| 10 Dec 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 6 Dec 2019 | Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80 | Lannett Company, Inc. | Drug | Class I | 1 |
| 6 Dec 2019 | Tailor Cut Produce Inc., Honeydew Chunk, 2 1 gallon tubs per case. | Tailor Cut Produce Inc. | Food | Class I | 7 |
| 6 Dec 2019 | Truly Good Foods SOUTH OF THE BORDER nut mix NET CT/WT: 25lb box, CONTAINS: PEANUTS, MILK, AND WHEAT. Distributed by Truly Good Foods, Charlotte, N.C. 28273 UPC 0 94184 11019 8 | Tropical Nut & Fruit Company | Food | Class II | 1 |
| 4 Dec 2019 | Lalamilo Farms Tropical Dreams Hawaiian Ice Cream - Strawberry Cheesecake. Sold in 3 gallon tubs, 1.5 gallon tubs, 5 L tubs, 8 oz. cups. Ingredients: Cream, Nonfat Milk, Sugar, Corn Syrup, Water, High Fructose Corn Syrup, Cream Cheese Powder {Cream Cheese{milk, culture, salt, Carob Bean Gum, Enzyme}, Nonfat Milk],… (84432) | Edney and Sellers, Ltd. | Food | Class II | 1 |
| 4 Dec 2019 | Jolly Rancher product is hard candies, individually wrapped in flexible plastic wrap, and package in plastic bag. Net weight 2 oz or 4.5 oz. UPC on the 4.5 oz. bag: 7 09972 80101 0. The label of the retail bag is read in parts: INGREDIENTS: CORN SYRUP, SUGAR, CONTAINS 2% OR LESS OF, MALIC ACID, NATURAL AND ARTIFICIAL… | Werner Gourmet Meat Snacks, Inc. | Food | Class II | 1 |
| 3 Dec 2019 | Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console. | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 3 Dec 2019 | Onset Worldwide, Nitro-Milled Black Chia, Unit size: 50 lb Bulk (84446) | Onset Worldwide | Food | Class I | 1 |
| 3 Dec 2019 | GOURMET BAY Haddock with Seafood Stuffing; 6oz; SELL BY 05/26/21; LOT# 100457657; KEEP FROZEN; Cooking Instructions: Oven: Preheat oven to 400 degrees F. Place fish on a lined non-stick baking sheet. Bake for 15-20 minutes or until internal temperature reaches 165 degrees F. | Slade Gorton & Company, Inc. | Food | Class II | 3 |
| 2 Dec 2019 | Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals | Preferred Pharmaceuticals, Inc | Drug | Class II | 1 |
| 2 Dec 2019 | Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01. | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 2 Dec 2019 | Maple Bacon flavored Popcorn, packaged in poly lined bags, net wt. 7 oz. (198 g). No UPC code. | CornFusion Gourmet Popcorn, LLC | Food | Class II | 3 |
| 2 Dec 2019 | Tri-Color Coleslaw - Marketside brand; 16 oz. plastic bag, SKU 3117 Colorful Coleslaw/Salade de Chou - President's Choice Brand - (Canada only) 14 oz. plastic bag, SKU 3237 A blend of green and red cabbage and carrots. Marketside UPC: 6-81131-38748-4 President's Choice UPC: 0-60383222670 | Dole Fresh Vegetables Inc | Food | Class I | 1 |
| 27 Nov 2019 | 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10 | Pfizer Inc. | Drug | Class II | 1 |
| 27 Nov 2019 | CBI BG 2280/45025, 50 lb. package, 1 poly bag in cardboard box, 1140496 (84387) | Skidmore Sales & Distributing Co Inc | Food | Class II | 1 |
| 27 Nov 2019 | Hodgson Mill Unbleached All-Purpose White Wheat Flour 5 Lb bags 001042 Best By 10-01-2020 005517 Best By 10-02-2020 (84362) | Cell-nique Corp dba Living Harvest at Hudson River Foods | Food | Class II | 1 |
| 26 Nov 2019 | Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09 | SCA Pharmaceuticals, LLC | Drug | Class II | 1 |
| 25 Nov 2019 | Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20. | AuroMedics Pharma LLC | Drug | Class II | 1 |
| 25 Nov 2019 | VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771. | Apothecus Pharmaceutical Corp. | Drug | Class III | 1 |
| 25 Nov 2019 | Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 (84437) | OraLabs, Incorporated | Drug | Class II | 1 |
| 25 Nov 2019 | Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA | Medisca, Inc. | Drug | Class II | 1 |
| 22 Nov 2019 | Monaco Radiation Treatment Planning System (RTP) System | Elekta Inc | Device | Class II | 1 |
| 22 Nov 2019 | Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11). | Amneal Pharmaceuticals, Inc. | Drug | Class II | 5 |
| 22 Nov 2019 | Whole Foods Market Raspberry Cheesecake Italian Gelato 1 Pint (473mL) UPC 9948248024 packaged in a clear plastic container | Whole Foods Market | Food | Class II | 1 |
| 22 Nov 2019 | Tuna King 4 oz. and 6 oz. Tuna Steaks (frozen) Production date 06/13/2019 Expiration: 06/13/2021 4 oz. UPC 815838020645, lot 0058798; 6 oz. UPC 815838020652, lot 0058799 | Northern Fisheries Ltd. | Food | Class II | 3 |
| 21 Nov 2019 | DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP | DeRoyal Industries Inc | Device | Class II | 1 |
| 21 Nov 2019 | EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20, | Pacira Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 21 Nov 2019 | Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01 | Preferred Pharmaceuticals, Inc | Drug | Class II | 1 |
| 21 Nov 2019 | Frog Hollow Holiday Fruitcake Incorrect ingredients: Organic butter, organic flour, organic sugar, organic eggs, molasses, candied orange peel, rum, dried plums, organic dried peaches. Correct label: organic butter, organic flour, organic sugar, organic eggs, organic walnuts, molasses, candied orange peel, rum,… (84351) | Individual firm, name withheld | Food | Class II | 1 |
| 21 Nov 2019 | Nat Cashew Flavor Type, 11.34 kg in each 4.2 gallon blue HDPE jerri-can, UPC: 20355428593 | Givaudan Flavours Corp | Food | Class II | 4 |
| 20 Nov 2019 | Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05 | AuroMedics Pharma LLC | Drug | Class I | 2 |
| 20 Nov 2019 | Lamb Weston Grown In Idaho Crispy Hash Brown Dices, packaged in 28 ounce poly retail bags, 6 or 12 bags packaged in a master case. UPC: 0 43301 61170 4. The retail bag has the cooking instructions. Item #36003, Lamb Weston Grown in Idaho Crispy Hash Brown Dices, net wt. 21 lbs. master case. UPC 10043301611704. Item #… | Lamb Weston Inc | Food | Class II | 1 |
| 19 Nov 2019 | OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose… | Angiodynamics, Inc. | Device | Class II | 5 |
| 19 Nov 2019 | Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99 | AuroMedics Pharma LLC | Drug | Class II | 1 |
| 19 Nov 2019 | Onion Minced: 16-40 Mesh, Net Weight: 24/kg/52.91lbs, Manufacturing Date: May, 2019, Country of Origin: China, Manufactured for GH Imports Inc. (84347) | GH IMPORTS, INC | Food | Class II | 1 |
| 18 Nov 2019 | Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic | Southwest Technologies Inc | Device | Class II | 1 |
| 18 Nov 2019 | BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary… | Leica Microsystems, Inc. | Device | Class II | 1 |
| 18 Nov 2019 | Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator. | Boston Scientific Corporation | Device | Class II | 2 |
| 18 Nov 2019 | Honey Mama s Truffle Bar (Trader Joe's) is a honey cocoa bar, refrigerated, one bar is packaged in flexible film, flow wrapped, net weight 1.35 oz. UPC 8 54835 00415 9. There are 12 bars per display case and 6 cases per master case. The label is read in parts: "***Truffle ***HONEY MAMA'S HONEY-COCOA BAR ***PALEO***… (84323) | Nectar Foods Inc. | Food | Class II | 1 |
| 18 Nov 2019 | Queen Victoria Sweet Baby Broccoli from Ippolito International, packed in ice in half bushel boxes, 18 count bunches/case, pack date of Nov 07 [2019], twist tie label on each bunch. Packaged by Ippolito International, Salinas, CA 93901 (see photos of labels on pgs. 3-4 of Att A/B in Associated Docs). (84327) | Stern Produce Company Inc. | Food | Class II | 1 |
| 18 Nov 2019 | Hummingbird Wholesale Organic Chia Seeds, SD120-5#, packaged in a clear plastic bag with a while label, net wt. 5 lbs. No UPC code. | Honey Heaven Wholesale Inc | Food | Class II | 1 |
| 15 Nov 2019 | Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 | Arrow International Inc | Device | Class II | 2 |
| 15 Nov 2019 | Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430 | Glenmark Pharmaceuticals Inc., USA | Drug | Class III | 2 |
| 15 Nov 2019 | Breakstones 2% Milkfat Lowfat Large Curd Cottage Cheese, in 16 oz. Plastic Tub, with UPC 0 21000 30053 2, 12 packages per case | THE KRAFT HEINZ COMPANY | Food | Class II | 3 |
| 15 Nov 2019 | CHEESE NIPS (11 oz. BOX), Retail UPC - 0 44000 03453 5, Best When Used By Date - 18MAY20, 19MAY20, 20MAY20 (84307) | Kraft Foods Global Inc | Food | Class II | 1 |
| 14 Nov 2019 | Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 14 Nov 2019 | Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 | Medtronic Perfusion Systems | Device | Class II | 1 |
| 14 Nov 2019 | AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60 | AVKARE Inc. | Drug | Class II | 2 |
| 13 Nov 2019 | Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000 | GETINGE US SALES LLC | Device | Class II | 1 |
| 12 Nov 2019 | Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ | AuroMedics Pharma LLC | Drug | Class II | 1 |
| 12 Nov 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37 | QuVa Pharma, Inc. | Drug | Class II | 27 |
| 12 Nov 2019 | Chef Pineiro's Sofrito con Cilantro, with Coriander, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g) | AC Culinary Group LLC. | Food | Class II | 4 |
| 11 Nov 2019 | smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 11 Nov 2019 | Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05. | AuroMedics Pharma LLC | Drug | Class II | 1 |
| 11 Nov 2019 | Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03 | AuroMedics Pharma LLC | Drug | Class III | 3 |
| 11 Nov 2019 | Marketside Creamy Cauliflower Parmesan Soup 16 ounce UPC Codes: 8113130606 Use By 11/23 through Use by 1/1/20 (84250) | Kettle Cuisine, LLC | Food | Class I | 1 |
| 8 Nov 2019 | CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures. | Cook Inc. | Device | Class I | 4 |
| 8 Nov 2019 | AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet allows for percutaneous removal of thrombus located in… | Boston Scientific Corporation | Device | Class II | 1 |
| 8 Nov 2019 | Great Value Old Fashioned Glazed Donuts packaged in a paperboard box with cellophane window and each box contains 6 donuts. Net Wt. per box: 12 oz. (340 g). UPC on retail box: 0 78742 30711 4. DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. Each master case contains 9/12 oz. boxes of Great Value Old Fashioned… (84286) | United States Bakery Corp | Food | Class III | 1 |
| 7 Nov 2019 | Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the… (84324) | Neuronetrix Solutions, LLC dba Cognision | Device | Class II | 1 |
| 7 Nov 2019 | ARCHITECT HAVAB-G Calibrator, REF 6L27-01 | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 7 Nov 2019 | Ligamax 5 mm Endoscopic Multiple Clip Applier | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 7 Nov 2019 | Freshness Guaranteed Croissants in clear plastic 12oz clamshell, 12 clamshells per case, item number 7012 | Gold Standard Baking, Inc. | Food | Class II | 1 |
| 7 Nov 2019 | Ready to eat Pip Pop Movie Theater Popcorn packaged in 24 oz. laminated plastic zip pouch bag, 6 per case, UPC 004117281119; Made in Orem, Utah. Manufactured for Associated Foods Stores, Salt Lake City, UT 84119. Small sticker label in each bag bears exp date and lot/batch code. (84246) | Water Gardens Confections LLC | Food | Class II | 1 |
| 6 Nov 2019 | Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 2 |
| 6 Nov 2019 | Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round Low 10888628000520, NATRELLE Style 68LP-175 Saline Round Low 10888628000537, NATRELLE Style… | Allergan PLC | Device | Class III | 4 |
| 6 Nov 2019 | DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79 | AuroMedics Pharma LLC | Drug | Class II | 5 |
| 6 Nov 2019 | Amazon Go Vegan Hummus Veggies - Hummus Dip with Veggies, Net weight: 6.2 ounces. UPC: 8 42379 12606 2. | Amazon | Food | Class II | 3 |
| 5 Nov 2019 | Broccoli Cheddar Pasta Salad Kit V 1/3.7625 LBS Distributed By: Russ Davis Wholesale Wadena, MN 56482 UPC 1345435840 Distributed By: Fresh Creative Foods, Vista CA 92801 2/3.7625 LBS UPC 1812906077 | RMJV, LP DBA Fresh Creative Foods | Food | Class I | 2 |
| 5 Nov 2019 | Vitamin D2 Blend packaged in 50 lb. Multi-wall paper bag with polyethylene liner bags | Cain Food Industries, Inc | Food | Class I | 9 |
| 5 Nov 2019 | Nut Bread Net Wt. 16 oz (454 g), Maufactured by Beatrice Bakery Co, Beatrice, NE. (84203) | Beatrice Bakery Co | Food | Class II | 1 |
| 4 Nov 2019 | Healix Knotless ADV BR 4.75 Suture Anchor | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 2 |
| 4 Nov 2019 | Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite¿ 8 System,Catalog No.9770501R Site~Rite 8… | Becton Dickinson & Company | Device | Class II | 1 |
| 4 Nov 2019 | Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis. (84320) | Integra Lifesciences Sales Llc | Device | Class II | 1 |
| 4 Nov 2019 | Klein Foods Cookie Dough Fudge, packed in 1/2 pound boxes (84215) | Klein Foods, Inc | Food | Class II | 1 |
| 4 Nov 2019 | Abundant Foods Good For You Kale Broccoli Salad, Net Weight: 5.0 lbs., Use Within 6 Days of Pack Date, salad kit packaged in plastic, vacuum-sealed pouch, cases vary by weight; packed by Abundant Foods, 6701 E Stapleton Drive North, Denver, CO 80216. Each kit consists of multiple, separate packages of ingredients and… (84247) | Abundant Foods, LLC | Food | Class I | 1 |
| 4 Nov 2019 | Terra Alba Calcium Sulfate Dihydrate packaged in 50 lb. bags; 25 lb. bags; 800kg (1764 lb.) bulk bags; 2000 lb. bulk bags; or approximately 45,000- 48,000 lb. bulk pneumatic tanks (84194) | Harrison Gypsum, LLC | Food | Class I | 1 |
| 4 Nov 2019 | Fresh From Meijer vegetable tray with UPC 2-20185-00000-2 and PLU 1592, packed in clear plastic sectioned container | Meijer Inc. | Food | Class I | 4 |
| 4 Nov 2019 | Sullivan Harbor Farm Smokehouse Refrigerated, Ready-to-Eat, Cold Smoked Salmon in vacuum packaging (4 oz., 8 oz., 1 lb., 2 lb., and whole sides). (84209) | Mill Stream Corp. | Food | Class I | 1 |
| 4 Nov 2019 | Trend Alert Caulilini with Vadouvan Curry served on the salad bar | Whole Foods Market | Food | Class I | 57 |
| 4 Nov 2019 | Kroger Mushroom Stir Fry Blend 10 oz. UPC 82676618482 | Renaissance Food Group, LLC | Food | Class II | 2 |
| 4 Nov 2019 | Fresh Seasons, Fresh Veggie & Ranch Cup, 7.5 ounces, packaged in a plastic 12 ounce cup (84214) | Taher, Inc. | Food | Class I | 1 |
| 3 Nov 2019 | 3021 BROCCOLI FLORETS 3LB; 3026 BROCCOLI DICED 5LB; 3029 BROCCOLI FLORETS 4/3#; 3023 BROCCOLI STIR FRY CUT 4/3# all packaged in plastic flexible bags | Vinyard Fruit & Vegetable Co., Inc. | Food | Class I | 7 |
| 1 Nov 2019 | House Foods Chinese Mabo Tofu Sauce, mild; NET WT. 5.29 oz. (150 g) 4 servings UPC: 0 77377 74064 8 Ingredients: Water, Tomato Paste, Soybean paste (soybean, rice, salt, water), monosodium glutamate, garlic, sugar, sesame oil, ginger, spring onion, salt, cornstarch. mirn (glutinous rice, ice, rice alcohol, enzyme… (84317) | House Foods America Corporation | Food | Class II | 1 |
| 31 Oct 2019 | LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription Compounding, Fagron, Inc., 2400 Pilot… | Fagron, Inc | Drug | Class II | 1 |
| 31 Oct 2019 | Leader Advanced Probiotic with 6 Probiotic Strains and 20 billion Live Cultures. 30 capsules Item Number: CARD40359, Product Number: 907019, UPC Code: 096295136654 | Merical, LLC | Food | Class III | 1 |
| 30 Oct 2019 | Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity. (84249) | Young Dental Manufacturing Co, LLC | Device | Class II | 1 |
| 30 Oct 2019 | Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 | Medtronic Navigation, Inc. | Device | Class II | 3 |
| 30 Oct 2019 | XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment. | Allergan PLC | Device | Class II | 1 |
| 30 Oct 2019 | HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is… | Teleflex Medical | Device | Class II | 1 |
| 30 Oct 2019 | Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A | Medline Industries Inc | Device | Class II | 1 |
| 30 Oct 2019 | Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product number 3248-01, NDC 10106-3248-1; b) 2.5KG glass bottles, product number 3248-05, NDC 10106-3248-2; c) 12KG pails, product number 3248-07, NDC 10106-3248-3; d) 1KT bottles and drums,… (84188) | Avantor Performance Materials Inc | Drug | Class II | 1 |
| 29 Oct 2019 | HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with… | Bio-Signal Group Corp. | Device | Class II | 2 |
| 29 Oct 2019 | Massey Fish Company Smoked salmon pate in 8oz clear plastic tub | Massey Fish Company | Food | Class I | 2 |
| 28 Oct 2019 | Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs. | Smiths Medical ASD Inc. | Device | Class I | 1 |
| 28 Oct 2019 | Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190 | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 25 Oct 2019 | iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one… | Conformis, Inc. | Device | Class II | 1 |
| 25 Oct 2019 | Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660 | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 24 Oct 2019 | Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200, EMERGE MR, OUS 2.00mm X 12mm; 4. REF/Catalog No.… | Boston Scientific Corporation | Device | Class II | 4 |
| 24 Oct 2019 | North Bay Produce brand McIntosh, Honeycrisp, Jonathan, Fuji, Jonamac and Red Delicious apples sold in 2 lbs and 3 lbs plastic bags, white paper quarter peck bags, half peck clear plastic tote bags, 600lb bulk, and individually from retailers display trays. (84141) | NORTH BAY PRODUCE INC. | Food | Class I | 1 |
| 23 Oct 2019 | Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada | Abbott GmBH & Co. KG | Device | Class II | 1 |
| 23 Oct 2019 | Boulder Chocolate Maple Pear Brandy Flambe Truffles, 2.6 oz, packed in plastic box, 4/pkg., 6 pkgs/case (84153) | Lift Chocolate, LLC | Food | Class II | 1 |
| 22 Oct 2019 | Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam | Steris Corporation | Device | Class II | 1 |
| 22 Oct 2019 | Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: Gravity designed for sterilization of non-porous, heat- and moisture stabile goods, and sterilization… | Steris Corporation | Device | Class II | 1 |
| 22 Oct 2019 | Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87. | Sanofi-Aventis U.S. LLC | Drug | Class II | 12 |
| 21 Oct 2019 | C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System | Integra LifeSciences Corp. | Device | Class II | 42 |
| 21 Oct 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610 | Boston Scientific Corporation | Device | Class II | 13 |
| 21 Oct 2019 | Vegetable eggroll 2 oz. and 3 oz. | T & R Enterprises USA, Inc. | Food | Class II | 2 |
| 18 Oct 2019 | Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970 | CP Medical Inc | Device | Class II | 1 |
| 18 Oct 2019 | BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries. | Brasseler USA I Lp | Device | Class II | 1 |
| 16 Oct 2019 | Quantam 2000 Electrosurgical Generator, Part number 909075. | CooperSurgical, Inc. | Device | Class II | 3 |
| 14 Oct 2019 | Radiofrequency Grounding Pad, REF RF-DGP-L | Abbott Medical | Device | Class II | 1 |
| 14 Oct 2019 | Natural Grocers SOYBEANS ORGANIC in 2.0 lbs (32 oz) (907 g) plastic retail bags, 9 bags/case, Packaged by Vitamin Cottage (84275) | Vitamin Cottage Natural Foods Market, Inc DBA Natural Grocers | Food | Class III | 1 |
| 11 Oct 2019 | Giraffe OmniBed infant warmer | GE Healthcare, LLC | Device | Class I | 4 |
| 11 Oct 2019 | Synchromed II programmable pump, Model numbers 8637-20 and 8637-40 (84037) | Individual firm, name withheld | Device | Class I | 1 |
| 11 Oct 2019 | Pasteurized Process American Cheese, white, 6 - 5lb loaves per case. Brands as follows: 1) Foodtown; 2) Hannaford; 3) Wegmans | Great Lakes Cheese Co Inc | Food | Class III | 6 |
| 9 Oct 2019 | Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in… | Nextremity Solutions | Device | Class II | 1 |
| 8 Oct 2019 | Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in… | Teleflex Medical | Device | Class II | 3 |
| 7 Oct 2019 | UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and… | Beckman Coulter, Inc. | Device | Class II | 1 |
| 4 Oct 2019 | Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 3 Oct 2019 | HeartStart XL+ Defibrillator/Monitor, Model 861290 | Philips North America, LLC | Device | Class II | 1 |
| 3 Oct 2019 | Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025 | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 1 Oct 2019 | Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy | New Vitalis Pharmacy LLC dba New Vitalis Pharmacy | Drug | Class II | 1 |
| 27 Sep 2019 | GOYA FRUTA Tamarillo WHOLE - Tomate de Arbol Net weight / number of units per package: 14 ounces / About 6 pieces of fruit per bag, Package type: Plastic bag / Units per case if applicable: 8 (83929) | GOYA FOODS INC. | Food | Class II | 1 |
| 26 Sep 2019 | TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain. | Theralase Inc. | Device | Class III | 2 |
| 25 Sep 2019 | myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure. (83882) | ENDOTRONIX | Device | Class II | 1 |
| 24 Sep 2019 | 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. | Device | Class II | 1 |
| 23 Sep 2019 | Atellica CH 930 Analyzer | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 18 Sep 2019 | Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ,… | GN Hearing A/S | Device | Class II | 2 |
| 18 Sep 2019 | EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case. | Medline Industries Inc | Device | Class II | 1 |
| 17 Sep 2019 | Siracha HOT Chili Sauce Net Wt. 28 oz. (1 lb. 12 oz.) (793 g); Net Wt. 17 oz. (1 Lb. 1 oz.) in PET Plastic bottles UPC: 0 24463 06116 Huy Fong Foods, Inc. 4800 Azusa Rd. Irwindale, CA 91706 (84491) | Huy Fong Foods, Inc | Food | Class III | 1 |
| 16 Sep 2019 | Alinity ci Level Sensor, Bulk Solution | Abbott Gmbh & Co. KG | Device | Class II | 3 |
| 12 Sep 2019 | Fortune Fish & Gourmet fresh Atlantic salmon, whole, filleted, and filleted without belly sold by weight in cardboard box with ice (84198) | Fortune International, LLC DBA Fortune Fish & Gourmet LLC | Food | Class II | 1 |
| 4 Sep 2019 | 365 Everyday Value Organic Instant Oatmeal Maple and Brown Sugar Pecan With Other Natural Flavors UPC 9948247977 NET WT 2.3 OZ. microwaveable cups cold individually | Whole Foods Market | Food | Class III | 1 |
| 3 Sep 2019 | Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Coast Quality Pharmacy, LLC dba Anazao Health | Drug | Class II | 31 |
| 3 Sep 2019 | TAINY VOSTOKA DRY FRUIT MIX QUINCE COMPOTE 17.65oz (500 gram); Container code# 27032019; UPC code 4605932006203. (84333) | Euroline Foods LLC | Food | Class I | 1 |
| 27 Aug 2019 | Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A; | NxStage Medical, Inc. | Device | Class II | 1 |
| 21 Aug 2019 | Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733… | Zimmer Biomet, Inc. | Device | Class II | 15 |
| 8 Aug 2019 | FoundationOne CDx test report | Foundation Medicine, Inc. | Device | Class II | 1 |
| 6 Aug 2019 | ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 1 Aug 2019 | Rocket KCH Fetal Bladder Drainage Catheter Model: R57405 (83587) | Rocket Medical Plc | Device | Class II | 1 |
| 19 Jul 2019 | Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n)… | GE Healthcare, LLC | Device | Class II | 4 |
| 30 May 2019 | Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409, | Surgery Pharmacy Services Inc | Drug | Class II | 2 |
| 3 Mar 2019 | MRIdian Linac Radiation Therapy System Model 10000 and 20000 | Viewray, Inc. | Device | Class II | 1 |
| 19 Feb 2019 | Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to… | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 18 Feb 2019 | LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code Stent Diameter Stent length Catheter Length… | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 15 Feb 2019 | QuickTox 5 Panel Drug Screen DipCard | Ameditech Inc | Device | Class III | 1 |
| 14 Feb 2019 | PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 5 Feb 2019 | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures | SPINEART SA | Device | Class III | 1 |
| 4 Feb 2019 | EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096 | Encore Medical, Lp | Device | Class II | 1 |
| 31 Jan 2019 | Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand. (84126) | RHONDIUM LIMITED | Device | Class II | 1 |
| 18 Jan 2019 | SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe and calm skin (cosmetic). The SKINFUSE LIFT HG is a hydrogel wound dressing to protect against abrasion and friction during the microneedling procedure. (84154) | Bellus Medical | Device | Class II | 1 |
| 15 Jan 2019 | Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can be simply lagged… (84230) | Miami Device Solutions, LLC. | Device | Class II | 1 |
| 7 Dec 2018 | Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA. | Spectranetics Corporation | Device | Class II | 1 |
| 6 Dec 2018 | Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN… | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 6 Dec 2018 | VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation… | Carl Zeiss Meditec, Inc. | Device | Class II | 1 |
| 16 Nov 2018 | VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly | LivaNova USA Inc | Device | Class II | 1 |
| 15 Nov 2018 | V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180 (83910) | Individual firm, name withheld | Device | Class II | 1 |
| 9 Nov 2018 | TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA. (83903) | Tekia, Inc. | Device | Class II | 1 |
| 7 Nov 2018 | Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 807401200; (3) s5i Imaging System,… | Volcano Corporation | Device | Class II | 1 |
| 28 Sep 2018 | P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only | Paragon 28, Inc. | Device | Class II | 1 |
| 14 Aug 2018 | Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX. (83595) | Individual firm, name withheld | Device | Class II | 1 |
| 23 May 2018 | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C,… | Helena Laboratories, Corp. | Device | Class III | 2 |
| 15 Aug 2017 | EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1 | NDDd Medical Technologies, Inc. | Device | Class II | 2 |
| 2 Dec 2016 | A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058 | Polymer Technology Systems | Device | Class II | 5 |
| 8 Nov 2016 | SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104 | Wright Medical Technology, Inc. | Device | Class II | 12 |
| 6 Oct 2014 | Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no.… (83830) | Alliance Tech Medical, Inc | Device | Class II | 1 |
| 5 Jun 2013 | PANTERA Proximal Humerus Fracture Plate System (83963) | Toby Orthopaedics, Inc. | Device | Class II | 1 |