| 15 Jan 2021 | FITNESS LABS***Organic***Coconut Oil***Extra Virgin***16 fl. oz. (473 mL)***Carefully Designed and Distributed by Piping Rock Health Products, LLC Ronkonkoma, NY 11779*** (87177) | Piping Rock Health Products | Food | Class II | 1 |
| 11 Jan 2021 | Frozen Tuna Ground Meat - Khee Trading Brand Product of Vietnam 22 Lb. Cartons (2 x 11 lb.) | Khee Trading, Inc. | Food | Class II | 1 |
| 8 Jan 2021 | JTM FOOD GROUP brand READY TO EAT WHITE CHEDDAR MACARONI & CHEESE in 5 lb. plastic bags, 6 bags per case. (87159) | JTM Provisions Co Inc | Food | Class II | 1 |
| 7 Jan 2021 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11 | American Health Packaging | Drug | Class II | 1 |
| 7 Jan 2021 | SAMYANG Buldak Hot Chicken Flavor Sauce, Hot Chili Sauce, Net Wt.: 200g (7.05oz) | BLUE STONE IMPORT USA INC | Food | Class II | 3 |
| 7 Jan 2021 | First Street Goody Goody Trail Mix 10 oz. (283g)S&F Item#52892 Unit UPC# 797565204201; First Street Goody Goody Trail Mix 16 oz. (454g) S&F Item#52651 Unit UPC# 797565204225; Western Mixers Goody Goody Trail Mix 10 oz. (283g) Unit UPC# 797565210363 Packed in clear plastic clamshells. Product of USA | Western Mixers Produce & Nuts, Inc. | Food | Class II | 1 |
| 4 Jan 2021 | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01 | Nostrum Laboratories Inc | Drug | Class II | 1 |
| 1 Jan 2021 | Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080. | Precision Dose Inc. | Drug | Class II | 1 |
| 31 Dec 2020 | AF01886 NTFA No egg Ready-to-Eat Chocolate Chip Cookie Dough Dough- 20 lb. sold frozen (87070) | Rhino Foods, Inc. | Food | Class I | 1 |
| 30 Dec 2020 | ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only. | Beckman Coulter Inc. | Device | Class II | 1 |
| 30 Dec 2020 | Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10. | Allergan, PLC. | Drug | Class II | 1 |
| 30 Dec 2020 | Frozen Ground Tuna, Wild Caught, Production Date: 06/01/2020. Product of Vietnam, Net Wt: 11 lbs. x 2: 22 lbs. Imported by Khee Trading, Inc., Compton, CA 90221 The ground tuna comes in a 22 lb. master carton that has two 11 lb. inner cartons. Inner cartons have 11 packs of 1 lb. vacuum packed ground tuna. (87065) | Ocean Providence Minneapolis LLC | Food | Class II | 1 |
| 29 Dec 2020 | "Divvies Vegan and Nut Free Vanilla Cupcakes with Chocolate Frosting ***Net. Wt. 6 oz.***" | Divvies LLC | Food | Class I | 2 |
| 29 Dec 2020 | Valanga Gourmet brand Snickerdoodle Cookie with cinnamon sugar on the outside. Each cookie is wrapped and sold individually. Expected shelf life 6 months frozen and 2 months refrigerated. Net wt. 4.4 oz (124g). UPC 814524616004. The Snickerdoodle Cookie label is read in parts: "***Ingredients: Flour (Wheat Flour,… (87066) | Avalanche Distributing, LLC | Food | Class II | 1 |
| 28 Dec 2020 | Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16 | Akorn, Inc. | Drug | Class II | 1 |
| 28 Dec 2020 | Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL | Sunstar Americas, Inc. | Drug | Class II | 1 |
| 24 Dec 2020 | Backroad Country Spicy Cajun Mix 9 oz (255g) plastic bag. Packed by Troyer Manufacturing Millersburg, OH 44654. | Lipari Foods Operating Company, LLC. | Food | Class I | 1 |
| 23 Dec 2020 | A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone. | Biomet, Inc. | Device | Class II | 1 |
| 23 Dec 2020 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups) (87044) | Genus Lifesciences Inc. | Drug | Class III | 1 |
| 23 Dec 2020 | Herring in Oil with Italian Spices: Ingredients: Herring fillet pieces (fish) sunflower oil refined deodorized, edible salt, ground spices (chili, mustard, coriander, acidity regulators: acetic acid, glucono-delta-lactone; antioxidants; dihdroxysuccinic acid, citric acid, d-glucose, glucose syrup solution,,… (87046) | B & I Overseas Trading Inc. | Food | Class I | 1 |
| 22 Dec 2020 | Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25 | Abbott Point Of Care Inc. | Device | Class II | 2 |
| 22 Dec 2020 | NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 | Strides Pharma Inc. | Drug | Class III | 1 |
| 22 Dec 2020 | Food Club Garlic Powder, 5.37 ounce bottles, 12 bottles per case. " Best 324A0 C By NOV 19 22 / Best 325A0 By NOV 20 22 | B&G Foods North America, Inc | Food | Class I | 1 |
| 22 Dec 2020 | Asian Noodle Salad Kit 2/5 lb. Keep refrigerated Amazon UPC: 826767000000; Whole Foods UPC: 20826766840025 Sold at Amazon Stores and Whole Foods Stores | GH Foods CA LLC | Food | Class I | 6 |
| 22 Dec 2020 | 9" French Silk Base, Item 7545, Count per case 6 Ea., Case Weight 12 lb. 3 oz. UPC 50796220075458. Keep Frozen. (87045) | American Blue Ribbon Holdings LLC | Food | Class I | 1 |
| 22 Dec 2020 | Party Tray Vegetables with Ranch Dip, packaged in 40 oz (2.5 LBS) plastic tray with lid, UPC 3825911509. (87043) | Country Fresh Orlando, LLC | Food | Class II | 1 |
| 22 Dec 2020 | OUR SPECIALTY; Cake Truffles; Variety; Chocolate; Cookies 'N Creme; NO: Artificial Colors, Flavors, or High Fructose Corn Syrup; Net Wt. 19.5 oz(1 LB 3.5 oz) (552 g) | Rich Products Corp | Food | Class II | 1 |
| 21 Dec 2020 | Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 21 Dec 2020 | Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01 (87018) | Individual firm, name withheld | Drug | Class II | 1 |
| 21 Dec 2020 | Material Number: 7002 3/8 Diced Green Chile INGREDIENTS: Green Chilies, Citric Acid PRODUCT OF: MEXICO UNIT OF MEASURE: 440 +/- 5 LBS packaged in 50- gallon plastic drum, 4 drums per pallet (87024) | SUN VALLEY FOODS LLC | Food | Class II | 1 |
| 18 Dec 2020 | Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. (86702) | Laerdal Medical (Suzhou) Co., Ltd. | Device | Class II | 1 |
| 18 Dec 2020 | AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the… (87057) | Ansh Labs, LLC | Device | Class II | 1 |
| 18 Dec 2020 | Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01 | KVK-Tech, Inc. | Drug | Class III | 1 |
| 18 Dec 2020 | SPUD-QUEEN LATTICE CUT - SKIN ON FROZEN POTATOES, master case SKU 10071179 041290. Distributed by Mid America Potato Company P.O. BOX 9386 BOISE, ID. Each case contains 6/4.5 lbs. packages (net wt. 27 lbs.). Product is a foodservice item and product is packaged in a clear bag and has no label. The Master Case label… (87015) | Individual firm, name withheld | Food | Class I | 1 |
| 17 Dec 2020 | EXOGEN Ultrasound Coupling Gel (87002) | Bioventus, LLC | Device | Class II | 1 |
| 17 Dec 2020 | A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001 | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 17 Dec 2020 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02 | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 17 Dec 2020 | Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979 | Imprimis NJOF, LLC | Drug | Class II | 1 |
| 17 Dec 2020 | Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88 | Ascend Laboratories LLC | Drug | Class II | 2 |
| 17 Dec 2020 | Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006 | SCA Pharmaceuticals | Drug | Class II | 32 |
| 17 Dec 2020 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34 | CIPLA | Drug | Class II | 3 |
| 16 Dec 2020 | Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707 (86965) | Cook Medical Llc | Device | Class II | 1 |
| 16 Dec 2020 | REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity. | Individual firm, name withheld | Device | Class II | 3 |
| 16 Dec 2020 | Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032 | US Compounding Inc | Drug | Class III | 1 |
| 16 Dec 2020 | Trader Joe's Lightly Salted Edamame: Fully Cooked Soybeans in Pod. Keep Frozen NET WT 16 oz. (1 lb.) 454 g UPC: 0051 0639 Ingredients: Edamame (soybeans), salt Heating: microwave (1200 watt); Microwave cook times may vary depending on oven wattage. Open and pour into a microwave safe dish; heat 3-4 minutes at 50%… (87003) | TESOROS TRADING CO. | Food | Class I | 1 |
| 16 Dec 2020 | HRV Carrot.Cubes 1/20LB/HRV DCD Cartos 1/20LB - bag in box product in a corrugated case; IQF Cartotte Cubes 3/8" 1/25LB/IQF Diced Cartos 3/8" 1/25LB - bag in box product in corrugated case; Classic Carot Cubes 12/2LB/Classic DCD Carrots 12/2LB - corrugated cases of 12 individual printed poly bags | Bonduelle Canada Inc. | Food | Class II | 3 |
| 15 Dec 2020 | PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45 | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 15 Dec 2020 | ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned. | Boston Scientific Corporation | Device | Class II | 1 |
| 15 Dec 2020 | VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292 | Ortho Clinical Diagnostics Inc | Device | Class II | 2 |
| 15 Dec 2020 | Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the… | Penumbra Inc. | Device | Class I | 4 |
| 15 Dec 2020 | Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 11 Dec 2020 | VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 11 Dec 2020 | Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments, such as forceps and clamps, theatre… | Steris Corporation | Device | Class II | 1 |
| 11 Dec 2020 | VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT… | Ortho Clinical Diagnostics Inc | Device | Class II | 1 |
| 11 Dec 2020 | NETUNO Caribbean Red Snapper, Net Weight 10 Lbs (4.54 Kg), Item 101229, Product Must be Fully Cooked Prior to Consumption, 1.5-2.0 LB (86987) | Netuno USA, Inc. | Food | Class II | 1 |
| 10 Dec 2020 | GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. | GE Healthcare, LLC | Device | Class II | 6 |
| 10 Dec 2020 | Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by… (86952) | Individual firm, name withheld | Device | Class II | 1 |
| 10 Dec 2020 | Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049 | Remel Inc | Device | Class II | 1 |
| 10 Dec 2020 | TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. | Accuray Incorporated | Device | Class II | 2 |
| 8 Dec 2020 | BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448605 (Discontinued) | Becton Dickinson & Co. | Device | Class II | 8 |
| 8 Dec 2020 | Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures. | The Magstim Company Limited | Device | Class II | 1 |
| 8 Dec 2020 | Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001 | Roche Diagnostics Operations, Inc. | Device | Class II | 2 |
| 8 Dec 2020 | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. | Individual firm, name withheld | Device | Class II | 3 |
| 5 Dec 2020 | visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization. (87049) | VISBY MEDICAL INC | Device | Class II | 1 |
| 4 Dec 2020 | Darlington's Soft Baked Cookies, Sugar Free Net Wt. 0.75 oz (21 g), Darlington, Noblesville, IN (86931) | HS Baking Enterprises LLC DBA Darlington Manufacturing | Food | Class III | 1 |
| 2 Dec 2020 | CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48… | Roche Diagnostics Operations, Inc. | Device | Class II | 2 |
| 2 Dec 2020 | Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031 | Steris Corporation | Device | Class II | 14 |
| 2 Dec 2020 | Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 3 |
| 1 Dec 2020 | AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution. | Boston Scientific Corporation | Device | Class II | 6 |
| 1 Dec 2020 | Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02 | GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION | Drug | Class II | 2 |
| 30 Nov 2020 | Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 27 Nov 2020 | Multigrain Solene Figotte, prebaked frozen breads with seeds, Item 29497, Net Weight 8.8 Lbs (4 Kg), Lot: 1234567, UPC code (01)03604380294973(10)1234567(15)191121(91)0309000001, (86874) | Landert LLC | Food | Class II | 1 |
| 25 Nov 2020 | Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05 | US Compounding Inc | Drug | Class III | 1 |
| 24 Nov 2020 | SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 23 Nov 2020 | cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 23 Nov 2020 | uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 23 Nov 2020 | Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 11 |
| 23 Nov 2020 | Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S | Covidien Llc | Device | Class II | 2 |
| 23 Nov 2020 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054 | Ascend Laboratories LLC | Drug | Class II | 1 |
| 20 Nov 2020 | enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate… | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 2 |
| 20 Nov 2020 | HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035 | Complete Pharmacy and Medical Solutions, LLC. | Drug | Class II | 4 |
| 19 Nov 2020 | CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set). (86825) | Lidco Ltd | Device | Class II | 1 |
| 19 Nov 2020 | The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system.… | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 19 Nov 2020 | Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing. | Steris Corporation | Device | Class II | 1 |
| 19 Nov 2020 | Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. | Philips North America, LLC | Device | Class II | 1 |
| 17 Nov 2020 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904 | Boston Scientific Corporation | Device | Class I | 6 |
| 16 Nov 2020 | Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570 | Boston Scientific Corporation | Device | Class II | 2 |
| 13 Nov 2020 | EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD) | Boston Scientific Corporation | Device | Class I | 1 |
| 13 Nov 2020 | Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries. | Medline Industries Inc | Device | Class II | 5 |
| 12 Nov 2020 | CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000 | Medtronic Inc. | Device | Class II | 1 |
| 12 Nov 2020 | Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy. (86872) | Individual firm, name withheld | Device | Class II | 1 |
| 11 Nov 2020 | Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a… | Intersurgical Inc | Device | Class II | 1 |
| 11 Nov 2020 | REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. | Westmed, Inc. | Device | Class II | 6 |
| 10 Nov 2020 | Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation… | Merit Medical Systems, Inc. | Device | Class II | 3 |
| 10 Nov 2020 | MiniCap Extended Life PD Transfer Set | Baxter Healthcare Corporation | Device | Class II | 1 |
| 9 Nov 2020 | icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. | ICU Medical, Inc. | Device | Class II | 1 |
| 9 Nov 2020 | Equinoxe Humeral Stem, Primary, Press Fit, 11mm | Exactech, Inc. | Device | Class II | 1 |
| 9 Nov 2020 | Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE, Item 800003011, Lot #… | ROi CPS LLC | Device | Class II | 1 |
| 7 Nov 2020 | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 19 |
| 2 Nov 2020 | Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture; | Smith & Nephew, Inc. | Device | Class II | 1 |
| 27 Oct 2020 | All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 100-240V… | Philips Ultrasound Inc | Device | Class II | 1 |
| 25 Sep 2020 | Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5 | Wishgarden Herbs, Incorporated | Drug | Class I | 3 |
| 11 Sep 2020 | Synapse PACS Software Versions 5.1 and higher | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 9 Sep 2020 | Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery). | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 19 Mar 2020 | Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505 | Edge Pharma, LLC | Drug | Class II | 1 |
| 19 Mar 2020 | Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not… | Edge Pharma, LLC | Drug | Class II | 1 |
| 13 Nov 2019 | Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Eleganza 5 is a positionable bed for intensive care. Its purpose is to support patient and to facilitate treatment and manipulation with patient for nursing personnel. | Linet Spol. S.r.o. | Device | Class II | 1 |
| 6 Jun 2019 | OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. | Skeletal Kinetics, Llc | Device | Class II | 2 |