 |
| 28 Feb 2018 | Tank Truck #1 Sugar Syrup (403763) | ASR GROUP INTERNATIONAL INC | Food | Class II | 3 |
| 28 Feb 2018 | All-Natural Ciolo Nut-Free Basil Pesto, 7 oz., plastic container, Item #: 30019.18 (79432) | Blue Moose of Boulder, LLC | Food | Class I | 1 |
| 27 Feb 2018 | Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients. (79386) | Iridex Corporation | Device | Class II | 1 |
| 27 Feb 2018 | Seviroli brand Cannoli Shells. Large Plain 36 ct., and Small Plain 72 ct. (79372) | Ariola Foods, Inc. | Food | Class II | 1 |
| 27 Feb 2018 | Clay Mask Kit; 2 glass jars of clay: Green Tea Clay 0.3 oz., and French Rose Clay 0.4 oz. 1 fan mask brush; and 1 terra cotta mixing bowl. Ingredients: Green tea clay, Green (Montmorillonite) clay, Organic Green Tea (Camellia Sinensis) French Rose Clay, Rose Clay (Kaolin Clay) Rhassonl Clay (Moroccan Lava Clay.… | Plant Devas Inc | Food | Class II | 8 |
| 26 Feb 2018 | RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10 | Mckesson Packaging Services | Drug | Class II | 1 |
| 23 Feb 2018 | CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing. | Medical Components, Inc dba MedComp | Device | Class II | 10 |
| 23 Feb 2018 | Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636. | Bayer HealthCare Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 23 Feb 2018 | Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC 0310-0657-58 | AstraZeneca Pharmaceuticals LP | Drug | Class III | 1 |
| 23 Feb 2018 | Life Change Fat Burner, 90 Gel Caps!, Burn Fat!, Remove fat from the liver! 1000mg; 2 capsules daily (79332) | Get The Tea | Food | Class II | 1 |
| 23 Feb 2018 | Key Lime Pie Handcrafted All-Natural Pop; Net Wt. 3.2 OZ (90g) (79351) | King of Pops | Food | Class II | 1 |
| 23 Feb 2018 | NuChef Soy Sauce, Contenido Neto: Un Gal¿n (128 fl. oz), Packed for Northwestern Selecta | Gasco Industrial, Corp. | Food | Class II | 2 |
| 23 Feb 2018 | Testosterzone 180 count bottle packaged in an amber plastic bottle with a black cap | Progressive Laboratories, Inc | Food | Class I | 4 |
| 22 Feb 2018 | labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028 | SCA Pharmaceuticals, LLC. | Drug | Class III | 1 |
| 22 Feb 2018 | Pink flexible, plastic package: Godis Paskkyckling Marshmallow Candy; IKEA; Net Wt. 3.5 oz.; date codes: 10/23/2018 - 01/26/2019; Produced in Sweden for: by IKEA Food Services AB, Almhultsgatan 2, SE-125 86 Malmo, Sweden. Best Before: 10/23/2018 thru 01/26/2019. | Ikea North America Srvcs Inc | Food | Class III | 1 |
| 21 Feb 2018 | Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05 | Akorn, Inc. | Drug | Class III | 1 |
| 21 Feb 2018 | Emerald brand Glazed Walnuts; Net WT. 6.5 OZ; Re-sealable pouch | Snyder's-Lance Inc. | Food | Class II | 1 |
| 21 Feb 2018 | HEINEN'S Potato Gnocchi * Preservative Free * 9 oz. (225 g) in clear film plastic trays (79322) | La Pasta, Inc. | Food | Class I | 1 |
| 21 Feb 2018 | Whole Foods Vegan Buffalo Chicken Bites; Net Wt. 9 oz; Expiration Date: 2/27/2018; UPC: 636910500059 (79299) | Sunneen Health Foods, LLC | Food | Class I | 1 |
| 20 Feb 2018 | IMRIS ORT100 Table, Part Number 110470-000 | Deerfield Imaging, Inc. | Device | Class II | 2 |
| 20 Feb 2018 | Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25. | Hospira Inc. A Pfizer Company | Drug | Class II | 1 |
| 20 Feb 2018 | Buttermilk Pancake and Waffle Mix, Item number: 6170B25, packaged in 25 lbs. bulk kraft bag. The label is read in parts: "***BUTTERMILK PANCAKE & WAFFLE MIX***Net Wt 25 LB *** INGREDIENTS: Organic Whole Grain Buckwheat Flour, Organic Stone Ground Whole Wheat Pastry Flour, Wheat Gluten, Cane Sugar, Baking Powder… | Bob's Red Mill Natural Foods, Inc. | Food | Class III | 1 |
| 20 Feb 2018 | Cosmic Crunch Granola, packaged in paper bag, net wt 10 oz. The product is labeled in parts: "***COSMIC CRUNCH superfood granola***10oz***Margalaxy***Ingredients: Walnuts, Almonds, Maple Syrup, Maca Powder, Flax meal, Cinnamon, Sea Salt, Vanilla, Coconut Oil, Chia Seeds, Goji Berries***Contains: Walnuts & Almonds***". (79325) | Margalaxy LLC | Food | Class II | 1 |
| 20 Feb 2018 | Lotte Kancho Choco-Biscuit; Sold as Lotte Kancho - 42 g -1.48 oz. UPC CODE: 8801062 144815; Lotte Kancho Cup - 95 g cup - UPC CODE: 8801062 516858; Lotte Kancho Multi - 168 g - UPC CODE: 8801062 144815. Master carton UPC: 1 8801062 133090 Ingredients: Wheat Flour, Sugar, Blended oil (hydrogenated palm oil, Palm oil,… (79312) | Lotte International America Corp. | Food | Class I | 1 |
| 20 Feb 2018 | Sezam Kale Salad ingredient kits, net wt. 6.43 pound. Ingredients are packaged individually and then placed in one large bag. The ingredients from the kit was mixed and sold in deli cases at retail stores. The product sold in deli cases has the UPC 2 11565 20216 1. | Market of Choice Inc | Food | Class I | 1 |
| 19 Feb 2018 | Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05 (79304) | Kalchem International, Inc. | Drug | Class II | 1 |
| 16 Feb 2018 | 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00. | B. Braun Medical Inc | Drug | Class II | 1 |
| 16 Feb 2018 | Cherry SKI LEMON ORANGE AUTHENTIC CITRUS SODA 12 oz can CONTAINS: CARBONATED WATER, HIGH FRUCTOSE CORN SYRUP, LEMON JUICE CONCENTRATE, ORANGE JUICE CONCENTRATE, CITRIC ACID, NATURAL FLAVOR, SODIUM BENZOATE (PRESERVATIVE), CAFFEINE, CELLULOSE GUM, RED #4, GUM ARABIC, BLUE #1. UPC: 0 71644 20103 0 (79256) | Double-Cola Co.-USA dba The Double Cola Company | Food | Class II | 1 |
| 16 Feb 2018 | M&P Food Productions brand Vareniki, Potato and Mushroom, Net Wt. 14 oz. (396 g), Keep Frozen, UPC: 7 07163 02617 4 | M & P Food Productions, Ltd. | Food | Class II | 7 |
| 15 Feb 2018 | PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04 | Medline Industries Inc | Drug | Class II | 1 |
| 15 Feb 2018 | Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25. | Apollo Care | Drug | Class II | 2 |
| 15 Feb 2018 | Seggiano Artichoke & Garlic Sauce & Spread Net Weight 200g, 7.1 oz, packaged in Glass jar, UPC Code: 812603020381 (79320) | Seggiano Usa Inc. | Food | Class I | 1 |
| 14 Feb 2018 | ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is… | Brainlab AG | Device | Class II | 1 |
| 14 Feb 2018 | Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01 | LEADIANT BIOSCIENCES, INC | Drug | Class III | 1 |
| 14 Feb 2018 | SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120 | Fagron, Inc | Drug | Class II | 1 |
| 14 Feb 2018 | Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015 (79327) | Bella All Natural | Drug | Class I | 1 |
| 14 Feb 2018 | Springside Monterey Jack Garden Vegetable Cheese, 40 lbs. | Springside Cheese Corp | Food | Class III | 12 |
| 13 Feb 2018 | ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239 | Tosoh Bioscience Inc | Device | Class II | 2 |
| 13 Feb 2018 | RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET¿ RF is intended for the… | Stanbio Laboratory, LP | Device | Class II | 1 |
| 13 Feb 2018 | Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60 | Hetero Labs Limited Unit V | Drug | Class II | 2 |
| 12 Feb 2018 | Pibb Xtra, Artificially Flavored Spicy Cherry Soda 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA | Heartland Coca-Cola Bottling Company | Food | Class II | 20 |
| 9 Feb 2018 | Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478 | Apace KY LLC | Drug | Class II | 1 |
| 9 Feb 2018 | White Quinoa; 16 oz. (454g) bags with clear panel in front; UPC: 0 72431 00195 6 Brand name Lunds & Byerlys Quinoa ingredients: White Quinoa Couscous ingredients: Israeli Couscous (wheat flour, rosemary extract). Contains: Wheat. Produced for Lunds & Byerlys, Edina, MN. (79208) | InHarvest, Inc. | Food | Class II | 1 |
| 8 Feb 2018 | BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired. | Medtronic Perfusion Systems | Device | Class II | 1 |
| 8 Feb 2018 | J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS | Bovie Medical Corporation | Device | Class II | 5 |
| 8 Feb 2018 | Product packaged in the following ways A) Sonne's, No. 17, Natural Source Vitamin C, Dietary Supplement, (920 mg tablet wt.) Contents - 120 Tablets, National Distributors: Sonne's Organic Foods, Inc. N. Kansas City, MO 64116; B) Springreen, No. 87, Natural Source Vitamin C, Dietary Supplement, (920 mg tablet wt.)… (79113) | Vitalab Co Inc | Food | Class II | 1 |
| 8 Feb 2018 | Weis Sunbury, PA 17801; Penne W/Asiago Sauce And Grilled Chix Small Meal; multiple weight. SCALE UPC - 205377-00000 | WEIS MARKETS | Food | Class I | 1 |
| 7 Feb 2018 | HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When… | Philips Electronics North America Corporation | Device | Class III | 1 |
| 7 Feb 2018 | Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01 | Pfizer Inc. | Drug | Class I | 2 |
| 6 Feb 2018 | Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 6 Feb 2018 | Pepitas - International Food Court brand, Thai Sweet Chili Roasted Pumpkin Kernels, 4 oz. vacuum sealed plastic bag, UPC 0 83066 16018 5 The label is read in parts: "***PEPITAS***THAI SWEET CHILI ROASTED PUMPKIN KERNELS***Ingredients: organic pumpkin seeds, pure cane sugar, vinegar, sea salt, red chiles, garlic,… (79184) | La Salsa Foods Inc | Food | Class II | 1 |
| 5 Feb 2018 | Meijer Greek Yogurt 0% Black Cherry 5.3 oz. The products are packaged in a plastic cup with a foil seal and a label listing the above-mentioned UPCs. | Meijer Distribution, Inc | Food | Class II | 6 |
| 2 Feb 2018 | 3M Surgical Clipper Professional 9681 | 3M Company - Health Care Business | Device | Class II | 1 |
| 2 Feb 2018 | Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups.… | Signature Orthopedics Pty Limited | Device | Class II | 1 |
| 2 Feb 2018 | SOUTHERN GROVE ALMONDS Unsalted 14 oz (397g) pouch bag INGREDIENTS: ALMONDS. Distributed by ALDI Inc. Batavia, IL 60510 UPC 0 41498 24647 1 | Kanan Enterprises, Inc. | Food | Class II | 1 |
| 1 Feb 2018 | smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 31 Jan 2018 | FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6 | 3M Company - Health Care Business | Device | Class II | 2 |
| 30 Jan 2018 | Sourdough Baguette: Product number 2064; SKU 61659798; GTIN [00046567600949]; UPC 831 49000064 20 pieces; Ingredients: Unbleached Wheat Flour, Water, Sea Salt, Starter (Fermented dough). Best Practices: 1. Keep Bread frozen at all times 2. Pull bread out of freezer 3. Preheat oven to 425 degrees F 4. Bake 12-15… | Sumano's Bakery | Food | Class II | 2 |
| 29 Jan 2018 | Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical… (79251) | Individual firm, name withheld | Device | Class II | 1 |
| 29 Jan 2018 | NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF… | NxStage Medical, Inc. | Device | Class II | 1 |
| 27 Jan 2018 | Fresh Fragrant Pear; Label - Double Trees Product of China Shenzhen J.F. Fruit Co., LTD (79061) | IQ PRODUCE, LLC | Food | Class III | 1 |
| 26 Jan 2018 | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System. (79116) | Individual firm, name withheld | Device | Class II | 1 |
| 26 Jan 2018 | ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 25 Jan 2018 | O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product… | Medtronic Navigation, Inc.-Littleton | Device | Class II | 1 |
| 25 Jan 2018 | CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs:… | Stryker Corporation | Device | Class II | 1 |
| 24 Jan 2018 | Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 057800062653 (79338) | Oxygen Development Llc | Drug | Class III | 1 |
| 24 Jan 2018 | Ready-to-Eat Powdered Peanut Butter in 1 lb (16 oz.) plastic jars (79057) | Bell Plantation Inc. | Food | Class II | 1 |
| 22 Jan 2018 | Divine Living Silver with harmonically structured frequencies A Wellness Solution 8 oz Ingredients: Structured Water, Pure Silver West Unity, Ohio 419-682-0918 (79032) | Divine Living | Food | Class II | 1 |
| 19 Jan 2018 | AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255 | Beckman Coulter Inc. | Device | Class II | 1 |
| 19 Jan 2018 | SwishTapered Implant Intended for use in support for fixed bridgework. | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 2 |
| 18 Jan 2018 | AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system. | Beckman Coulter Inc. | Device | Class II | 1 |
| 12 Jan 2018 | Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts one include cardiac angiography, neuro-angiography,… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 12 Jan 2018 | Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System. | Alcon Research, LTD. | Device | Class II | 2 |
| 12 Jan 2018 | Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46 | AuroMedics Pharma LLC | Drug | Class I | 1 |
| 11 Jan 2018 | IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 10 Jan 2018 | Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1 (79361) | Spirit Pharmaceuticals, LLC | Drug | Class II | 1 |
| 5 Jan 2018 | AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 4 Jan 2018 | Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 3 Jan 2018 | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 | Individual firm, name withheld | Device | Class II | 2 |
| 3 Jan 2018 | Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 2 |
| 3 Jan 2018 | Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0 | Philips Electronics North America Corporation | Device | Class II | 1 |
| 3 Jan 2018 | Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681) | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 2 Jan 2018 | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording… | Stryker Sustainability Solutions | Device | Class II | 2 |
| 29 Dec 2017 | INFX-8000F Fluoroscopic X-Ray Systems | Toshiba American Medical Systems Inc | Device | Class II | 4 |
| 27 Dec 2017 | BNS WHEAT ROLLS ( Under the following Trade Names - Giant, Harvest Pride, Shoppers and Old Tyme ) | Schmidt Baking Co., Inc. | Food | Class II | 26 |
| 21 Dec 2017 | ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections… | Arrow International Inc | Device | Class II | 1 |
| 20 Dec 2017 | SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600 | Boston Scientific Corporation | Device | Class II | 1 |
| 20 Dec 2017 | Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 20 Dec 2017 | DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451. | Fresenius Medical Care Renal Therapies Group, LLC | Drug | Class II | 1 |
| 19 Dec 2017 | OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic | Ventana Medical Systems Inc | Device | Class I | 12 |
| 15 Dec 2017 | Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching. | Trumpf Medical Systems, Inc. | Device | Class II | 1 |
| 13 Dec 2017 | INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013. | ALLERGAN | Drug | Class II | 1 |
| 12 Dec 2017 | Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy Catheter with its extended tip is also… | Boston Scientific Corporation | Device | Class II | 6 |
| 11 Dec 2017 | digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for all routine radiographic examinations,… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 8 Dec 2017 | ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT… | Abbott Laboratories, Inc | Device | Class II | 3 |
| 8 Dec 2017 | Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 7 Dec 2017 | 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pediatric femoral neck fractures, Tibial… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 5 Dec 2017 | Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS… | Ion Beam Applications S.A. | Device | Class II | 1 |
| 4 Dec 2017 | Ultra Renew | Accord Media, LLC | Device | Class II | 4 |
| 4 Dec 2017 | PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA) | Smiths Medical ASD Inc. | Device | Class II | 2 |
| 29 Nov 2017 | BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement | Zimmer Biomet, Inc. | Device | Class II | 48 |
| 28 Nov 2017 | The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf, LE¿O-110030120_REV D.pdf.pdf | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 27 Nov 2017 | DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.… | Ethicon, Inc. | Device | Class II | 1 |
| 27 Nov 2017 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple… | Arrow International Inc | Device | Class II | 12 |
| 24 Nov 2017 | U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis,… | United Orthopedic Corporation | Device | Class II | 2 |
| 22 Nov 2017 | ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material. | Atrium Medical Corporation | Device | Class II | 1 |
| 21 Nov 2017 | Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for… | Medica Corporation | Device | Class II | 1 |
| 20 Nov 2017 | Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as… | OMNIlife science Inc. | Device | Class II | 1 |
| 20 Nov 2017 | Agility with Integrity R3.2 | Elekta Limited | Device | Class II | 2 |
| 17 Nov 2017 | QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries | Z-Medica, LLC | Device | Class II | 1 |
| 17 Nov 2017 | 241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress Medical Products Skin Staple Remover Kit. McKesson Item # 241, 100123, and 100124, Cypress Item # 82-15 Manual surgical instrument for general use. | Cypress Medical Products LLC | Device | Class II | 1 |
| 17 Nov 2017 | StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520)… | Stryker Corporation | Device | Class II | 4 |
| 17 Nov 2017 | Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. | Ion Beam Applications S.A. | Device | Class II | 1 |
| 14 Nov 2017 | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation. | Arrow International Inc | Device | Class II | 9 |
| 13 Nov 2017 | Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following… | Smiths Medical ASD Inc. | Device | Class II | 3 |
| 10 Nov 2017 | NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One | NxStage Medical, Inc. | Device | Class II | 1 |
| 10 Nov 2017 | Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease. (79181) | Wiener Laboratories | Device | Class II | 1 |
| 10 Nov 2017 | MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for… | Zevex Incorporated (dba Moog Medical Medical Devices Group) | Device | Class II | 6 |
| 9 Nov 2017 | ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature. (79324) | Vascular Insights, LLC | Device | Class II | 1 |
| 9 Nov 2017 | GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04 (78541) | Kareway Products Inc | Drug | Class I | 1 |
| 7 Nov 2017 | T/Pump temperature therapy pump, Models TP700 and TP700C | Stryker Medical Division of Stryker Corporation | Device | Class III | 1 |
| 3 Nov 2017 | NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with otherwise nondiseased eyes. The lens may… | Alden Optical | Device | Class II | 11 |
| 2 Nov 2017 | Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908; (79364) | Epigenomics Ag | Device | Class II | 1 |
| 1 Nov 2017 | Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by… | Ion Beam Applications S.A. | Device | Class II | 1 |
| 31 Oct 2017 | Dark Chocolate Covered Almonds 9 oz clam shell & 25 lb box Ingredients: Dark Chocolate (Sugar, chocolate Liquor, Cocoa Butter, Chocolate Liquor Processed with Alkali, Soy Lecithin (Emulsifier), Salt, Vanilla, Almonds and Confectioners Glaze. Sold under the brand names and Distributed by: Sage Valley St. Augustine, FL… (79376) | WHOLE ALTERNATIVES LLC | Food | Class II | 1 |
| 25 Oct 2017 | fastener, fixation, nondegradable, soft tissue | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 25 Oct 2017 | Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT). | Diagnostica Stago, Inc. | Device | Class II | 4 |
| 24 Oct 2017 | Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can… (79352) | Medtronic Minimally Invasive Therapies Group | Device | Class II | 1 |
| 23 Oct 2017 | Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures. | Alto Development Corp | Device | Class II | 1 |
| 23 Oct 2017 | SKIN STAPLE REMOVER | Centurion Medical Products Corporation | Device | Class II | 21 |
| 20 Oct 2017 | Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures. | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 19 Oct 2017 | Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding | Cook Inc. | Device | Class II | 3 |
| 19 Oct 2017 | Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.… | Ion Beam Applications S.A. | Device | Class II | 1 |
| 17 Oct 2017 | Proteus 235, graphite block 8 | Ion Beam Applications S.A. | Device | Class II | 1 |
| 17 Oct 2017 | BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated… | Siemens Healthcare Diagnostics | Device | Class II | 1 |
| 14 Oct 2017 | MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316. (79319) | Medtronic Minimally Invasive Therapies Group | Device | Class II | 1 |
| 13 Oct 2017 | Amplatz Extra Stiff Whisker Wire Guide | Cook Inc. | Device | Class II | 20 |
| 12 Oct 2017 | Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device that is sewn into the green pouch that you… | Covidien LLC | Device | Class II | 1 |
| 11 Oct 2017 | TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction. | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 10 Oct 2017 | SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS; OS900055-NS; OS900056-NS; OS900058-NS; OS900059-NS;… (79218) | ORTHO SOLUTIONS, LTD. | Device | Class II | 1 |
| 6 Oct 2017 | Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability. | CooperSurgical, Inc. | Device | Class II | 1 |
| 6 Oct 2017 | Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and cover, the IV Port connector and an integrated… (79243) | Medimop Medical Projects Ltd. | Device | Class II | 1 |
| 6 Oct 2017 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 5 Oct 2017 | MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation. | Monteris Medical Corp | Device | Class I | 1 |
| 5 Oct 2017 | 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 5 Oct 2017 | Philips Network Firewall (Cisco ASA 5506), Model # 867098 | Philips Electronics North America Corporation | Device | Class II | 1 |
| 4 Oct 2017 | INFINITY DUAL HEMO MCable Pod | Draegar Medical Systems, Inc. | Device | Class II | 1 |
| 3 Oct 2017 | Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use. | Degania Silicone, Ltd. | Device | Class III | 1 |
| 3 Oct 2017 | Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04 | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 3 Oct 2017 | Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency. | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. | Device | Class II | 1 |
| 3 Oct 2017 | Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when increased purity is required. | Becton Dickinson & Co. | Device | Class II | 1 |
| 3 Oct 2017 | Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 2 Oct 2017 | SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by these systems can be used by a trained physician as an aid in diagnosis.… | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 30 Sep 2017 | O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, and is intended to be… | Medtronic Navigation, Inc.-Littleton | Device | Class II | 1 |
| 29 Sep 2017 | NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 28 Sep 2017 | Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin. (78479) | Cosmedent, Inc. | Device | Class II | 1 |
| 28 Sep 2017 | V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000) | Steris Corporation | Device | Class II | 1 |
| 28 Sep 2017 | Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813. | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 26 Sep 2017 | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg). | Mobius Imaging, LLC | Device | Class II | 1 |
| 26 Sep 2017 | Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 22 Sep 2017 | Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers) | Circulatory Technology Inc | Device | Class II | 2 |
| 22 Sep 2017 | Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated. | Angiodynamics, Inc. | Device | Class II | 1 |
| 22 Sep 2017 | Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures. | Boston Scientific Corporation | Device | Class II | 2 |
| 22 Sep 2017 | VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic | Ortho-Clinical Diagnostics | Device | Class II | 5 |
| 21 Sep 2017 | proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 20 Sep 2017 | Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B | Merit Medical Systems, Inc. | Device | Class II | 3 |
| 15 Sep 2017 | Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis,… | Covidien LLC | Device | Class II | 1 |
| 15 Sep 2017 | 36MM COCR MODULAR HD -6MM | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 13 Sep 2017 | Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument | Zimmer Biomet, Inc. | Device | Class II | 3 |
| 12 Sep 2017 | Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries. | Terumo Medical Corporation | Device | Class II | 1 |
| 12 Sep 2017 | OTTO BOCK Kenevo knee joints Model 3C60 | Otto Bock Healthcare Product | Device | Class II | 2 |
| 12 Sep 2017 | i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255) | Abbott Point Of Care Inc. | Device | Class II | 1 |
| 8 Sep 2017 | AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion of the intervertebral… | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 7 Sep 2017 | The 2nd Assist Knee Positioner | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 1 Sep 2017 | Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic… | CooperVision Inc. | Device | Class III | 1 |
| 31 Aug 2017 | Syngo.via systems with SW VB20A | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 31 Aug 2017 | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only. | DePuy Orthopaedics, Inc. | Device | Class II | 2 |
| 31 Aug 2017 | 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures. | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 1 |
| 31 Aug 2017 | LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for… | Laerdal Medical Corporation | Device | Class II | 1 |
| 29 Aug 2017 | BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening. | Becton Dickinson & Company | Device | Class II | 1 |
| 25 Aug 2017 | Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate… | Keystone Dental Inc | Device | Class II | 1 |
| 22 Aug 2017 | Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 18 Aug 2017 | A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 17 Aug 2017 | Coated VICRYL RAPIDETM (Polyglactin 910) Suture | Ethicon, Inc. | Device | Class II | 1 |
| 14 Aug 2017 | ReWalk Personal 6.0. Catalog number: 50-20-0004. (79186) | Argo Medical Technologies Ltd | Device | Class II | 1 |
| 11 Aug 2017 | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) | Randox Laboratories | Device | Class III | 2 |
| 9 Aug 2017 | Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637… (78609) | Individual firm, name withheld | Device | Class II | 1 |
| 8 Aug 2017 | Liquid Cardiac Control CQ5053 | Randox Laboratories, Limited | Device | Class II | 1 |
| 8 Aug 2017 | REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. (79136) | LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC | Device | Class II | 1 |
| 4 Aug 2017 | OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL¿… | ZOLL Medical Corporation | Device | Class II | 1 |
| 2 Aug 2017 | Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 | Instrumentation Laboratory Co. | Device | Class II | 1 |
| 2 Aug 2017 | JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. (79015) | Perkinelmer Life Sciences, Inc. | Device | Class III | 1 |
| 1 Aug 2017 | Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal… | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 31 Jul 2017 | Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table OAKWORKS¿ Medical CFPM 400 Imaging Table OAKWORKS¿ Medical CFPM 401 Imaging Table OAKWORKS¿ Medical CFPMB 301 Bariatric Imaging Table OAKWORKS¿ Medical CFUR 301 Urology Table OAKWORKS¿… | Oakworks Inc | Device | Class II | 1 |
| 28 Jul 2017 | ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of triiodothyronine are used in the diagnosis and treatment of thyroid disease. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 26 Jul 2017 | 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery. | Synthes (USA) Products LLC | Device | Class II | 7 |
| 26 Jul 2017 | Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine. | DePuy Orthopaedics, Inc. | Device | Class II | 2 |
| 21 Jul 2017 | Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737 | Howmedica Osteonics Corp. | Device | Class II | 2 |
| 19 Jul 2017 | GENICON EZEE Retrieval, sterile, Rx only. | Genicon, Inc. | Device | Class II | 1 |
| 18 Jul 2017 | cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V | Roche Diagnostics Corporation | Device | Class II | 2 |
| 14 Jul 2017 | A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is… | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 2 |
| 10 Jul 2017 | VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. | Ortho Clinical Diagnostics Inc | Device | Class III | 1 |
| 30 Jun 2017 | 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are… | ZOLL Medical Corporation | Device | Class II | 1 |
| 30 Jun 2017 | DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 22 Jun 2017 | The GC80 Digital X-ray Imaging System | NeuroLogica Corporation | Device | Class II | 1 |
| 22 Jun 2017 | AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09 | Avid Medical, Inc. | Device | Class II | 23 |
| 19 Jun 2017 | STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2¿ Secondary Set Gravity Flow Controller, 20 Drops/ml, 13 length, (4)… | ConMed Corporation | Device | Class II | 2 |
| 16 Jun 2017 | Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw. | Keystone Dental Inc | Device | Class II | 1 |
| 15 Jun 2017 | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly… | Steris Corporation | Device | Class II | 29 |
| 6 Jun 2017 | Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355 | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 25 Apr 2017 | MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions. (78973) | Individual firm, name withheld | Device | Class II | 1 |
| 3 Mar 2017 | LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures. | Bausch & Lomb Inc Irb | Device | Class II | 44 |
| 10 Jan 2017 | Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation. | Teleflex Medical | Device | Class II | 1 |
| 15 Oct 2015 | DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B),… | Euro Diagnostica AB | Device | Class II | 1 |
| 9 Nov 2011 | ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests. | Individual firm, name withheld | Device | Class II | 2 |