| 14 Oct 2019 | Samurai Brand Furikake Popcorn Net Wt. 5 oz. (142g), foil bag - sold by single bag or case of 20 Made in Hawaii BAG UPC: 6 16720 40004 6; Case UPC: 6 16720 41004 5. Event 84047 | Samurai, Inc. | Food | Class I | 1 |
| 9 Oct 2019 | Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839 | Ingenus Pharmaceuticals Llc | Drug | Class II | 1 |
| 9 Oct 2019 | PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25 | Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center | Drug | Class II | 3 |
| 9 Oct 2019 | Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10 | Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center | Drug | Class II | 2 |
| 7 Oct 2019 | Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60. Event 83914 | Mylan Laboratories Limited (Sterile Products Division) | Drug | Class II | 1 |
| 7 Oct 2019 | Orchids Dried Mushroom NET WT. 1 oz. (29G) Product of China UPC 0-74601-00947-2 Distributed by CTC Food International, Inc. Richmond, CA 94804 Event 83995 | CTC Food International Inc | Food | Class III | 1 |
| 7 Oct 2019 | Dole Crushed Pineapple in 100% pineapple juice Manufactured For Dole Packaged Foods, LLC Westlake Village, CA 91361 Product of The Philippines UPC 3890000613 | Dole Packaged Foods, LLC | Food | Class II | 1 |
| 4 Oct 2019 | Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50. | KVK-Tech, Inc. | Drug | Class III | 1 |
| 4 Oct 2019 | Nana's Been a Nut Bread NET WT. 11oz/311.74g cloth bag CONTAINS WHEAT AND SOY. MADE ON EQUIPMENT THAT MAKES PRODUCTS CONTAINING WHEAT, EGGS, MILK, SOY AND TREE NUTS. GULLAH BOURMET Inc. CHARLESTON, SC 29407 UPC 6 50305 01045 9 Event 83936 | Gullah Gourmet, Inc. | Food | Class II | 1 |
| 3 Oct 2019 | Frozen blackberries, packaged in 16 ounce (454 gram) plastic bags (12 bags per master case). Plastic bags labeled with: PREMIUM QUALITY, KEEP FROZEN, NON-GMO, CORNERSTONE PREMIUM FOODS, Blackberries, GREAT FOR SMOOTHIES, NET WEIGHT 16 OZ. (454g), INGREDIENTS: BLACKBERRIES, GC 1 092 9, PROD. CODE 16924, PROD. OF… Event 83967 | G&C Food Distributors, Inc. | Food | Class II | 1 |
| 3 Oct 2019 | Dried Mushroom NET WT: 8oz (227g) Ingredients: Mushroom Distributed By: Arcadia Trading Inc. Brooklyn, NY 11211. USA Product of China UPC: 791804603091 Event 83854 | Arcadia Trading Inc. | Food | Class III | 1 |
| 3 Oct 2019 | Climax Spring Water bottled in 5 gallon, 1 gallon, and 16.9 ounce plastic bottles (12 bottles per case) Event 83923 | King Bottling, Inc. | Food | Class III | 1 |
| 2 Oct 2019 | 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13 | Pfizer Inc. | Drug | Class II | 1 |
| 1 Oct 2019 | Fetting's Family Breads, White Bread, 4-1 lb. loaves. Net Wt. 4 lbs. (1.81 kg) UPC code 75812-79216 Event 83932 | Fetting's Frozen Foods LLC | Food | Class II | 1 |
| 1 Oct 2019 | Tep Say Crispy Tiny Shrimp Snack, Net Wt. 7 oz. in plastic jar UPC 7 37483 77926 9 Distributed By: First World Trading Corp. Fremont, California Tel: (510) 683-8778 Event 83894 | Vinh Sanh Trading Corp | Food | Class II | 1 |
| 1 Oct 2019 | Jansal Valley brand Indulgent Snack Mix NET WT 12 OZ (340 G) in plastic clamshells, Ingredients: apricots, almonds, banana chips, coconut, cashews, dates, raisins, hazelnuts, pecans, pepitas, walnuts, papaya, pineapple. Contains: almonds, cashews, soy. This product is packaged in a facility that also packages tree… | Friendly Fruit Market dba Sid Wainer & Son | Food | Class II | 2 |
| 1 Oct 2019 | Chicken Salad on White Bread Sandwich, Net Wt. 5 oz. 142g), packaged as follows: 1. Deli Express, Keep Refrigerated, UPC 41433-02118, EA Sween Company, Eden Prairie, MN 55344 2. K&G, UPC 08615-35576. Distributed By: Kum & Go L.C. West Des Moines, IA 50266. | E.A. Sween Co. | Food | Class I | 14 |
| 1 Oct 2019 | Tia Rita's Spicy Southwestern Green Chile Cornbread dry mix. Packaged in 13 oz (380 g) sealed plastic bags with paper label stapled over the top edge of each package, 12 packages per case. UPC 44107 10062. Mfg. by The Truck Farm, LLC. Las Cruces, NM 88005. Event 83918 | The Truck Farm, LLC | Food | Class II | 1 |
| 1 Oct 2019 | Premo and Fresh Grab Chicken Salad wheat sandwiches, 5 oz., with UPC code 612510002032. | Lipari Foods Operating Company, LLC. | Food | Class I | 3 |
| 1 Oct 2019 | Chicken Salad on Marble Rye, UPC 2 05118-XXXXX. Keep Refrigerated. | Coborn's, Inc | Food | Class I | 3 |
| 30 Sep 2019 | Frozen, raw tuna steaks individually packed in 8 oz. vacuum packages. Sold in cardboard cases (10 Lbs. per case). | Northern Fisheries Ltd. | Food | Class II | 2 |
| 30 Sep 2019 | Tuna salad under the following brand names: BALLARDS FARM Barboursville, WV 25504 UPC 076010000293 12 oz. plastic container, LAURA LYNN UPC 086854035368 12 oz. plastic container, MRS. STRATTON S SALADS Birmingham, AL 35219 UPC 075217100294 12 oz. plastic container, STAR FOOD PRODUCTS Burlington, NC 27215 UPC… Event 83945 | Name withheld | Food | Class I | 1 |
| 30 Sep 2019 | Chicken Salad Sandwiches packaged under the following brands: 1. Supermom's Kitchen Classic, Keep Refrigerated, UPC 7 63913-80128 6, Net Wt. 4.5 oz. (128g), MFG By Supermom's, St. Paul Park, MN 55071 2. Hometown Kitchen Select, Keep Refrigerated, UPC 7 63913-26015, Net Wt. 4.5 oz. (128g), Mfg By Hometown Kitchen 625… Event 83949 | Northern Tier Bakery LLC dba SuperMom's | Food | Class I | 1 |
| 30 Sep 2019 | Consider Bardwell Farm Dorset cheese PLU code 97776 sliced and wrapped in plastic cling with Whole Foods Market scale label applied | Whole Foods Market | Food | Class I | 1 |
| 29 Sep 2019 | Consider Bardwell Farm brand Slyboro Handmade Goat Cheese - Ingredients Raw Goat Milk, Cultures, Salt, Microbial Rennet - 2 lb Wheel - Consider Bardwell Farm, LLC 133 RTE. 153 W.Pawlet, Vermont 05775 | Consider Bardwell Farm, LLC | Food | Class I | 3 |
| 27 Sep 2019 | Dunkin' Mocha Swirl Prepared Exclusively for Dunkin' Brands Canton, MA 02021 Net Contents 64 FL OZ/1.89L Not For Resale | Lyons Magnus, Inc | Food | Class I | 1 |
| 26 Sep 2019 | Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9 | Life Technologies Holdings Pte Ltd | Device | Class II | 4 |
| 26 Sep 2019 | Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles.… | Alkermes, Inc. | Drug | Class II | 1 |
| 26 Sep 2019 | Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01 Event 83849 | Epic Pharma, LLC | Drug | Class II | 1 |
| 26 Sep 2019 | Ample Hills Peppermint Pattie ice cream packed in 3 gallon tubs and half pint (8oz) cartons . Allergens: Contains: eggs, milk, soy Event 83958 | AMPLE HILLS MANUFACTURING | Food | Class I | 1 |
| 26 Sep 2019 | Trails End Sweet and Savory Collection, containing White Cheddar cheese Corn (5 oz.), Butter Toffee Carmel Corn (20 oz.), and Chocolatey Caramel Crunch (15 oz.) each in individual foil bags packaged together in variety box Event 83920 | Name withheld | Food | Class II | 1 |
| 26 Sep 2019 | NIKKENWELLNESS KENZEN brand Calcium Complex Dietary Supplement 60 Tablets. Label reads "Contains ingredients derived from dairy" under Recommended Use. Event 83911 | Name withheld | Food | Class III | 1 |
| 25 Sep 2019 | Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA… | Brainlab AG | Device | Class II | 1 |
| 25 Sep 2019 | Koppers Chocolate Dark Chocolate Gummy Bears, 4oz (113g) retail package, metallized foil resealable pouch, 12 pouches per case Event 83961 | The Newark Nut Store | Food | Class II | 1 |
| 25 Sep 2019 | OXZGEN Performance 25 mg Hemp Derived CBD + Teacrine + BCAA Orange Flavored, 5 blast caps, 2.2 FL OZ | Hall Global, LLC | Food | Class II | 2 |
| 24 Sep 2019 | Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10 | Amneal Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 24 Sep 2019 | Nori Ajitsuke 100P SK 8.81 oz. (250 g) UPC 074410528288 Item #52818 | Wismettac Asian Foods, INC | Food | Class III | 1 |
| 24 Sep 2019 | Chef Pierre SMALL WHOLE GRAIN BANANA MUFFINS NET WT 12 LB (5.44kg) 4 TRAYS/24/2 oz WHOLE GRAIN BANANA MUFFINS KEEP FROZEN CONTAINS WHEAT, EGGS DISTRIBUTED BY TYSON FOOD SERVICE SPRINGDALE, AR 72765-2020 UPC (01) 1 00 32100 08896 8 Event 83885 | Sara Lee Frozen Bakery | Food | Class I | 1 |
| 24 Sep 2019 | Massey Fish Company Smoked Whitefish Pate, in a refrigerated 8 oz. plastic tub, with UPC number 854656007018 Event 83877 | Massey Fish Company | Food | Class I | 1 |
| 23 Sep 2019 | Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60 | Sandoz, Inc | Drug | Class II | 3 |
| 23 Sep 2019 | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08 | Morton Grove Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 23 Sep 2019 | DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026 | Unipharma, Llc. | Drug | Class II | 2 |
| 23 Sep 2019 | Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 33342-054-07 | Macleods Pharma Usa Inc | Drug | Class II | 1 |
| 23 Sep 2019 | Frozen Organic Blueberries Packed into Poly Bag, Net Weight 3 lbs. Product of USA. Item 815544, Kirkland Signature brand. UPC 0 96619 08155 4. Distributed by: Costco Wholesale Corporation P.O. Box 34535 Seattle, WA 98124-1535 USA. Event 83865 | Scenic Fruit Company | Food | Class II | 1 |
| 20 Sep 2019 | Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15. | Akorn, Inc. | Drug | Class II | 1 |
| 20 Sep 2019 | Capitan K Salmon slightly salted piece - net.wt 1.05 oz (200g) Distributed by: Euphoria Fancy Food Inc. 149-151 2nd avenue Brooklyn, New York 11215, USA Product of Russia UPC: 607059000362 Event 83876 | Euphoria Fancy Food Inc | Food | Class I | 1 |
| 20 Sep 2019 | Roland Brand Black Caviar - Whole Grain Lumpfish (Lumpfish Roe) packed in glass jars - 2oz & 2x2oz, UPC: 41224200029; 3.5oz, UPC: 41224200203; 12oz, UPCs: 41224200401 & 41224200425 | Roland Foods, LLC | Food | Class I | 2 |
| 19 Sep 2019 | Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory | Xodus Medical Inc | Device | Class II | 3 |
| 19 Sep 2019 | MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm Event 83934 | CrossRoads Extremity Systems, LLC | Device | Class II | 1 |
| 19 Sep 2019 | Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01 | Aurobindo Pharma USA Inc. | Drug | Class II | 1 |
| 19 Sep 2019 | Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10 | Torrent Pharma Inc. | Drug | Class II | 4 |
| 19 Sep 2019 | Wow Beef Dry Marinade Seasoning, 12.474 kg paper bags Event 83856 | Symrise Inc. | Food | Class II | 1 |
| 19 Sep 2019 | Espinaler Razor Clams (Trimmed) 4/6 Classic Line, " N4R-LE7R printed on the tin AND/OR E7R MM/YYYY printed on the box. (EAN CODE 8427230010494), 120 g, Aluminum tin in paper carton, Manufactured by: Ca l Espinaler SL Barcelona, Spain Event 83845 | YTM, Inc. DBA A Priori Specialty Foods | Food | Class II | 1 |
| 18 Sep 2019 | EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-volume sterile… | Baxter Healthcare Corporation | Device | Class II | 1 |
| 18 Sep 2019 | Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30 Event 83835 | GCP Laboratories Inc | Drug | Class II | 1 |
| 18 Sep 2019 | Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20 | Avella of Deer Valley, Inc. Store 38 | Drug | Class II | 1 |
| 18 Sep 2019 | Shirakiku Buckwheat Noodles Yamaimo Soba With Concentration Soup Base, 435G SK, UPC 074410455200 Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670 | Wismettac Asian Foods, INC | Food | Class II | 1 |
| 17 Sep 2019 | Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30 | Akorn, Inc. | Drug | Class II | 1 |
| 17 Sep 2019 | SE Grocers **BAKERY** 18 CT Peanut Butter Cookies | SOUTHEASTERN GROCERS - MARKETI | Food | Class I | 2 |
| 17 Sep 2019 | Peanut Butter Chocolate Chip Cookie, net wt. 2 oz. The product was distributed frozen and has a 5-day shelf life after being defrosted at the stores. The label is read in parts: "***Peanut Butter Chocolate Chip Cookie*** Ingredients: Peanut Butter, evaporated cane juice, brown sugar, sunflower oil, almond milk,… | Whole Flower Farms LLC | Food | Class II | 5 |
| 16 Sep 2019 | Gold Medal Enriched, Presifted, Unbleached All Purpose Flour, Net Wt. 5 lb (2.26 kg), in paper bags. UPC 16000-19610 | General Mills, Inc | Food | Class II | 1 |
| 14 Sep 2019 | Trail's End Chocolatey Carmel Crunch, in 15oz fundraiser tin, distributed in six count wholesale cases marked as ACP Caramel Corn w/almonds. Event 83810 | Name withheld | Food | Class II | 1 |
| 13 Sep 2019 | Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1323-00. | GUERBET LLC | Drug | Class II | 2 |
| 13 Sep 2019 | Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case. | Abbott Laboratories | Food | Class II | 1 |
| 13 Sep 2019 | MOWI brand. Whole, head-on gutted farmed, fresh Atlantic Salmon packed with ice inside Styrofoam coolers. Each cooler weighs approximately 47 lbs. Event 83821 | MOWI USA, LLC | Food | Class II | 1 |
| 13 Sep 2019 | Conventional Basil with Basil Infinite Herbs & Specialties brand label. Basil was packed in 2.5 oz plastic clamshell, 4.0 oz. plastic clamshell, and 1 lb plastic bags. | Infinite Herbs, LLC | Food | Class II | 1 |
| 12 Sep 2019 | Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. | Integra LifeSciences Corp. | Device | Class II | 1 |
| 12 Sep 2019 | Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack | Olympus Corporation of the Americas | Device | Class II | 1 |
| 12 Sep 2019 | ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2 | Pfizer Inc. | Drug | Class III | 2 |
| 12 Sep 2019 | Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06 | Spectrum Laboratory Products | Drug | Class II | 1 |
| 12 Sep 2019 | Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205 | KRS Global Biotechnology, Inc | Drug | Class II | 80 |
| 12 Sep 2019 | Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02 | Shire Human Genetic Therapies, Inc. | Drug | Class I | 4 |
| 12 Sep 2019 | Irish Salmon Organic Atl HON; 55 lb. cases received. Fresh Irish Salmon Fillet Ireland Farmed. Random weight boxes fillets cut and distributed. Keep Refrigerated, Color Added. Packed by Star Fisheries Inc., Wilmington, CA Event 83795 | Star Fisheries, Inc. | Food | Class II | 1 |
| 12 Sep 2019 | Jayleaf Fresh Baby Spinach; 4 lb. box (1 x 4 lb. bag) and 12 lb. crate (3 x 4 lb. bags); Refrigerate Event 83823 | Name withheld | Food | Class I | 1 |
| 11 Sep 2019 | Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems. | Roche Diagnostics Operations, Inc. | Device | Class III | 2 |
| 11 Sep 2019 | OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement. | OMNIlife science Inc. | Device | Class II | 1 |
| 11 Sep 2019 | Greenland All Natural Gourmet Crispy Fried Onions NET WT 400g UPC 5415685068 packaged in foil bag then carton; Chirag Gourmet Crispy Fried Onion Net Weight 400 Grams/14 oz. UPC 6421832035 packaged in foil bag then carton Event 83842 | Lion Foods | Food | Class II | 1 |
| 11 Sep 2019 | Premo brand Bologna & Cheese Wedge, refrigerated 5 oz. wedge cut sandwich, UPC 612510093306. | Lipari Foods Operating Company, LLC. | Food | Class I | 6 |
| 11 Sep 2019 | Black Rise Umeboshi Bowl; 12 oz. UPC: 813377 022595 | Name withheld | Food | Class I | 4 |
| 11 Sep 2019 | FuPaiYuan "***NOUGAT CANDIES***20190424***Candy***NET WT 450G (15.8oz)***INGREDIENTS Glucose syrup, sugar, peanut, shortening, salt, food additives (Gelatin)***Allergies: Contains peanuts***RONG SHING TRADING NY INC***47-57 BRIDGEWATER STREET BROOKLYN NY, 11222***BEST BEFORE: 01.23.2020***" | Rong Shing Trading NY Inc | Food | Class I | 2 |
| 10 Sep 2019 | Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use. | Exactech, Inc. | Device | Class II | 1 |
| 10 Sep 2019 | Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser. | Candela Corporation | Device | Class II | 4 |
| 10 Sep 2019 | Ritter Sport KAFFEESPLITTER Chocolate with caramelized coffee beans; Net Weight: 3.5oz / 100g; Ingredients: sugar, cocoa mass, caramelized pieces of coffee beans (sugar, coffee (roasted) (4%), sunflower oil), cocoa butter, butter pure fat, emulsifier: lecithin (soy) May contain traces of peanuts, nuts, and egg.… Event 83784 | STARK INC. | Food | Class II | 1 |
| 10 Sep 2019 | Popchips Sea Salt Potato Popped Chips; 5 oz. bag, 0.8 oz. bag UPC: 0 82666 50080 3 - 5 oz. ; UPC: 0 82666 71100 1 - 8 oz. | SONORA MILLS FOODS INC DBA POPCH | Food | Class II | 4 |
| 10 Sep 2019 | Source Naturals Dietary Supplement Brain Charge Advanced Cognitive Support 30 tablets, 60 tablets Manufactured for: Source Natural, Inc. PO Box 2118 Santa Cruz, CA 95062 Item Code: SN2613, SN2614 Item UPC: 021078026136, 021078026143 | Threshold Enterprises Ltd | Food | Class III | 1 |
| 9 Sep 2019 | Hy-Vee Mealtime Fried Rice in a 16 oz. black plastic container with clear plastic lid Event 83766 | Hy-Vee | Food | Class I | 1 |
| 6 Sep 2019 | MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper is intended for the removal of body hair from the patient as required prior to surgery or other minor procedures. | Medline Industries Inc | Device | Class II | 1 |
| 6 Sep 2019 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 52544-692-30 | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 6 Sep 2019 | Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42. Event 83731 | Cardinal Health dba Specialty Pharmaceutical Services | Drug | Class II | 1 |
| 6 Sep 2019 | Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707 Event 83734 | Darmerica, LLC | Drug | Class I | 1 |
| 6 Sep 2019 | Udi's Classic Hamburger Buns, packaged in a 10.4 oz. plastic bag, with eight bags per wholesale case. UPC 00-6-98997-80913-5 . | ConAgra Foods, INc. | Food | Class II | 1 |
| 6 Sep 2019 | Alfa International Seafood Miami, Fl, 8402, Yellowfin Tuna Loins, Previously Frozen, Wild Caught, Product of Vietnam Event 83764 | ALFA INTERNATIONAL SEAFOOD INC | Food | Class II | 1 |
| 5 Sep 2019 | Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish… | CooperSurgical, Inc. | Device | Class III | 1 |
| 5 Sep 2019 | Silk Soymilk Vanilla Bag-In-Box. One, 2.5 gallon bag per box. 2.5 gal Bag-In-Box to be used in a dispensing machine at foodservice & convenience outlets. Event 83736 | DANONE | Food | Class II | 1 |
| 4 Sep 2019 | Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy,… | Elekta Inc | Device | Class II | 2 |
| 4 Sep 2019 | Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90 | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 3 Sep 2019 | Achilles Insight Bone Sonometer | GE Healthcare, LLC | Device | Class II | 2 |
| 3 Sep 2019 | Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X,… | Medtronic Vascular Galway DBA Medtronic Ireland | Device | Class II | 2 |
| 1 Sep 2019 | Apetina Marinated Olives & Feta in Olive Oil, packed in 3.1 LB pals; 4 pals/case; UPC: 0009393605697 | UNFI General Corporate | Food | Class II | 1 |
| 30 Aug 2019 | ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures… | GE Healthcare, LLC | Device | Class II | 1 |
| 30 Aug 2019 | Madrona Market Delicatessen Hot Cocoa Mix, Net Wt. 2 lb (907 g), Distributed by Food Services of America, Inc. Scottsdale, AZ packaged 6 boxes per case. | Diamond Crystal Brands Inc | Food | Class II | 3 |
| 29 Aug 2019 | Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09 | Preferred Pharmaceuticals, Inc | Drug | Class II | 1 |
| 29 Aug 2019 | Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001. | Johnson Matthey Inc. | Drug | Class II | 3 |
| 28 Aug 2019 | cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122 | Roche Diagnostics Operations, Inc. | Device | Class II | 2 |
| 28 Aug 2019 | Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR | Centurion Medical Products Corporation | Device | Class II | 2 |
| 28 Aug 2019 | Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50. Event 83710 | Atlas Pharmaceuticals, LLC | Drug | Class II | 1 |
| 28 Aug 2019 | Tostitos Medium Salsa Con Queso 23 oz. packaged in a clear glass jar UPC 2840006740 | Frito-Lay, Inc. | Food | Class III | 3 |
| 26 Aug 2019 | minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St.… Event 83809 | EPI Health, LLC | Drug | Class III | 1 |
| 26 Aug 2019 | Valencia Sopaipilla and Fry Bread Mix, 25 lbs, packaged in Paper bags with polyliners. UPC 7 30701 22025 3 | Valencia Flour Mill, Ltd. | Food | Class II | 3 |
| 22 Aug 2019 | iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right | Conformis, Inc. | Device | Class II | 2 |
| 22 Aug 2019 | The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including… | GETINGE US SALES LLC | Device | Class II | 1 |
| 21 Aug 2019 | BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope… | AZIYO BIOLOGICS | Device | Class II | 2 |
| 21 Aug 2019 | Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder… | Zimmer GmbH | Device | Class II | 1 |
| 21 Aug 2019 | H-E-B Select Ingredients Creamy Creations Strawberry Ice Cream 1/2 gallon UPC 4122034602 packaged in paper carton with lid | H-E-B GROCERY COMPANY LP DBA HEB | Food | Class II | 1 |
| 20 Aug 2019 | 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue. Event 83650 | Repro-Med Systems, Inc. | Device | Class II | 1 |
| 20 Aug 2019 | TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460 | Quality Electrodynamics LLC | Device | Class II | 7 |
| 20 Aug 2019 | Decorated Red Apple Cookies sold in display case in retail stores | Whole Foods Market | Food | Class I | 1 |
| 19 Aug 2019 | OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032 | OrthoPediatrics Corp | Device | Class II | 1 |
| 19 Aug 2019 | TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See… | Howmedica Osteonics Corp. | Device | Class II | 4 |
| 19 Aug 2019 | BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes | Becton, Dickinson and Company, BD Biosciences | Device | Class II | 9 |
| 16 Aug 2019 | Irrisept Wound Debridement and Cleansing System. 12 units per case. Event 83599 | IrriMAX Corporation | Device | Class II | 1 |
| 15 Aug 2019 | Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 15 Aug 2019 | QuickGraft Model # 430PST | Musculoskeletal Transplant Foundation, Inc. | Device | Class II | 1 |
| 15 Aug 2019 | Frozen Whole Yellow Tail Fusiler-200 Up | Foremost Foods International, Inc. | Food | Class II | 1 |
| 14 Aug 2019 | Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies. | WOM World of Medicine AG | Device | Class II | 1 |
| 14 Aug 2019 | Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 13 Aug 2019 | STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture | Ethicon, Inc. | Device | Class II | 2 |
| 13 Aug 2019 | AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001 | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 13 Aug 2019 | EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent administration of liquid medication and… | Baxter Healthcare Corporation | Device | Class III | 1 |
| 9 Aug 2019 | Proteus XR/a (SlOK : K993090) | GE Healthcare, LLC | Device | Class II | 1 |
| 6 Aug 2019 | 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular,… | Arrow International Inc | Device | Class II | 2 |
| 1 Aug 2019 | Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap… Event 83491 | Name withheld | Device | Class II | 1 |
| 31 Jul 2019 | C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 2 |
| 31 Jul 2019 | BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer Push… | Becton Dickinson & Company | Device | Class II | 1 |
| 30 Jul 2019 | Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 29 Jul 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 unit per pouch; 48 pouches per case. | ICU Medical Inc | Device | Class II | 22 |
| 25 Jul 2019 | Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips. | Randox Laboratories Ltd. | Device | Class III | 1 |
| 24 Jul 2019 | C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Colonia Care Pharmacy | Drug | Class II | 32 |
| 23 Jul 2019 | Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502 | Roche Diagnostics Operations, Inc. | Device | Class II | 2 |
| 23 Jul 2019 | Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 18 Jul 2019 | Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The… | Arrow International Inc | Device | Class II | 1 |
| 16 Jul 2019 | xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test Event 83472 | Luminex Molecular Diagnostics | Device | Class II | 1 |
| 9 Jul 2019 | Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing… | Voco GmbH | Device | Class II | 1 |
| 8 Jul 2019 | GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5. NDL, GRIPPER, 19G X 1.25" (32MM), 12/BX; 6. NDL, GRIPPER, 22G X… | Smiths Medical ASD Inc. | Device | Class II | 2 |
| 28 Jun 2019 | MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30 | Sentinel CH SpA | Device | Class II | 2 |
| 27 Jun 2019 | Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700 | Inter-Med Llc | Device | Class II | 7 |
| 26 Jun 2019 | IMRIS MR/X-ray head fixation device, Model HFD200 | Deerfield Imaging, Inc. | Device | Class II | 1 |
| 19 Jun 2019 | Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap. | Andover Healthcare Inc. | Device | Class II | 6 |
| 30 May 2019 | Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P | Paltop Advanced Dental Solutions Ltd | Device | Class II | 1 |
| 28 May 2019 | The ICS CHARTR EP 200 Event 83380 | Name withheld | Device | Class II | 1 |
| 17 May 2019 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access | Arrow International Inc | Device | Class II | 1 |
| 13 May 2019 | BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963 | Becton Dickinson & Company | Device | Class II | 8 |
| 9 May 2019 | Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. | Abbott Laboratories | Device | Class II | 1 |
| 3 May 2019 | Accu-Chek Connect Diabetes Management App | Roche Diabetes Care, Inc. | Device | Class II | 1 |
| 2 May 2019 | CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C | Becton Dickinson & Company | Device | Class II | 1 |
| 1 May 2019 | B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032 | B. Braun Medical, Inc. | Device | Class I | 1 |
| 24 Apr 2019 | PICC Line Accessory Kit CVI4285 | Centurion Medical Products Corporation | Device | Class II | 33 |
| 21 Mar 2019 | Rifton TRAM Standard Base, SKU K310, powered lift device | Community Products, LLC | Device | Class II | 3 |
| 19 Mar 2019 | AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems. | GE Healthcare, LLC | Device | Class II | 1 |
| 15 Mar 2019 | SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use | Name withheld | Device | Class I | 191 |
| 31 Jan 2019 | Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the number of liners and lids purchased in one… | Medline Industries Inc | Device | Class II | 1 |
| 21 Dec 2018 | DigitalDiagnost C50, Stationary X-ray System | Philips Healthcare | Device | Class II | 1 |
| 10 Dec 2018 | Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. Event 83383 | Leica Biosystems Imaging, Inc. | Device | Class II | 1 |
| 13 Nov 2018 | Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771 Event 83735 | Name withheld | Device | Class II | 1 |
| 30 Oct 2018 | Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944 Event 83701 | Horiba Instruments Incorporated | Device | Class II | 1 |
| 26 Oct 2018 | Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409 | Merit Medical Systems, Inc. | Device | Class II | 2 |
| 15 Oct 2018 | Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS). Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000… | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 10 Oct 2018 | L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 5 Oct 2018 | Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat… | Ohmeda Medical | Device | Class II | 1 |
| 21 Sep 2018 | SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and… | The Metrix Company | Device | Class II | 8 |
| 18 Sep 2018 | The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the… | Beckman Coulter Inc. | Device | Class II | 1 |
| 7 Sep 2018 | V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of… Event 83648 | Name withheld | Device | Class II | 1 |
| 7 Sep 2018 | APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product, | Abbott Laboratories, Inc | Device | Class II | 1 |
| 24 Aug 2018 | Beckman Coulter Lipase, REF OSR6130 and OSR6230. | Beckman Coulter Inc. | Device | Class II | 2 |
| 24 Aug 2018 | TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA. | TriMed Inc. | Device | Class II | 1 |
| 8 Aug 2018 | ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing… | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 8 Aug 2018 | Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 | Philips North America LLC | Device | Class II | 1 |
| 7 Aug 2018 | ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 1 Aug 2018 | Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump. | ICU Medical Inc | Device | Class II | 1 |
| 24 Jul 2018 | YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm) Catalog Numbers 7601-03512, 7601-03514,… | K2M, Inc | Device | Class II | 1 |
| 7 Dec 2017 | Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX. | Helena Laboratories, Corp. | Device | Class II | 1 |
| 29 Oct 2017 | OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036 Event 83902 | Xintec Corp | Device | Class III | 1 |
| 21 Jul 2017 | SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. | Helena Laboratories, Corp. | Device | Class II | 1 |
| 12 Jun 2017 | Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose… | Roche Diabetes Care, Inc. | Device | Class II | 2 |
| 2 Dec 2016 | K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine them with non-K2M navigation systems as part of their standard surgical technique. | K2M, Inc | Device | Class II | 1 |
| 12 Jul 2016 | Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and… Event 83381 | ELITech Group B.V. | Device | Class III | 1 |
| 18 Jan 2016 | V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse… Event 83607 | Name withheld | Device | Class II | 1 |
| 10 Jan 2012 | Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use | Name withheld | Device | Class II | 5 |