| 17 May 2018 | My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3. | Lupin Pharmaceuticals Inc. | Drug | Class II | 2 |
| 16 May 2018 | screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8005. | Ideaz Llc | Drug | Class II | 2 |
| 16 May 2018 | Nature's Only Choice B17 BITTER RAW APRICOT EXTRACT AMYGDALIN Dietary Supplement 100 Capsules (80073) | Nature's Only Choice | Food | Class II | 1 |
| 14 May 2018 | Gluten Free Chunky Chocolate Product, 20051, Size: 2.0 oz, Case Pack: 168, Net Wt: 21 LBS, UPC 1009606720051 (80098) | Michael's Bakery Products, LLC | Food | Class I | 1 |
| 11 May 2018 | Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010 | L. Perrigo Company | Drug | Class II | 1 |
| 9 May 2018 | Raley's Peanut Butter Brownies 6 Ct.; NET WT: 16 oz. 1 lb. UPC: 46567-61806 (80077) | Individual firm, name withheld | Food | Class III | 1 |
| 8 May 2018 | Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4 | Apotex Inc. | Drug | Class I | 2 |
| 7 May 2018 | Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02 (80049) | Perrigo New York | Drug | Class II | 1 |
| 7 May 2018 | Great Value Gluten Free Tomato Condensed Soup, 10.5 oz, Number 1 Can, Two formats shipped: 8 cans per tray and 12 cans per tray (80055) | Morgan Foods, Inc. | Food | Class I | 1 |
| 4 May 2018 | Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 4 May 2018 | Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186. | Noven Pharmaceuticals, Inc. | Drug | Class II | 2 |
| 4 May 2018 | T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT | Milbar Laboratories, Inc. | Drug | Class III | 2 |
| 4 May 2018 | B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA | Milbar Laboratories, Inc. | Drug | Class II | 4 |
| 2 May 2018 | smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 2 May 2018 | Soozie s Doozies Sugar Cinnamon Snickerdoodle Cookie Dough, 16 ounce, plastic pouch, 6 pouches per case (80035) | National Foodworks Services | Food | Class II | 1 |
| 2 May 2018 | Acadica Kratom: Red Suma 250g bags | Badger Botanicals LLC | Food | Class I | 4 |
| 2 May 2018 | Hot Dog Buns | Flowers Bakery Of Montgomery LLC | Food | Class I | 2 |
| 1 May 2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops. | TP Orthodontics, Inc. | Device | Class II | 13 |
| 1 May 2018 | Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20. | AuroMedics Pharma LLC | Drug | Class I | 1 |
| 1 May 2018 | Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30 | AuroMedics Pharma LLC | Drug | Class I | 1 |
| 1 May 2018 | Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20 | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class II | 2 |
| 1 May 2018 | Bob's Red Mill 100% Whole Wheat Bread Mix, Item 1674C194, packaged in flexible packaging bag, 4 bags to a cardboard case, each bag weighs 19 oz. The UPC is 0 39978 00667 7. The label on the FRONT side of a package is read in parts: "***Bob's Red Mill ***100% WHOLE WHEAT BREAD MIX***". The label on the BACK side of a… | Bob's Red Mill Natural Foods, Inc. | Food | Class II | 1 |
| 30 Apr 2018 | Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30) | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 30 Apr 2018 | PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22 | Mylan Pharmaceuticals Inc. | Drug | Class II | 3 |
| 30 Apr 2018 | STONEWALL KITCHEN Basil Pesto Aioli Net Weight Net 10.25 oz. UPC: 7 11381 03060 8. Product is incorrectly labeled as Basil Pesto, Net Weight 8 oz. | Stonewall Kitchen, LLC | Food | Class I | 1 |
| 27 Apr 2018 | Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01 | Sanofi-Aventis U.S. LLC | Drug | Class II | 1 |
| 27 Apr 2018 | Parade Salsa Hot/Picante NET WT/PESO NETO 24 OZ (1 LB 8 OZ) 680g, UPC: 0 50700 08883 9 | Giovanni Food Company, Inc. | Food | Class II | 3 |
| 27 Apr 2018 | Vans gluten free Original 6 WAFFLES NET WT 9 OZ (255g) INGREDIENTS:***VAN'S GLUTEN FREE MIX (BROWN RICE FLOUR, POTATO STARCH, RICE FLOUR, SOY FLOUR),***RICE FLOUR,***SUNFLOWER AND/OR SOY LECITHIN***CONTAINS: SOY DISTRIBUTED BY: VAN'S INTERNATIONAL FOODS SAN DIEGO, CA 92154 UPC 0 89947 30206 4 (79999) | Tyson Foods Discovery Center | Food | Class I | 1 |
| 26 Apr 2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples… | Individual firm, name withheld | Device | Class II | 40 |
| 26 Apr 2018 | Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02 | Sun Pharmaceutical Industries, Inc. | Drug | Class III | 1 |
| 26 Apr 2018 | Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL (80005) | Coast Quality Pharmacy LLC | Drug | Class II | 1 |
| 26 Apr 2018 | Bombay Kitchen Bhavnagri Mix, packaged in a 19 oz., clear bag, UPC: 808550110206 (79989) | Ethnic Foods, Inc. d/b/a Bombay Kitchen Foods | Food | Class I | 1 |
| 25 Apr 2018 | Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. | Baxter Healthcare Corporation | Device | Class II | 4 |
| 25 Apr 2018 | Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output. | ConvaTec, Inc | Device | Class II | 1 |
| 25 Apr 2018 | Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections. (79962) | Conseal International, Inc. | Device | Class II | 1 |
| 25 Apr 2018 | Protein key brand Protein Meals varieties, 2.5 lb plastic container and 400 g plastic container, Varieties: Anti-Aging Plain | Wysong Corporation | Food | Class II | 25 |
| 25 Apr 2018 | Zoi Mixed Berry Greek Yogurt Parfait, 9 oz. clear plastic cup, covered with a clear plastic snap-on lid. UPC 8 17203 02172 1. The label is read in parts: "***Honey Greek Yogurt Willamette Valley Mixed Berries Honey Almond Granola Parfait***KEEP REFRIGERATED***INGREDIENTS: HONEY GREEK YOGURT***HONEY ALMOND GRANOLA… (79981) | A G Specialty Foods, Inc. | Food | Class II | 1 |
| 24 Apr 2018 | Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or… | Baxter Healthcare Corporation | Device | Class II | 5 |
| 24 Apr 2018 | Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01 | Mylan Pharmaceuticals Inc. | Drug | Class II | 2 |
| 24 Apr 2018 | Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc | Vitalab Pharmacy, Inc | Drug | Class II | 6 |
| 24 Apr 2018 | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01 | Mylan Pharmaceuticals Inc. | Drug | Class II | 2 |
| 24 Apr 2018 | Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia, PA. Pckgd by PreScript Pharm. Inc. Pleasanton, CA 94566. NC 00527-1382-01, Bar Code 0639-30-176 | Prescript Pharmaceuticals, Inc. | Drug | Class II | 5 |
| 24 Apr 2018 | Lean Pro 8 Vanilla 2,268g (5lb) Tub | Labrada Nutrition, Inc | Food | Class I | 3 |
| 24 Apr 2018 | Arugula Microgreens, Greenbelt Microgreens brand, net wt. 75 gram. Product is packaged in a clear plastic clam shell container. UPC 8 90082 00012 4 | Greenbelt Greenhouse Ltd | Food | Class I | 7 |
| 23 Apr 2018 | DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical | DeRoyal Industries Inc | Device | Class II | 1 |
| 23 Apr 2018 | Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01 (79980) | Individual firm, name withheld | Drug | Class II | 1 |
| 23 Apr 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10 | Mckesson Packaging Services | Drug | Class III | 3 |
| 23 Apr 2018 | Budget $aver Sugar Free Twin Pops Net Contents 28.2 FL OZ | Ziegenfelder Company, Inc. | Food | Class II | 2 |
| 21 Apr 2018 | Great Value Organic Ground Flax Seed, Net Wt. 16 oz. (1 LB) 454g. UPC 78742-14161, and Net Wt. 32 oz. (2 LB) 907g, UPC 78742-14165 Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716 (79935) | HEALTHY FOOD INGREDIENTS | Food | Class II | 1 |
| 20 Apr 2018 | Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz | LivaNova USA | Device | Class II | 1 |
| 20 Apr 2018 | Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06. | Exela Pharma Sciences LLC | Drug | Class II | 1 |
| 20 Apr 2018 | Eden's Ethnos Bulk Kratom 25 powder kilogram bag Also called K. Bali Supreme, K Maeng Da Supreme, K Green Vein, Green Maeng Da, K Red Maeng Da, K Red Bali, K Green Bali Distributed by Eden Ethnos LLC, Carlsbad, CA 92010 (79951) | Eden's Ethnos, LLC | Food | Class I | 1 |
| 19 Apr 2018 | Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05 | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 1 |
| 19 Apr 2018 | Happy Harvest Leaf Spinach; Net Wt. 13.5 oz (383g); Ingredients: Spinach, Water, Salt. Distributed by Aldi Inc. Batavia, IL 60510; Product of USA; Manufactured In A Facility That Processes Peanuts and Soy. May Contain Peanuts and Soy. Packaged in a steel 2-piece can. | Mccall Farms Inc | Food | Class I | 1 |
| 18 Apr 2018 | Whole Wheat Chocolate Animal Cookies; 5 oz. pouch, 5 lb. Corporate bags UPC: 8 58950 00508 6 Ingredients: Whole Wheat Flour, Unbleached Enriched Wheat Flour (niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid). soluble Corn Prebiotic Fiber, Granulated sugar, Expeller Expressed Canola Oil, cocoa… | NatureBox, Inc. | Food | Class II | 1 |
| 18 Apr 2018 | Asian Best, Tamarind Candy Hot Flavor Net Weight: 4 oz. Units Per Carton: 72 units | Eastland Food Corporation | Food | Class II | 2 |
| 18 Apr 2018 | Smoked Salmon Spread 5 lb. bulk units; Simply Superior Smoked Salmon Spread 5 oz units; and Morey s Smoked Salmon Spread 6 oz units; Deli Cups, Deli Tubs (79892) | Superior Foods Company | Food | Class I | 1 |
| 18 Apr 2018 | Stuffed FOODS Edamame Burger, MFG ITEM # 06100 UPC: 108500821003752 3 - 3lb plastic bags in box | Stuffed Foods LLC | Food | Class II | 1 |
| 18 Apr 2018 | Mitragyna Speciosa Leaf Powder Red Vein Sumatra and Mitragyna Speciosa Leaf Powder Red Vein Bali, sold under the brand name Herbal-Salvation.com. The powder is packaged in kraft paper, foil-lined heat sealed pouches and sold in 25g, 100g, 250g, and 1000g. The product label is read in parts:… | Viable Solutions, LLC | Food | Class I | 3 |
| 17 Apr 2018 | Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45 (79820) | Rhodes Pharmaceuticals, L.P. | Drug | Class III | 1 |
| 17 Apr 2018 | Hilltop Hearth Self-Rising Flour, Katy s Kitchen Self-Rising Flour, Springwell A1 Flour all packaged in 50 pound paper bags | Shawnee Milling Company, Inc. | Food | Class II | 1 |
| 16 Apr 2018 | AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1.… (79889) | Individual firm, name withheld | Device | Class II | 1 |
| 16 Apr 2018 | Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral… | Cook Inc. | Device | Class II | 1 |
| 16 Apr 2018 | ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee | DePuy Orthopaedics, Inc. | Device | Class II | 2 |
| 16 Apr 2018 | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature. | Bard Peripheral Vascular Inc | Device | Class II | 2 |
| 16 Apr 2018 | Traditional Medicinals Throat Coat Lemon Echinacea; Lemon Echinacea, Naturally Caffeine Free Herbal Tea' 16 wrapped tea bags - Herbal Supplement NET WT 1.13 oz. (32 g) UPC: 32917-00159 | Traditional Medicinals Inc | Food | Class II | 2 |
| 16 Apr 2018 | Southwestern Gourmet Butter Popcorn Grand Canyon Foods, Phoenix, AZ | Grand Canyon Foods International LLC. | Food | Class II | 2 |
| 16 Apr 2018 | Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579 | Grato Holdings, Inc. | Food | Class II | 4 |
| 14 Apr 2018 | Shelled Eggs, Extra Large 18pk sold under the brand names of Publix UPC 0 41415 00966 0 & Sunups UPC 0 28621 36398 4 (79862) | Cal Maine Foods | Food | Class I | 1 |
| 14 Apr 2018 | eataly artichoke spread, net wt. 7oz 200g, UPC 612067 (79904) | EATALY NY, LLC (DUTY ONLY) | Food | Class I | 1 |
| 13 Apr 2018 | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. | Coltene Whaledent Inc | Device | Class II | 1 |
| 13 Apr 2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-331-04, UPC 364980331043 | Lyne Laboratories, Inc. | Drug | Class II | 3 |
| 13 Apr 2018 | OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10 (79976) | Septodont Inc. | Drug | Class III | 1 |
| 13 Apr 2018 | Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA (79846) | Boiron Inc. | Drug | Class III | 1 |
| 13 Apr 2018 | Formagere de la Brie brand, l 'Explorateur, soft ripened cheese made from pasteurized milk, product comes in a 250g (8.8 oz), clear plastic package marked with lot # on the bottom, with UPC: 3 390010 004080. (79859) | Cheezwhse/Com | Food | Class I | 1 |
| 13 Apr 2018 | Shell Eggs packaged in quantities and styles of pack (plastic and pulp cartons, flats, and boxes) (79839) | ROSE ACRE FARM | Food | Class I | 1 |
| 13 Apr 2018 | Market District Roasted Salted Cashews Whole Fancy Net WT 26 oz (1LB 10 OZ) 737g. Ingredients: Cashews, Canola and/or Peanut Oil, Salt. Distributed by Giant Eagle, Inc. Pittsburgh, PA 15238-2809 UPC 0 30034 10382 8 | Kanan Enterprises, Inc. | Food | Class II | 1 |
| 12 Apr 2018 | Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128 (79852) | AMA Wholesale | Drug | Class I | 1 |
| 11 Apr 2018 | NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the… (79884) | Ninepoint Medical Inc. | Device | Class II | 1 |
| 11 Apr 2018 | Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10 | Premier Pharmacy Labs Inc | Drug | Class II | 4 |
| 11 Apr 2018 | Sugarfina Platinum Bling Ring; Product SKU No. R-1790 UPC: 840278116139 Net W. 21g ().7 oz.) Sculpted from dark chocolate, these interlocking rings have a thin sugar shell brushed with edible silver: Ingredients: Dark Chocolate (cocoa, sugar, cocoa butter, soy lecithin (an emulsifier_ sugar, Dextrose, gum Arabic,… | Sugarfina, LLC | Food | Class III | 1 |
| 11 Apr 2018 | Hot Smoked Keta Beergarden Salmon, Seabear brand, Reduced Oxygen Packaging, Net Wt. 4oz (113g). No UPC. | Seabear Company | Food | Class I | 2 |
| 11 Apr 2018 | Four J Charred Tomato & Basil Sauce 24 oz packaged in a glass jar, 6 units per case | Riba Foods Inc | Food | Class II | 1 |
| 10 Apr 2018 | BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and… (79972) | Bard Brachytherapy, Inc. | Device | Class II | 1 |
| 10 Apr 2018 | Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821. | Pharmalucence, Inc. | Drug | Class II | 1 |
| 10 Apr 2018 | Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 | Aidarex Pharmaceuticals LLC | Drug | Class III | 1 |
| 10 Apr 2018 | All dietary supplements manufactured and distributed by Riddhi USA Inc. (79712) | Riddhi USA Inc. | Food | Class II | 1 |
| 10 Apr 2018 | Cinnamon Sugar Cookie, Brand name Columbia Gorge Gluten Free. Packaged in a plastic bag for wholesale purposes. The product is received frozen and baked in house for individual serving. NO UPC (79804) | Individual firm, name withheld | Food | Class III | 1 |
| 9 Apr 2018 | smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II 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 with an… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 9 Apr 2018 | EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control… | Covidien LLC | Device | Class II | 2 |
| 9 Apr 2018 | Explorateur French Triple Cr¿me cheese (under the names Explorateur, Explorateur French Triple Cr¿me Cheese and Explorateur Triple Cr¿me French Cheese) which were both cut and packaged in clear plastic wrap, as well as sold in branded 8 oz. packages | Whole Foods Market | Food | Class I | 1 |
| 7 Apr 2018 | DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate. (79878) | Rockwell Medical, Inc | Device | Class II | 1 |
| 7 Apr 2018 | Chocolate Peanut Butter Cup Ice Cream, packaged in a 16 oz. cardboard container, UPC 082086444688 | Stewart's Shops Corp. | Food | Class III | 1 |
| 6 Apr 2018 | EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY | MHC Medical Products LLC | Device | Class II | 2 |
| 6 Apr 2018 | ITALIAN ROSE GARLIC SPREAD, Gluten Free, NET WT. 35 LB (16 kg), www.italian-rose.com, Riviera Beach, FL 33404 (79823) | Italian Rose Garlic Products, LLC | Food | Class III | 1 |
| 6 Apr 2018 | Raw Form Organics Maeng Da Kratom Emerald Green; 150 capsule and 300 capsule plastic bottles; Manufactured for Raw Form Organics, Las Vegas, NV 89118 by Triangle Pharmanaturals, LLC, Las Vegas, NV 89119 | TRIANGLE PHARMANATURALS LLC | Food | Class I | 26 |
| 5 Apr 2018 | Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 5 Apr 2018 | Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions… | Individual firm, name withheld | Device | Class II | 3 |
| 5 Apr 2018 | Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure. | Abbott | Device | Class I | 1 |
| 5 Apr 2018 | CYANOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr., Ste C Bioloxi, MS 39532 | Coastal Meds, LLC. | Drug | Class II | 10 |
| 4 Apr 2018 | CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances).… | Maquet Cardiopulmonary Ag | Device | Class II | 1 |
| 4 Apr 2018 | CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood. (79872) | Individual firm, name withheld | Device | Class II | 1 |
| 4 Apr 2018 | IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use. | Deerfield Imaging, Inc. | Device | Class II | 1 |
| 3 Apr 2018 | Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 3 Apr 2018 | Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if… | Baxter Healthcare Corporation | Device | Class II | 5 |
| 3 Apr 2018 | Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02); Humira Pen Psor Kit b.) 40 mg/0.8 mL (NDC 00074-4339-07) 28 day supply, Rx Only, | Kroger Specialty Pharmacy, Inc. | Drug | Class II | 67 |
| 2 Apr 2018 | Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623 | Synthes (USA) Products LLC | Device | Class II | 2 |
| 2 Apr 2018 | Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments. | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 30 Mar 2018 | Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta. | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 30 Mar 2018 | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. | Smith & Nephew, Inc. | Device | Class II | 4 |
| 30 Mar 2018 | AdvoCare Nighttime Recovery Amino Acid and Herbal Dietary Supplement Product code, P3201 | AdvoCare International, LP | Food | Class II | 2 |
| 29 Mar 2018 | iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY… | Beckman Coulter Inc. | Device | Class II | 1 |
| 29 Mar 2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular… | Cook Inc. | Device | Class II | 6 |
| 29 Mar 2018 | Chocolate Sea Salt Probiotic Granola, Purely Elizabeth, 8oz, PET/LLDPE Pouch, 6 units/case, (79837) | Individual firm, name withheld | Food | Class II | 1 |
| 28 Mar 2018 | Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity. | Ace Surgical Supply Co., Inc. | Device | Class II | 1 |
| 28 Mar 2018 | Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee. | Zimmer Biomet, Inc. | Device | Class II | 6 |
| 28 Mar 2018 | Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in… | Cardinal Health 200, LLC | Device | Class II | 1 |
| 28 Mar 2018 | Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and… | Draegar Medical Systems, Inc. | Device | Class II | 1 |
| 28 Mar 2018 | Ignite High Endurance Pre-Workout Supplement with Caffeine, brand Back to Health, Net wt. 1 lb. UPC 8 01650 01540 2. Ignite High Endurance Pre-Workout Supplement with CAFFEINE, brand Muscle Sports & Nutrition (MSN), Net wt. 1 lb. UPC 8 01650 01540 2 and UPC 8 01650 01541 9. | Independent Nutrition, Inc. | Food | Class I | 5 |
| 27 Mar 2018 | Syngo.Via VB20A model 1049610 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 27 Mar 2018 | Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51 | AuroMedics Pharma LLC | Drug | Class II | 7 |
| 27 Mar 2018 | Amys Gluten and Dairy Free Bean Rice Burrito 6oz UPC: 42272003525 Target item number: 270-2-1391 | Target Corporation | Food | Class II | 199 |
| 26 Mar 2018 | AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological… | Tornier, Inc | Device | Class II | 1 |
| 26 Mar 2018 | M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00 | Zimmer Biomet, Inc. | Device | Class II | 12 |
| 26 Mar 2018 | MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients. | Philips Medical Systems Nederlands | Device | Class II | 7 |
| 26 Mar 2018 | BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. MICroSTREP plus panels are designed for use in determining… | Beckman Coulter Inc. | Device | Class II | 1 |
| 26 Mar 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT | Ethicon Endo-Surgery Inc | Device | Class II | 5 |
| 26 Mar 2018 | ELA ADA (JACK FRUIT), UPC: 8 70400 00085 2 | Maharaja Food Importers, Inc. | Food | Class II | 6 |
| 25 Mar 2018 | Decorated (iced holiday cookies sold from self service cookie displays - cookies in the shape of eggs, bunnies and chicks. The signage by the displays do not declare egg as an ingredient of the cookies. Cookies are received in a 9 lb. bag Correct Ingredients: Unbleached, Unbromated Wheat Flour (Wheat flour, malted… | Whole Foods Market | Food | Class I | 1 |
| 23 Mar 2018 | Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 23 Mar 2018 | Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W | Straumann Manufacturing, Inc. | Device | Class II | 6 |
| 22 Mar 2018 | Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. | Volcano Corporation | Device | Class II | 1 |
| 21 Mar 2018 | First Step Endoscopic Cleaning Pad, 100ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-3 | Individual firm, name withheld | Device | Class II | 6 |
| 20 Mar 2018 | BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342) | Becton Dickinson & Company | Device | Class II | 3 |
| 20 Mar 2018 | Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002) | Epic Extremity, LLC | Device | Class II | 2 |
| 20 Mar 2018 | Bloody Hell Mary, HOT, Kitchen By The Sea, From the Beach House, Net Wt. 32 oz. (.9L), Low Sodium | Kitchen By The Sea | Food | Class I | 2 |
| 20 Mar 2018 | Dragon Ultra Ehanced Indo Extract 4-ct x 500 mg capsules in pouches. | Maya Distribution, LLC | Food | Class I | 4 |
| 19 Mar 2018 | Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants. | Synthes, Inc. | Device | Class II | 1 |
| 19 Mar 2018 | Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region | Teleflex Medical Europe Ltd | Device | Class II | 1 |
| 16 Mar 2018 | Nxtgen Botanicals, Maeng Da Kratom, Dietary Supplement, 70 capsules (79794) | NGB, Corp | Food | Class I | 1 |
| 16 Mar 2018 | Izzy's Ice Cream, Maple Nut, One Pint (473 ml), UPC 51115-00106. Izzy's Ice Cream, 1100 2nd Street S., Minneapolis, MN 55415. (79569) | Izzy's Ice Cream, LLC | Food | Class II | 1 |
| 15 Mar 2018 | All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is… | Bayer HealthCare Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 15 Mar 2018 | RALEY'S PISTACHIO GELATO; 10.58 oz. plastic tub UPC: 46567-02382 Ingredients: rehydrated skimmed milk, sugar, coconut oil, glucose syrup, pure pistachio paste, whole roasted pistachios, milk proteins, mono and diglycerides of fatty acids (emulsifiers), sodium alginate and carob bean gum (thickeners), artificial… (79736) | Individual firm, name withheld | Food | Class III | 1 |
| 14 Mar 2018 | FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191. | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 14 Mar 2018 | Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system. | Accelerate Diagnostics Inc | Device | Class II | 1 |
| 14 Mar 2018 | Philips HeartStart FRx AED. | Philips Electronics North America Corp. | Device | Class II | 2 |
| 14 Mar 2018 | ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit… | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 14 Mar 2018 | PTS Panels¿ CHOL+GLU Test Strips (REF 1765) | Polymer Technology Systems, Inc. | Device | Class II | 1 |
| 14 Mar 2018 | Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic,… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 14 Mar 2018 | PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its… | Invivo Corporation | Device | Class II | 1 |
| 13 Mar 2018 | Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring… | LivaNova USA | Device | Class II | 2 |
| 13 Mar 2018 | Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be… | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 13 Mar 2018 | Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket | Keystone Dental Inc | Device | Class II | 1 |
| 13 Mar 2018 | Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box. (79591) | Individual firm, name withheld | Device | Class II | 1 |
| 12 Mar 2018 | Trident Endoscopic Ultrasonic Biopsy Needle (FNB) | Micro-Tech (Nanjing) Co., Ltd. | Device | Class II | 2 |
| 12 Mar 2018 | 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of… | CooperSurgical, Inc. | Device | Class II | 1 |
| 12 Mar 2018 | Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults. | Stryker GmbH | Device | Class II | 1 |
| 12 Mar 2018 | Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483 | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 2 |
| 12 Mar 2018 | Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151 | CooperSurgical, Inc. | Device | Class II | 1 |
| 11 Mar 2018 | RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery. | Richard Wolf GmbH | Device | Class II | 1 |
| 9 Mar 2018 | 6376 M-1 Cot Fastener, catalog no. 6376000000 | Stryker Medical Division of Stryker Corporation | Device | Class II | 2 |
| 7 Mar 2018 | Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device. | Ethicon, Inc. | Device | Class II | 1 |
| 6 Mar 2018 | Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions | Integra LifeSciences Corp. | Device | Class II | 1 |
| 5 Mar 2018 | Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters. | Synthes, Inc. | Device | Class II | 1 |
| 5 Mar 2018 | ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 5 Mar 2018 | Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes. | Tosoh Bioscience Inc | Device | Class II | 4 |
| 2 Mar 2018 | BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro… | Beckman Coulter Inc. | Device | Class II | 1 |
| 2 Mar 2018 | Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as… | Randox Laboratories Ltd. | Device | Class II | 1 |
| 2 Mar 2018 | BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829 | Becton Dickinson & Co. | Device | Class III | 2 |
| 1 Mar 2018 | Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia… | Draeger Medical, Inc. | Device | Class I | 4 |
| 28 Feb 2018 | Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368 | Zimmer GmbH | Device | Class II | 2 |
| 28 Feb 2018 | PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system. | Vygon U.S.A. | Device | Class II | 8 |
| 27 Feb 2018 | AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or… | Radiometer Medical ApS | Device | Class II | 1 |
| 26 Feb 2018 | Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549 | Beaver-Visitec International Inc. | Device | Class II | 1 |
| 26 Feb 2018 | Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 3 |
| 26 Feb 2018 | WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures. | Beaver-Visitec International Inc. | Device | Class II | 1 |
| 26 Feb 2018 | MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke… | Micro Therapeutics Inc, Dba Ev3 Neurovascular | Device | Class I | 1 |
| 23 Feb 2018 | Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material. (79662) | Individual firm, name withheld | Device | Class II | 1 |
| 23 Feb 2018 | T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 11 |
| 22 Feb 2018 | cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total… | Roche Diagnostics Corporation | Device | Class II | 4 |
| 21 Feb 2018 | ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests) | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 21 Feb 2018 | clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in… | CooperVision Inc. | Device | Class III | 4 |
| 21 Feb 2018 | Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 21 Feb 2018 | Munk Pack PROTEIN COOKIE DOUBLE DARK CHOCOLATE NET WT 2.96oz (84g); UPC: 853787005368 | MUNK PACK INC | Food | Class II | 2 |
| 20 Feb 2018 | Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.… | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 15 Feb 2018 | Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment. | Transonic Systems Inc | Device | Class II | 1 |
| 15 Feb 2018 | SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. | Siemens Medical Solutions USA, Inc | Device | Class II | 15 |
| 13 Feb 2018 | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System (79645) | Individual firm, name withheld | Device | Class II | 1 |
| 13 Feb 2018 | Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse. (79764) | Michigan Instruments, Inc. | Device | Class III | 1 |
| 12 Feb 2018 | Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site. | Boston Scientific Corporation | Device | Class II | 11 |
| 8 Feb 2018 | Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test. | Life Technologies Corporation | Device | Class II | 1 |
| 8 Feb 2018 | POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362 | Bard Peripheral Vascular Inc | Device | Class II | 14 |
| 5 Feb 2018 | ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use. | Individual firm, name withheld | Device | Class II | 3 |
| 5 Feb 2018 | DIABEATIC Chocolate Berry Crunch bar NET WT 1.4 oz (42g)Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00423 3 | eBars | Food | Class I | 13 |
| 31 Jan 2018 | StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044 | Cook Inc. | Device | Class II | 7 |
| 30 Jan 2018 | Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function. | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 30 Jan 2018 | Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 26 Jan 2018 | Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 26 Jan 2018 | Proteus 235, ProteusPLUS or Proteus ONE produces 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 |
| 19 Jan 2018 | Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system. | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 12 Jan 2018 | Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 11 Jan 2018 | Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd.,… | Time-Cap Laboratories, Inc. | Drug | Class II | 11 |
| 5 Jan 2018 | Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital. | ICU Medical, Inc. | Device | Class II | 1 |
| 2 Jan 2018 | Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test | Roche Diagnostics Corporation | Device | Class II | 1 |
| 2 Jan 2018 | Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 24 |
| 28 Dec 2017 | HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622 | Southwest Technologies Inc | Device | Class II | 3 |
| 22 Dec 2017 | LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries. | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 1 |
| 20 Dec 2017 | The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 19 Dec 2017 | Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis.… | Nipro Medical Corporation | Device | Class II | 1 |
| 15 Dec 2017 | Alere iScreen Dx Urine Drug Screen Card | Ameditech Inc | Device | Class III | 1 |
| 14 Dec 2017 | ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem. | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 14 Dec 2017 | Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase) | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 11 Dec 2017 | Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 | Smith & Nephew, Inc. | Device | Class II | 1 |
| 8 Dec 2017 | Widefield OCT software feature for the Spectralis HRA+OCT and variants (79453) | Individual firm, name withheld | Device | Class II | 1 |
| 8 Dec 2017 | MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. (79439) | Hitachi Ltd., Medical System Operations Group | Device | Class II | 1 |
| 4 Dec 2017 | iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as… | Beckman Coulter Inc. | Device | Class II | 1 |
| 1 Dec 2017 | RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements. | Mako Surgical Corporation | Device | Class II | 1 |
| 17 Nov 2017 | Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. | PerkinElmer Life and Analytical Sciences, Wallac, OY | Device | Class II | 1 |
| 16 Nov 2017 | ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094 | GETINGE US SALES LLC | Device | Class II | 1 |
| 13 Nov 2017 | 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10. | Fresenius Medical Care Renal Therapies Group, LLC | Drug | Class II | 1 |
| 8 Nov 2017 | SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 6 Nov 2017 | Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue. | Southmedic, Inc. | Device | Class II | 1 |
| 2 Nov 2017 | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680… | PerkinElmer Life and Analytical Sciences, Wallac, OY | Device | Class II | 1 |
| 1 Nov 2017 | ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical… | Microline Surgical, Inc. | Device | Class II | 2 |
| 19 Oct 2017 | BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430 | Datascope Corporation | Device | Class II | 28 |
| 10 Oct 2017 | Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition. (79669) | Crimson Trace Corporation | Device | Class II | 1 |
| 18 Aug 2017 | TCC-EZ, Total Contact Cast System, Model No. TCC2-4051 | Integra LifeSciences Corp. | Device | Class II | 1 |
| 7 Aug 2017 | Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis. | Zimmer Biomet, Inc. | Device | Class II | 4 |
| 7 Jul 2017 | Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use. (79858) | Ondamed Inc | Device | Class II | 1 |
| 3 Jul 2017 | Beijing Syntech Laser Diode Laser surgical lasers | Beijing Syntech Laser Co., Ltd | Device | Class II | 8 |
| 29 Jun 2017 | ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories) | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 17 |
| 10 Jun 2017 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) | Kelyniam Global, Inc. | Device | Class II | 4 |
| 27 Apr 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. | Vyaire Medical | Device | Class I | 35 |
| 13 Apr 2017 | Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case | Parker Laboratories, Inc. | Device | Class II | 1 |
| 4 Apr 2017 | MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the… | Diagnostic Hybrids, Inc. | Device | Class II | 1 |
| 15 Feb 2017 | Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults. (79830) | IntroMedic Co., Ltd. | Device | Class II | 1 |
| 15 Nov 2016 | ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL. | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 26 Oct 2016 | Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum. | Diagnostic Hybrids, Inc. | Device | Class III | 1 |
| 14 Jul 2016 | MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum. | Diagnostic Hybrids, Inc. | Device | Class II | 1 |
| 3 Nov 2015 | MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement… | Diagnostic Hybrids, Inc. | Device | Class III | 3 |
| 14 Dec 2012 | True Taste Seafood Hot Smoked Lake Herring; Ingredients: Lake Herring, salt, original smoke; To be weighed at point of sale - approximately 3/4 lb. | True Taste, LLC. | Food | Class I | 7 |