| 14 Jan 2020 | methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01. | Hikma Pharmaceuticals USA Inc. | Drug | Class III | 1 |
| 14 Jan 2020 | Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 2 |
| 10 Jan 2020 | NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40. | Advanced Accelerator Applications USA, Inc. | Drug | Class II | 1 |
| 10 Jan 2020 | Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13… | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 10 Jan 2020 | Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) 500 gm NDC 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601 (84686) | Letco Medical LLC | Drug | Class II | 1 |
| 10 Jan 2020 | 13 Bean Soup Mix is sold under Bob's Red Mill brand, packaged in Form & Fill (29 oz. and 822 gram), Standup Pouch (29 oz.), and Bulk Bags (25 lbs.) Product has the following UPC: UPC: 039978122513 UPC: 039978002518 UPC: 039978102515 (25 lb. bag) UPC: 039978302519 (distributed in Canada) | Bob's Red Mill Natural Foods, Inc. | Food | Class III | 2 |
| 9 Jan 2020 | Signature Crab Cake, Signature Crab Cake (2 pk), and Signature Crab Cake (4pk); Wegmans Ready to Cook Signature Crab Cake; Oven ready tray; various sizes, keep Refrigerated or Frozen | Wegmans Food Markets, Inc. | Food | Class II | 22 |
| 7 Jan 2020 | Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | Palodex Group Oy | Device | Class II | 4 |
| 7 Jan 2020 | Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30. | Appco Pharma LLC | Drug | Class II | 2 |
| 7 Jan 2020 | Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. (84678) | Sigan Industries Inc. | Drug | Class III | 1 |
| 7 Jan 2020 | Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1) | Preferred Pharmaceuticals, Inc | Drug | Class II | 2 |
| 7 Jan 2020 | Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13. | AVKARE Inc. | Drug | Class II | 1 |
| 7 Jan 2020 | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91. | Mylan Pharmaceuticals Inc. | Drug | Class II | 2 |
| 6 Jan 2020 | Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and controls for the collimator… | Carestream Health, Inc. | Device | Class II | 1 |
| 6 Jan 2020 | Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60 | H J Harkins Company Inc dba Pharma Pac | Drug | Class II | 1 |
| 6 Jan 2020 | Dry Garbanzo Beans are sold under different brands and described as follows: -Bulk 2000 lbs. Totes. -CBP brand 25# Paper Bags 035084321925. -FIESTA brand 25# Paper Bags 035084225070. -Home Pride brand 50# Paper Bags 035084225070. -WinCo 24/1 lbs Small Pack 070552704305. | Columbia Bean & Produce, Inc. | Food | Class III | 2 |
| 2 Jan 2020 | purely elizabeth Chocolate Sea Salt probiotic granola. Net Wt. 8 oz (227g). UPC 55140-00268. Made with organic quinoa, amaranth and chia. Contains Coconut. May contain Walnuts, Cashews and Almonds. Made in a facility that also processes soy, milk, eggs, peanuts and other tree nuts. (84613) | Individual firm, name withheld | Food | Class II | 1 |
| 31 Dec 2019 | Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images. (84615) | Koios Medical, Inc. | Device | Class II | 1 |
| 31 Dec 2019 | Dark with Browned Ghee is wrapped in a foil and jacketed with black paper. There is a white sticker on the front that says Sanity Chocolate. On the back label there is the batch name listed above, address listed above and ingredient list. Average net weight is 0.75 oz. There is no UPC code. The label is read in… (84644) | Individual firm, name withheld | Food | Class II | 1 |
| 30 Dec 2019 | Morrison's cornbread dressing packaged in 4lb tray | Savannah Food Company, Inc. | Food | Class II | 6 |
| 27 Dec 2019 | Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC | Cook Inc. | Device | Class II | 1 |
| 27 Dec 2019 | Simply Fresh brand MiniMeals2Go Protein Pack (8.25 OZ) ready-to-eat snack packs | Five Star Gourmet Foods of Florida | Food | Class I | 2 |
| 27 Dec 2019 | RTE bacon and eggs 3.6 oz package (84641) | Individual firm, name withheld | Food | Class I | 1 |
| 27 Dec 2019 | Garden Salad Kit: 7lbs packaged in cardboard box | Fresh Unlimited Inc | Food | Class I | 3 |
| 26 Dec 2019 | Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01. | AAA Pharmaceutical, Inc. | Drug | Class II | 2 |
| 26 Dec 2019 | Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 26 Dec 2019 | Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count bottles, (NDC 62756-521-88), Rx only, Sun Pharma, Cranbury, NJ | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 2 |
| 26 Dec 2019 | SimplySafe Sesame Seed Hulled; 49lbs bag; Lot #PBAT10025110 (84580) | Bay State Milling Co. | Food | Class II | 1 |
| 26 Dec 2019 | Cece's Veggie Co. brand Fresh Veggie Ramen with Chicken Broth (11.5 oz, UPC 5228700653) packaged in a plastic tray (84589) | Veggie Noodle Co | Food | Class I | 1 |
| 24 Dec 2019 | Dierbergs Kitchen Kosher-Style Potato Salad, packaged in 12 OZ containers UPC 23753400000 and in bulk by pound containers UPC 23494500000 | Dierbergs Markets, Inc Corporate Office | Food | Class I | 6 |
| 23 Dec 2019 | Pro2Snax To The Max snack tray containing Sliced Apples, Hard Boiled Egg, Mild Cheddar Cheese, and Dried Cranberries & Cashews. Item # 1-4555-6. Net Wt. 7.35 oz (208g) UPC 6 49632-00149 0 Keep Refrigerated. | Reichel Foods Inc. | Food | Class I | 2 |
| 23 Dec 2019 | Royal Farms Barbecue Dipping Sauce, Net Wt. 1.5 OZ Distributed by Royal Farms, Baltimore MD packaged in plastic cups, 228 cups to a case. (84576) | Sauer Brands, Inc. - New Century | Food | Class II | 1 |
| 20 Dec 2019 | LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad. | Physio-Control, Inc. | Device | Class II | 2 |
| 20 Dec 2019 | Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 20 Dec 2019 | PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397. | Island Kinetics, Inc. d.b.a. CoValence Laboratories | Drug | Class III | 1 |
| 20 Dec 2019 | Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800 | Assurance Infusion | Drug | Class II | 118 |
| 20 Dec 2019 | Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131. | Denton Pharma, Inc. | Drug | Class II | 2 |
| 20 Dec 2019 | MADAME SARAH brand DJON DJON dried mushrooms; NET WEIGHT 1.76oz (50g); PRODUCT OF HAITI; INGREDIENTS: DRIED DJON DJON MUSHROOMS; DISTRIBUTED BY: HORIZON VERT PURE, LLC (84563) | Horizon Vert Pure Llc | Food | Class III | 1 |
| 20 Dec 2019 | Emesa Foods Premium Sesame Tahini, in 28.2oz plastic jars, UPC 850005298267, 6 jars per case (84540) | EMESA FOODS CO | Food | Class I | 1 |
| 19 Dec 2019 | Organic Cold brew BUDDY BREW COFFEE BOLT Original 10.5 oz. cans and 5 and 7.5 gallon kegs | Individual firm, name withheld | Food | Class II | 2 |
| 18 Dec 2019 | Smoked Salmon Chowder, Pike Place Chowder brand, item #89201, distributed By PPC Trading Co. M. BOX #262 4580 Klahanie Drive SE Issaquah WA 98029. There are 16/16 oz. retail packages per master case. Retail package net wt. 16 oz. UPC 8 56112 00406 7. The 16 oz. inner individual pouch has a clear film lid and the… | Northwest Gourmet Food Products Inc | Food | Class II | 2 |
| 17 Dec 2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60 | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 6 |
| 17 Dec 2019 | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA. | Hikma Pharmaceuticals USA Inc. | Drug | Class I | 2 |
| 17 Dec 2019 | Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX | Motto International Corp | Drug | Class I | 4 |
| 17 Dec 2019 | GREY GHOST BAKERY scratch-made cookies LEMON SUGAR NET WT 1.4 OZ (40 G), UPC 8 53152 00308 1 , 4 OZ (113 G) UPC 8 53152 00332 6 & 8 OZ (225 G) UPC 8 53152 00307 4 GREY GHOST BAKERY 1750 SIGNAL POINT RD, STE 2A CHARLESTON, SC 29412 (84523) | TFI Holding dba Grey Ghost Bakery | Food | Class II | 1 |
| 16 Dec 2019 | Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources. | GE Healthcare, LLC | Device | Class II | 1 |
| 16 Dec 2019 | Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. | Microbiologics Inc | Device | Class II | 1 |
| 16 Dec 2019 | NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478. | Pharmedium Services, LLC | Drug | Class III | 3 |
| 16 Dec 2019 | Stop and Shop brand Grilled Salmon meal with cooked brown rice, quinoa blend, broccoli florets, cooked white rice, fire roasted edamame, garlic and herb butter, bell pepper, roasted corn and carrots, Net Wt. 12.8 OZ (363g) | Taylor Farms New England, Inc. | Food | Class II | 2 |
| 14 Dec 2019 | HOME CHEF HEAT & EAT Baked Macaroni & Cheese NET WT. 12 oz (340G) keep refrigerated, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, UPC 8 12071 03555 9 | Bakkavor Foods USA Inc. | Food | Class II | 1 |
| 13 Dec 2019 | ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for… | CooperSurgical, Inc. | Device | Class II | 1 |
| 13 Dec 2019 | RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32 (84522) | Granules India Limited | Drug | Class II | 1 |
| 13 Dec 2019 | Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03. | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 13 Dec 2019 | Plant Based WayFare Chocolate Pudding Organic Dairy Free, Item #1222. Net wt. 4 oz. There are 4/4 oz. cups per pack with cardboard overwrap. UPC 845681000365. | Wayfare Health Foods LLC | Food | Class II | 3 |
| 12 Dec 2019 | Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through a vascular access device. | Baxter Healthcare Corporation | Device | Class II | 2 |
| 12 Dec 2019 | Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels. | Arrow International Inc | Device | Class II | 1 |
| 11 Dec 2019 | Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10). | Suntech Medical, Inc. | Device | Class II | 1 |
| 11 Dec 2019 | Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248. | Spectrum Laboratory Products | Drug | Class II | 1 |
| 11 Dec 2019 | Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00 | RemedyRepack Inc. | Drug | Class II | 1 |
| 10 Dec 2019 | Classic Lays potato chips 2 3/4 oz. UPC 28400 42054; Classic Lays potato chips 8 oz. UPC 28400 19914; Classic Lays potato chips 10 oz. UPC 28400 64549; Classic Lays potato chips 15 1/4 oz. UPC 28400 64474; Classic Lays potato chips 15 7/8 oz. UPC 28400 11087 all packaged in flexible plastic bags | Frito-Lay, Inc. | Food | Class III | 1 |
| 9 Dec 2019 | Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 | Abbott Medical | Device | Class II | 1 |
| 9 Dec 2019 | Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential. | Abbott Medical | Device | Class II | 1 |
| 9 Dec 2019 | Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36 | Asclemed USA Inc. dba Enovachem Pharmaceuticals | Drug | Class II | 3 |
| 9 Dec 2019 | Quesillo Salvadoreno Para Pupusa Salvadorean String Cheese; 1 lb. (84501) | Limena, LLC | Food | Class II | 1 |
| 6 Dec 2019 | Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH | Arrow International Inc | Device | Class II | 1 |
| 6 Dec 2019 | Butler's Dark Chocolate with Irish Whisky, 3.52oz bar, UPC 8 44984 17619 7, 10 units per case (84455) | Gourmet International Ltd. | Food | Class I | 1 |
| 6 Dec 2019 | Frozen Yellowfin Tuna Loins, 5-8 lbs, Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328 | Northern Fisheries Ltd. | Food | Class II | 3 |
| 6 Dec 2019 | R.H. Macys & Co. Roasted Salted Cherries Berries and Nuts with Dark Chocolate, in 10oz metal tin, UPC - 788709600362 | Ferris Coffee and Nut Company, Inc. | Food | Class II | 2 |
| 5 Dec 2019 | Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050 | Stryker GmbH | Device | Class II | 1 |
| 4 Dec 2019 | Chicken of the Sea Sardines in Water; Net Wt. 3.75 oz. (106g) UPC 0 48000 00707 0 18 Individual items per case Ingredient: Sardines, water, salt. Distributed by Chicken of the Sea International, San Diego, CA Product of Poland. (84444) | CHICKEN OF THE SEA | Food | Class III | 1 |
| 4 Dec 2019 | NANCY ADAMS DARK CHOCOLATE Graham Crackers, NET WT 7.5 OZ (212G); UPC 618645275860; packaged in a brown paper bag with a clear window (84426) | Nassau Candy Distributors, Inc. | Food | Class II | 1 |
| 4 Dec 2019 | White Castle Sliders - Cheese Sliders - Cheeseburgers UPC 8298801006 (6pk Cheeseburger), UPC 829880116 (16pk Cheeseburger) | Individual firm, name withheld | Food | Class II | 3 |
| 3 Dec 2019 | Mrs. Condies Salad Company's Honey Bear Small Party Platter containing Ranch Dressing dip,3.5 lbs. (84457) | Individual firm, name withheld | Food | Class I | 1 |
| 3 Dec 2019 | Hannaford brand Macaroni and Cheese, NET WEIGHT 12 OZ (340g); KEEP REFRIGERATED; UPC: 0 4126821062 6; Heating Instructions: Microwave: Remove lid. Heat for 3 minutes or until temperature reaches 165 degrees F. Let stand for 2 minutes and serve. (84409) | R. Walters Limited dba Meninno Brothers Foods | Food | Class II | 1 |
| 3 Dec 2019 | Suantianyangmei Waxberry, 8.11 OZ (230g) clear plastic containers, UPC 6948576407226 and 3.12.2020 stamped on the box | Lin's Waha International Corp. | Food | Class I | 2 |
| 2 Dec 2019 | Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B ***PEDS CVC*** Clear Sequence Change Kit, REF 77190B ***PICC*** Clear Sequence Change Kit, REF 77069B Adult Central Line Dressing Change… | Medical Action Industries, Inc. 306 | Device | Class II | 1 |
| 2 Dec 2019 | Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage. | Degania Silicone, Ltd. | Device | Class II | 1 |
| 2 Dec 2019 | HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: Provides power to the System Controller… | Thoratec Corp. | Device | Class II | 1 |
| 2 Dec 2019 | Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size). | Medela Inc | Device | Class II | 1 |
| 2 Dec 2019 | PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700 | Polymer Technology Systems, Inc. | Device | Class II | 4 |
| 2 Dec 2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03. | AuroMedics Pharma LLC | Drug | Class III | 1 |
| 2 Dec 2019 | Belle Mar Stuffing 5 lb. (2.27 kg) Bulk Plastic Container,6 - 5 lb. containers per case , Keep Frozen | ASK Foods Inc | Food | Class II | 2 |
| 29 Nov 2019 | Shredded Cheddar Cheese Packaged in plastic 5lb bags, 4 bags per box | Middlefield Original Cheese Coop | Food | Class I | 4 |
| 27 Nov 2019 | QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705 | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 27 Nov 2019 | BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or… | Flexicare Medical Ltd. | Device | Class II | 4 |
| 26 Nov 2019 | iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRIS Neuro 3T System. The System is a… | Deerfield Imaging, Inc. | Device | Class II | 1 |
| 26 Nov 2019 | Great Value Macadamia Nuts 4 oz. pouch with UPC CODE: 078742309422 packaged in a cello bag, 6 per case | Texas Star Nut and Food Co., Inc. | Food | Class II | 1 |
| 26 Nov 2019 | Wild Harvest Organic Unbleached All Purpose Flour, Net Wt 5 lb. (2.26 kg) in paper bags, UPC 7 11535 50915 8, 8 bags per case. | Ardent Mills LLC | Food | Class II | 1 |
| 26 Nov 2019 | Trader Joe's 8pcs Spicy California Roll, 8oz, SKU 00348966T | Fuji Food Products, Inc. | Food | Class I | 23 |
| 26 Nov 2019 | Sea Mart Frozen Yellowfin Tuna Steak, CO treated, skinless, boneless, bloodline removed, 8 oz, 10lb package | AQUABEST SEAFOOD LLC | Food | Class II | 3 |
| 25 Nov 2019 | Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 25 Nov 2019 | Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult. | GE Healthcare, LLC | Device | Class I | 2 |
| 25 Nov 2019 | VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory. | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 21 Nov 2019 | The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced for DeWALT and Stanley by a contract manufacturer. (84499) | STANLEY BLACK & DECKER INC. | Device | Class II | 1 |
| 21 Nov 2019 | Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity… | Stryker GmbH | Device | Class II | 1 |
| 21 Nov 2019 | CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities. | Caire, Inc. | Device | Class II | 1 |
| 21 Nov 2019 | 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136 | 3M Company - Health Care Business | Device | Class II | 1 |
| 21 Nov 2019 | Tobago Keys brand Coral Ridge Seafood Dipping Sauce 12 FL.OZ. (355 ml) and Peruvian Gold Grilling Sauce 12 FL.OZ (355 ml) (84606) | Endorphin Farms, Inc. | Food | Class II | 1 |
| 20 Nov 2019 | SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912 | Idelle Labs | Drug | Class III | 4 |
| 18 Nov 2019 | STA UNICALIBRATOR (ref. 00675) | Diagnostica Stago, Inc. | Device | Class II | 2 |
| 18 Nov 2019 | Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020 | Paltop Advanced Dental Solutions Ltd | Device | Class II | 1 |
| 18 Nov 2019 | RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 18 Nov 2019 | There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption… (84371) | Nucletron BV | Device | Class II | 1 |
| 15 Nov 2019 | O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 | Medtronic Navigation, Inc.-Littleton | Device | Class II | 1 |
| 15 Nov 2019 | AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706 | Tosoh Smd Inc | Device | Class III | 1 |
| 15 Nov 2019 | MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13. | Akorn, Inc. | Drug | Class II | 1 |
| 15 Nov 2019 | Chef Pierre 37 Ounce Pumpkin Spice Latte Pie, in foil pie pan with dome lid, frozen, 4 pies per wholesale case, with SKU number 09368 and UPC number 032100093682 (84292) | SARA LEE FROZEN FOODS | Food | Class III | 1 |
| 14 Nov 2019 | S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine… | Cardinal Health Inc. | Device | Class II | 3 |
| 14 Nov 2019 | Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) 28-count carton (NDC 68093-0730-2 and 68093-0730-4), Manufactured for: Vitanica, 12401 SW Leveton Drive, Tualatin, OR 97062. (84291) | Wisconsin Pharmacal Company, LLC | Drug | Class II | 1 |
| 13 Nov 2019 | Lamicel 20PK 3MM INTL Cervical dilator | Medtronic Xomed, Inc. | Device | Class II | 3 |
| 13 Nov 2019 | Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698. (84279) | Individual firm, name withheld | Drug | Class I | 1 |
| 12 Nov 2019 | ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this… | GE Healthcare, LLC | Device | Class II | 3 |
| 11 Nov 2019 | Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST | Nextremity Solutions | Device | Class II | 3 |
| 11 Nov 2019 | CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip… | Abbott Medical | Device | Class II | 1 |
| 7 Nov 2019 | iChem VELOCITY Urine Chemistry Analyzer | Beckman Coulter Inc. | Device | Class II | 1 |
| 7 Nov 2019 | Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254 | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 5 Nov 2019 | Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; 3. REF 202, Elbow, SAP Finished Product Code 109382903; 4. REF 195-5 Y-Adapter, SAP Finished Product Code 109838302. | Avanos Medical, Inc. | Device | Class II | 1 |
| 4 Nov 2019 | Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff… | Medacta Usa Inc | Device | Class II | 1 |
| 4 Nov 2019 | Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures. | Villa Sistemi Medicali S.P.A. | Device | Class II | 4 |
| 1 Nov 2019 | Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69) | American Health Packaging | Drug | Class II | 1 |
| 30 Oct 2019 | Simply Delicious Nestle Toll House Chocolate Chip Cookie Dough (18oz), UPC 050000688760 | Gerber Products Company dba Nestle Infant Nutrition | Food | Class II | 26 |
| 25 Oct 2019 | BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 16 Oct 2019 | i-STAT cTnI cartridge | Abbott Point Of Care Inc. | Device | Class II | 1 |
| 14 Oct 2019 | 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems. | Ortho Clinical Diagnostics Inc | Device | Class II | 2 |
| 11 Oct 2019 | ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The ElectroTek is intended to be used for such… | LIFELINES NEURO COMPANY | Device | Class II | 2 |
| 30 Sep 2019 | Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness… | Roche Diabetes Care, Inc. | Device | Class II | 6 |
| 27 Sep 2019 | CARESCAPE Respiratory Module E-sCO | GE Healthcare, LLC | Device | Class I | 7 |
| 19 Sep 2019 | Tidal Seafood Yellowfin Tuna Round Steaks; Frozen Thunnus Albacares; Net Wt.: 20 lbs. 6-8 oz. individually vacuumed packed steaks distributed Globally by: Global Protein Group, Irvine, CA (84507) | Sym-Pac International Inc | Food | Class II | 1 |
| 16 Sep 2019 | Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130 | Medicrea International | Device | Class II | 2 |
| 16 Sep 2019 | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only. | Axis-Shield Diagnostics, Ltd. | Device | Class II | 3 |
| 24 Aug 2019 | Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302 (83757) | Tuscano and Delucia Group (DBA Entropic Labs) | Drug | Class II | 1 |
| 22 Aug 2019 | VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy | LivaNova USA Inc | Device | Class I | 1 |
| 7 Aug 2019 | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector. | Intersurgical Inc | Device | Class II | 4 |
| 1 Aug 2019 | LightPod ERA lasers | Aerolase Corporation | Device | Class II | 2 |
| 1 Aug 2019 | Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only, | Imactis | Device | Class II | 1 |
| 22 Jul 2019 | Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308 | Siemens Healthcare Diagnostics, Inc | Device | Class II | 3 |
| 2 Jul 2019 | Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868 | Mazor Robotics Ltd | Device | Class II | 1 |
| 27 Jun 2019 | Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM, PARAFUSO PEDICULAR POLIAXIAL 7.5MM x 45MM,… | Medicrea International | Device | Class II | 1 |
| 30 May 2019 | Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562 | Galemed Corporation | Device | Class I | 3 |
| 19 Apr 2019 | Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3 | Isopure Corp | Device | Class II | 3 |
| 14 Mar 2019 | Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal. | Trilliant Surgical, LLC | Device | Class II | 1 |
| 6 Mar 2019 | TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877 | Acclarent, Inc. | Device | Class II | 3 |
| 27 Feb 2019 | Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500 | Teleflex Medical | Device | Class III | 2 |
| 25 Feb 2019 | NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. | Nidek, Inc. | Device | Class III | 1 |
| 8 Feb 2019 | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR. | Riverpoint Medical, LLC | Device | Class II | 1 |
| 25 Jan 2019 | INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453 | AAP Implantate Ag | Device | Class III | 2 |
| 10 Jan 2019 | Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704 | McGuff Compounding Pharmacy Services, Inc. | Drug | Class II | 1 |
| 18 Dec 2018 | Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.) | Cochlear Americas Inc. | Device | Class II | 1 |
| 28 Nov 2018 | ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 2 |
| 16 Oct 2018 | The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular… | Carl Zeiss Meditec, Inc. | Device | Class II | 1 |
| 13 Apr 2018 | Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect… | St Jude Medical, Cardiac Rhythm Management Division | Device | Class II | 1 |
| 15 Mar 2016 | PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers | Polymer Technology Systems, Inc. | Device | Class II | 1 |