| 14 May 2020 | Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05. | InvaGen Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 13 May 2020 | Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25. | West-Ward Columbus Inc | Drug | Class III | 1 |
| 13 May 2020 | Willamette Valley Pie Company Raspberry Rhubarb Pie, packaged in clamshells container, six containers per case. Each pie weighs 10 oz. and sold as individual pies to consumers. UPC: 0 22518 87931 2. The label on a clamshell container is read in parts: "***HANDMADE All-Natural Raspberry Rhubarb Pie ***BAKED & READY TO… | Willamette Valley Pie Company, LLC. | Food | Class II | 2 |
| 12 May 2020 | Peekaboo Ice Cream + hidden Veggies; Organic Mint Chocolate Chip with Hidden Spinach, 14 oz. carton: UPC: 868540000115 Manufactured for: Peekaboo Organics LLC, Surfside, FL. 33154 Certified Organic by QCS Event 85659 | Ramar International Corporation | Food | Class I | 1 |
| 8 May 2020 | LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09 | ICU Medical Inc | Drug | Class I | 1 |
| 5 May 2020 | Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50 | Mylan Institutional LLC | Drug | Class II | 1 |
| 4 May 2020 | The product is twisted bread and packaged in a flexible plastic bag with a yellow Kwik-Lok seal. The label is read in parts: "***ORGANIC SLICED COLUMBIA*** Net Weight 32 ounces *** The ESSENTIAL BAKING Company***INGREDIENTS: Organic Unbleached Wheat Flour, Water, Organic Whole Wheat Flour, Organic Rye Flour, Sea… Event 85614 | Essential Baking Company, The | Food | Class II | 1 |
| 4 May 2020 | Lay's Smooth Ranch dip 15 oz. UPC 2840007095 packaged in clear glass jars | Frito-Lay, Inc. | Food | Class II | 4 |
| 1 May 2020 | Optavia, Old Fashioned Maple & Brown Sugar Oatmeal . 1.13 oz./ 32 g pouch, Multi-layer Kraft paper/aluminum pouches, Seven pouches per carton Event 85604 | Jason Pharmaceuticals, Inc. t/a Medifast | Food | Class I | 1 |
| 30 Apr 2020 | Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. | Covidien Llc | Device | Class II | 11 |
| 29 Apr 2020 | RICKER HILL ORCHARDS APPLE CIDER McIntosh Blend, 1 GAL (128 FL OZ) and 1/2 GAL (64 FL OZ); UPC: 0 74613 80009 8; MADE IN MAINE; KEEP REFRIGERATED; Produced by Ricker Hill Orchards, Turner, ME 04282 Event 85589 | Ricker Hill Farms, Inc. | Food | Class II | 1 |
| 28 Apr 2020 | Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G UPC 886790018872 | Glaxosmithkline Consumer Healthcare Holdings | Food | Class II | 2 |
| 27 Apr 2020 | 43237 ROLL chicken salad on croissant single, vacuumed pack bag, Clam shell. Label UPC: 50777445351, Condies Foods Inc. PO Box 18548. Salt Lake City, UT. | Condies Foods, Inc. | Food | Class I | 2 |
| 25 Apr 2020 | Joseph's Gluten Free Original Wrap, 4 wraps, Net. Wt. 5.6 oz., UPC Code: 074117-003612 | Middle East Bakery, Inc. | Food | Class II | 1 |
| 24 Apr 2020 | DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line Tray Pgybk, 89-6150.12 d. Umbilical Arterial Cath, 89-9370.01 e. Port Pack Pgybk, 89-8748.03 f. Port Pack Pgybk, 89-8748.04… | DeRoyal Industries Inc | Device | Class II | 1 |
| 24 Apr 2020 | Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61 | The Harvard Drug Group | Drug | Class III | 1 |
| 24 Apr 2020 | Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10 Event 85557 | Name withheld | Drug | Class III | 1 |
| 23 Apr 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a… | Access Scientific LLC | Device | Class II | 12 |
| 22 Apr 2020 | TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE; Assorted dried fruits; NET WT 17.63 oz (500g) clear plastic package Event 85546 | Royal International Trading Inc. | Food | Class I | 1 |
| 21 Apr 2020 | Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0 | Sandoz, Inc | Drug | Class II | 1 |
| 20 Apr 2020 | B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma. | Cardinal Health Inc. | Device | Class II | 3 |
| 20 Apr 2020 | Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures. | Bovie Medical Corporation | Device | Class II | 2 |
| 20 Apr 2020 | Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 20 Apr 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08 | Glaxosmithkline Consumer Healthcare Holdings | Drug | Class III | 3 |
| 20 Apr 2020 | 5.5 oz cans of Ocean Spray Pink Lite Cranberry Juice Drink Event 85523 | Ocean Spray Cranberries Inc. | Food | Class II | 1 |
| 20 Apr 2020 | 12", 10" Pressed Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery. | La Sonorense, Inc. | Food | Class II | 3 |
| 18 Apr 2020 | Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11 | B. Braun Medical Inc | Drug | Class I | 1 |
| 18 Apr 2020 | Wegmans brand Semi-Sweet Chocolate Nonpareils in an 18.5 oz. (524 g) plastic container, 12 plastic containers per case. Event 85539 | Name withheld | Food | Class I | 1 |
| 17 Apr 2020 | 7126763 Flounder Stuffed W/ Seafood FRZN, Net Wt LBS 3.00 (1.36 KG), 4 packages per case | Freedman Food Service, Inc dba Buckhead Meat & Seafood of Houston | Food | Class I | 2 |
| 16 Apr 2020 | Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The | Elekta Inc | Device | Class II | 1 |
| 16 Apr 2020 | BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535 | Becton Dickinson & Company | Device | Class II | 1 |
| 16 Apr 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17) | Howmedica Osteonics Corp. | Device | Class II | 16 |
| 16 Apr 2020 | Whole Foods Market Queso Sauce PLU code printed on the product scale labels beginning with 74135 sold in clear plastic deli-style containers of various weights. | Whole Foods Market | Food | Class I | 1 |
| 15 Apr 2020 | Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. The stent is positioned between two… | Cook Inc. | Device | Class II | 1 |
| 15 Apr 2020 | SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the… | C.R. Bard Inc | Device | Class II | 1 |
| 15 Apr 2020 | Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15 | Amneal Pharmaceuticals of New York, LLC | Drug | Class II | 1 |
| 15 Apr 2020 | Dole "Classic Kit Light Cesar" fresh salad mix. Salad and topping Net Wt.7.7 OZ (218g), Dressing Net 2.2 FL OZ (65ml), Total Net Wt. 10 OZ (283g), Thoroughly Washed, Perishable/Keep Refrigerated. | Dole Fresh Vegetables Inc | Food | Class III | 2 |
| 14 Apr 2020 | BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method. | Becton Dickinson & Co. | Device | Class II | 3 |
| 14 Apr 2020 | Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419. | MasterPharm LLC | Drug | Class I | 1 |
| 13 Apr 2020 | Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a… | Philips North America, LLC | Device | Class II | 1 |
| 13 Apr 2020 | Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193 | Ivoclar Vivadent AG | Device | Class II | 4 |
| 13 Apr 2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 10888857108202, Size 24x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | K2M, Inc | Device | Class II | 24 |
| 10 Apr 2020 | HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life… | Philips North America, LLC | Device | Class II | 1 |
| 10 Apr 2020 | Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. | Philips North America, LLC | Device | Class II | 2 |
| 10 Apr 2020 | Whole Foods Market Minestrone Soup PLU code printed on the product scale labels beginning with 248529 for soup sold in clear plastic deli-style containers of various weight and 246691 for soup sold in clear plastic bags weighing 7 lbs. 12 oz. | Whole Foods Market | Food | Class I | 1 |
| 9 Apr 2020 | The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 9 Apr 2020 | WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. | Wright Medical Technology Inc | Device | Class II | 1 |
| 9 Apr 2020 | BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on… | Name withheld | Device | Class II | 3 |
| 8 Apr 2020 | Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label: Arterial Line Kit 20ga x 3", Ref 498411B,… | Argon Medical Devices, Inc | Device | Class II | 3 |
| 7 Apr 2020 | Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation. | Innovasis, Inc | Device | Class II | 1 |
| 7 Apr 2020 | Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults). | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 7 Apr 2020 | Prismaflex Control Unit | Baxter Healthcare Corporation | Device | Class II | 1 |
| 7 Apr 2020 | Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography. | Philips North America, LLC | Device | Class II | 1 |
| 7 Apr 2020 | Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.… | Name withheld | Device | Class II | 2 |
| 7 Apr 2020 | Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. | Maquet Cardiovascular, LLC | Device | Class II | 24 |
| 7 Apr 2020 | Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf | Name withheld | Device | Class II | 3 |
| 6 Apr 2020 | Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848 | Philips North America, LLC | Device | Class II | 3 |
| 6 Apr 2020 | System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and… | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 6 Apr 2020 | Biotin 1000mcg, Dietary Supplement, 30 Tablets, Manufactured by: Golden Nutrition Event 85496 | GOLDEN NUTRITION INC | Food | Class III | 1 |
| 3 Apr 2020 | Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger than 25cm2. CRANIO/SCULPT C may be used in… | Skeletal Kinetics, Llc | Device | Class II | 1 |
| 3 Apr 2020 | Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079 | Philips North America, LLC | Device | Class II | 1 |
| 3 Apr 2020 | Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures. | Pega Medical Inc. | Device | Class III | 1 |
| 3 Apr 2020 | ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options Event 85475 | Immersivetouch Inc | Device | Class III | 1 |
| 1 Apr 2020 | ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. | Abbott Laboratories | Device | Class III | 3 |
| 1 Apr 2020 | VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction. | Ortho-Clinical Diagnostics | Device | Class II | 2 |
| 1 Apr 2020 | Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 1 Apr 2020 | XinXing Dried Plum, Net Wt. 5.3 oz.(150g) | Rong Shing Trading NY Inc | Food | Class III | 1 |
| 1 Apr 2020 | Homestead Creamery Unsalted Butter. 0.45 lb. net weight. 1 unit per package, cellophane wrap | Homestead Creamery, Inc. | Food | Class I | 1 |
| 31 Mar 2020 | Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC brand flow cytometer. The flow… | Becton, Dickinson and Company, BD Biosciences | Device | Class II | 1 |
| 30 Mar 2020 | Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument | Elekta Inc | Device | Class II | 1 |
| 30 Mar 2020 | MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. | Boston Scientific Corporation | Device | Class II | 1 |
| 30 Mar 2020 | iChem VELOCITY Urine Chemistry System- | Beckman Coulter Inc. | Device | Class II | 2 |
| 27 Mar 2020 | Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181 | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 26 Mar 2020 | CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986 | Becton Dickinson & Company | Device | Class II | 1 |
| 26 Mar 2020 | VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 26 Mar 2020 | Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 26 Mar 2020 | Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns,… | Gentell, Inc | Device | Class II | 4 |
| 24 Mar 2020 | CALCI-MAX Dietary Supplement, 60 capsules, Manufactured for: DOMEL Event 85317 | Alfa Vitamins Laboratories, Inc. | Food | Class III | 1 |
| 23 Mar 2020 | Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. | The Magstim Company Limited | Device | Class II | 2 |
| 23 Mar 2020 | Natural by Nature 1 % Milk (gallon, 1/2 gallon, and quart) | Natural Dairy Products | Food | Class II | 3 |
| 18 Mar 2020 | Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms. | WELCH ALLYN, INC/MORTARA | Device | Class II | 10 |
| 18 Mar 2020 | Frames Direct Prescription Spectacle Lenses included in the frame brands Event 85484 | Frames Direct | Device | Class II | 1 |
| 17 Mar 2020 | PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D | Becton Dickinson & Company | Device | Class II | 1 |
| 16 Mar 2020 | Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies | Vascular Solutions, Inc. | Device | Class I | 1 |
| 16 Mar 2020 | CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit | Avanos Medical, Inc. | Device | Class II | 1 |
| 11 Mar 2020 | PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 10 Mar 2020 | VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 | Ortho Clinical Diagnostics | Device | Class III | 1 |
| 10 Mar 2020 | Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi. | Northgate Technologies, Inc. | Device | Class II | 3 |
| 9 Mar 2020 | Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK… | Medline Industries Inc | Device | Class II | 1 |
| 6 Mar 2020 | ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 | Radiometer Medical ApS | Device | Class II | 1 |
| 6 Mar 2020 | TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system. | Cardiac Assist, Inc | Device | Class II | 8 |
| 6 Mar 2020 | Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830 | R82 A/S | Device | Class II | 1 |
| 5 Mar 2020 | Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. | Philips North America, LLC | Device | Class II | 1 |
| 5 Mar 2020 | Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 3 Mar 2020 | Tops Mint Flavor Pure Dark Chocolate 45% Cocoa NET WT 3.5 oz.(100g) Event 85377 | Tops Markets Inc. | Food | Class II | 1 |
| 28 Feb 2020 | Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid pressure and/or collect cerebrospinal fluid specimens. Key components include skin prep materials, lancet-point needle, manometer with… | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 27 Feb 2020 | Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 26 Feb 2020 | BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025 | Becton Dickinson & Company | Device | Class II | 8 |
| 25 Feb 2020 | Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments. | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical | Device | Class II | 1 |
| 21 Feb 2020 | R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain. | Epimed International | Device | Class II | 2 |
| 17 Feb 2020 | AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve. | Advanced Bionics, LLC | Device | Class II | 2 |
| 14 Feb 2020 | The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated… | ICU Medical, Inc. | Device | Class II | 1 |
| 13 Feb 2020 | Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966). | Sunrise Medical (US) LLC | Device | Class II | 1 |
| 13 Feb 2020 | NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and Armada fixation components (i.e. Pedicle screws, hooks and/or connectors, provided non-sterile, to be… | NuVasive Inc | Device | Class II | 1 |
| 13 Feb 2020 | DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral… | Merit Medical Systems, Inc. | Device | Class II | 2 |
| 11 Feb 2020 | NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T Event 85343 | Nelson Innovaions, Llc | Device | Class II | 1 |
| 6 Feb 2020 | Prismaflex System, Prismaflex Control Unit | Baxter Healthcare Corporation | Device | Class II | 6 |
| 31 Jan 2020 | STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. | Applied Medical Resources Corp | Device | Class II | 4 |
| 15 Jan 2020 | BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the… | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 14 Jan 2020 | BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. | CME America, LLC | Device | Class II | 1 |
| 7 Jan 2020 | Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282 | Stryker Corporation | Device | Class II | 2 |
| 2 Jan 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4 | ICU Medical, Inc. | Device | Class II | 7 |
| 17 Dec 2019 | Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta. | W L Gore & Associates, Inc. | Device | Class II | 1 |
| 17 Dec 2019 | AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). | Boston Scientific Corporation | Device | Class II | 1 |
| 4 Dec 2019 | 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO | Argon Medical Devices, Inc | Device | Class I | 2 |
| 3 Dec 2019 | Lunar iDXA bone densitometer | GE Healthcare, LLC | Device | Class II | 4 |
| 18 Nov 2019 | Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ. | W. L. Gore & Associates Inc. | Device | Class II | 1 |
| 18 Nov 2019 | ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software | Viewray, Inc. | Device | Class II | 1 |
| 5 Nov 2019 | Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800. | Dako Denmark A/S | Device | Class II | 1 |
| 24 Oct 2019 | Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483 | Applied Medical Resources Corp | Device | Class I | 3 |
| 22 Oct 2019 | EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease including… | Encore Medical, LP | Device | Class II | 1 |
| 18 Oct 2019 | CapsoCAM Plus, UDI: 00867770000209 | Capso Vision, Inc. | Device | Class II | 1 |
| 15 Oct 2019 | CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 Event 85446 | Cuattro LLC | Device | Class II | 1 |
| 10 Oct 2019 | 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion | Trilliant Surgical, LLC | Device | Class II | 1 |
| 9 Oct 2019 | Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected duration of less than 90 minutes when… | Stryker Sustainability Solutions | Device | Class II | 1 |
| 7 Oct 2019 | Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation. | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 7 Oct 2019 | TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF85-32-81-90. | Baylis Medical Company Inc. | Device | Class II | 2 |
| 4 Oct 2019 | REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475 | ICU Medical, Inc. | Device | Class II | 10 |
| 19 Sep 2019 | Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 19-092400-041, USE BY:… | Ra Medical Systems, Inc. | Device | Class II | 1 |
| 18 Sep 2019 | iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System | Boston Scientific Corporation | Device | Class II | 1 |
| 12 Sep 2019 | Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 30 Aug 2019 | Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies | Philips Ultrasound Inc | Device | Class II | 4 |
| 28 Aug 2019 | NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function. | Nobel Biocare Usa Llc | Device | Class II | 1 |
| 12 Aug 2019 | Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes… | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 9 Aug 2019 | Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain… | Medtronic Navigation, Inc. | Device | Class I | 1 |
| 9 Aug 2019 | Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. | Nobel Biocare Usa Llc | Device | Class II | 6 |
| 6 Aug 2019 | Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system. | Clinical Innovations, LLC | Device | Class II | 1 |
| 16 Jul 2019 | Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected… | TeDan Surgical Innovations LLC | Device | Class II | 1 |
| 12 Jul 2019 | ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499 | ICU Medical, Inc. | Device | Class II | 1 |
| 8 Jul 2019 | Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 3 Jul 2019 | CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel. | Capso Vision, Inc. | Device | Class II | 1 |
| 1 Jul 2019 | daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 12 Jun 2019 | SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine at a cutoff value… | Beckman Coulter Inc. | Device | Class II | 1 |
| 30 May 2019 | Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. | Ortho Development Corporation | Device | Class II | 2 |
| 28 May 2019 | SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device. | Medline Industries Inc | Device | Class II | 3 |
| 23 May 2019 | Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon… Event 85050 | Obalon Therapeutics Inc | Device | Class II | 1 |
| 11 Apr 2019 | da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to support the… | Intuitive Surgical Inc | Device | Class II | 2 |
| 10 Apr 2019 | ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced. Event 85486 | Uromedica Inc. | Device | Class II | 1 |
| 3 Apr 2019 | Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings. Event 85074 | Bio-Rad Labs | Device | Class II | 1 |
| 3 Apr 2019 | Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile | Delfi Medical Innovations, Inc. | Device | Class II | 2 |
| 30 Jan 2019 | Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each… Event 84989 | U&I CORP. | Device | Class II | 1 |
| 9 Jan 2019 | Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10 Event 85388 | Name withheld | Device | Class III | 1 |
| 4 Jan 2019 | SWIN 2017 database, Model YSW4000 | Remel Inc. | Device | Class II | 1 |
| 21 Nov 2018 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 25 Oct 2018 | da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 1 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. Event 84839 | Allied Vision Group Inc | Device | Class II | 1 |
| 27 Jun 2018 | Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction. | Genicon, Inc. | Device | Class II | 1 |
| 28 Oct 2016 | Simply Nature Organic Green Lentils, 16 oz bag, UPC 041498299514 | Aldi Inc | Food | Class II | 2 |
| 15 Jun 2016 | EVA Floor Lifts, Model Numbers: 400, 450, 600 | Handicare AB | Device | Class II | 1 |