| 19 Mar 2021 | Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10 | Golden State Medical Supply Inc. | Drug | Class II | 1 |
| 18 Mar 2021 | Gelson's Yogurt Raisins, Plastic Clamshell Container NET WT 14 oz. (397g) UPC: 7 97565 20470 6 Contains: Milk, Soy. Packed in a facility that handles Peanuts, Tree Nuts, Wheat, Soy, Egg, and Milk products. Product of USA, Distributed by Gelson's, Encino, CA | Western Mixers Produce & Nuts, Inc. | Food | Class I | 1 |
| 12 Mar 2021 | Buc-ee's Butter Toffee Almonds, 12 oz., packaged in clear zip top bag with stickered label, UPC: 0 9524842002 4, Manufactured and packaged at Lehi Valley Trading Company 4955 . McKellips Rd, Mesa, AZ 85215. branded and statement on label "Distributed by Buc-ee's LTD. 327 FM 2004 Lake Jackson, TX 77566. Store in… (87536) | Lehi Valley Trading Co, Inc | Food | Class II | 1 |
| 11 Mar 2021 | Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01. | Sagent Pharmaceuticals Inc | Drug | Class II | 1 |
| 11 Mar 2021 | Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10 | Breckenridge Pharmaceutical, Inc | Drug | Class II | 1 |
| 11 Mar 2021 | Mindo COFFEE TOFFEE CHOCOLATE BAR, 75 gram / 2.65oz UPC code 805993900527. Also sold in 12 count and 6 count cartons (87543) | Mindo Chocolate Makers LLC | Food | Class II | 1 |
| 9 Mar 2021 | 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09 | ICU Medical Inc | Drug | Class II | 1 |
| 8 Mar 2021 | Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07 | Akorn, Inc. | Drug | Class II | 1 |
| 5 Mar 2021 | Hu***CHOCOLATE-COVERED HUNKS SOUR GOLDENBERRIES***Net Wt. 4 oz (113g); packaged in a black bag; Distributed by: Hu Products LLC, NY, NY 10011 | HU PRODUCTS | Food | Class II | 1 |
| 4 Mar 2021 | Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01 | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 3 Mar 2021 | Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 3 Mar 2021 | RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 2 Mar 2021 | Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-2; b) Professional Sample Kit: 3 single dose vials of Menotropins for injection, 3 single dose vials of 0.9% Sodium Chloride… | Ferring Pharmaceuticals Inc | Drug | Class III | 1 |
| 2 Mar 2021 | Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 6191985330 | Direct Rx | Drug | Class II | 1 |
| 2 Mar 2021 | Amazon Kitchen, Avocado Chicken Salad Sandwich, Net Wt. 8.1 oz., Cello wrap with cardboard liner, 1 unit per package, Perishable Keep Refrigerated | Flying Food Group LLC | Food | Class I | 1 |
| 1 Mar 2021 | Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic,… | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 1 Mar 2021 | ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). | Brainlab AG | Device | Class II | 1 |
| 27 Feb 2021 | Nutrin/Amendobras brand Roasted Peanut Splits packaged in 30lb cardboard boxes. (87469) | Nutrin Distribution Co | Food | Class I | 1 |
| 26 Feb 2021 | CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology. (87445) | CAIRE DIAGNOSTICS INC | Device | Class II | 1 |
| 26 Feb 2021 | CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. | Accuray Incorporated | Device | Class II | 1 |
| 26 Feb 2021 | Interventional Fluoroscopic X-Ray System - Product Usage: developed 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 |
| 26 Feb 2021 | Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures. | Biosense Webster, Inc. | Device | Class II | 3 |
| 26 Feb 2021 | Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01. (87411) | Individual firm, name withheld | Drug | Class II | 1 |
| 26 Feb 2021 | Electrolit Ponche/Fruit Punch; in 625 mL/21 oz and 300ML/10oz bottles; and Electrolit Fruit Punch 6 Pack, 625mL/21 oz; Packaged in a polypropylene bottle with volume capacity 625 mL and a polypropylene lid and liner with a high-density polyethylene safety ring. | Laboratorios Pisa Sa De Cv | Food | Class III | 2 |
| 26 Feb 2021 | Item #140804, Egg Salad Croissant Sandwich, Refrigerated, packaged in clear plastic clamshell container. Ready to Eat product sold in foodservice, retail, and deli stores. Net wt. 6.6 OZ (187g). UPC 0 30223 10915 0. The label is read in parts: "***Egg Salad Croissant Sandwich***INGREDIENTS *** EGG SALAD***BUTTER… | Taylor Farms Northwest, LLC | Food | Class II | 3 |
| 26 Feb 2021 | Old Cape Cod Soup and Chowder Oyster Crackers - 8oz Box, 12 per case - UPC 093215801005; Westminster Bakers Co. Soup & Snack Crackers - 8oz Box, 12 per case - UPC 093215200426; Westminster Bakers Co. Soup & Snack Crackers - 8oz Box, 6 per case - UPC 093215200426 (87413) | Westminster Cracker Inc. | Food | Class II | 1 |
| 25 Feb 2021 | In-View Clear Leggings Sterile | Cardinal Health 200, LLC | Device | Class II | 5 |
| 25 Feb 2021 | Tahina Sesame Paste packaged in 1lb and 2lb plastic jars and 10kg metal containers; UPC CODES 6215000382207 (87438) | KAREEM MART INC | Food | Class I | 1 |
| 24 Feb 2021 | Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body. | Philips Healthcare (Suzhou) Co., Ltd. | Device | Class II | 1 |
| 24 Feb 2021 | Alqosh Sesame Oil "Tahin" packaged in 2lb plastic jars (87437) | Mediterranean Food, Inc. | Food | Class I | 1 |
| 22 Feb 2021 | Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01 | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 22 Feb 2021 | SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use. (87393) | Sirtex Medical Limited | Device | Class II | 1 |
| 22 Feb 2021 | Incisive CT Computed Tomography X-ray System Model: 728143 | Philips North America Llc | Device | Class II | 1 |
| 22 Feb 2021 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class III | 1 |
| 19 Feb 2021 | Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03 | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 19 Feb 2021 | Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3. | Noven Pharmaceuticals Inc | Drug | Class II | 4 |
| 19 Feb 2021 | Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA (87365) | Individual firm, name withheld | Drug | Class III | 1 |
| 19 Feb 2021 | Java Frozen Tuna Steaks - 10 oz. Net Wt. 10 lb. - Approximately 15-18 pieces individually vacuum packed. Product of Indonesia - Wild Caught. (87378) | Seafood Imports Distributors Inc. | Food | Class I | 1 |
| 19 Feb 2021 | Coolhaus Awesome Dessert - Dairy Free Mocha Marcona Almond Fudge, Creamy Coffee Fudge Swirl & Marcona Almond Frozen Dessert. 16 fl.oz, Dessert Paperboard Pint (473 mL) UPC: 851916003605 Coolhaus Headquarters, Culver City, CA Contains Statement: Tree nuts, Coconut | COOLHAUS | Food | Class II | 1 |
| 19 Feb 2021 | YUM CRUMBS, STRAWBERRY SHORTCAKE, 12 oz and 32 oz (87405) | THE SAPPHIRE EXCHANGE | Food | Class III | 1 |
| 19 Feb 2021 | Urban Remedy Organic Cacao Mocha Cold Brew Coffee; 16 FL. OZ (473 mL) UPC" 8 13377 02222 9 Ingredients: Cashew Milk (filtered water, cashew, Date syrup, Vanilla Extract, Himalayan Pink Salt) Cold Brew Coffee (filtered water, coffee bean), Cacoa Powder Contains: Cashew | Individual firm, name withheld | Food | Class II | 2 |
| 19 Feb 2021 | Al-Riyan Tuna Meat in Vegetable oil 7 oz. can 48 cans per case (87417) | GREEN CITY DISTRIBUTION | Food | Class II | 1 |
| 18 Feb 2021 | RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation. | TELEFLEX MEDICAL INC | Device | Class II | 1 |
| 18 Feb 2021 | SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing… | Sunstar Americas, Inc. | Device | Class II | 1 |
| 18 Feb 2021 | VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current… | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 1 |
| 18 Feb 2021 | Ferrara Candy Company assorted candy Heart Box, including Laffy Taffy, Nerds, and SweeTarts candies. 10 retail units per wholesale case. Package UPC 0 41420 04965 1 (87338) | Ferrara Candy Company | Food | Class III | 1 |
| 17 Feb 2021 | Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 unit-dose) tablets per carton (NDC 43598-344-31); Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540; Made in India. (87339) | Individual firm, name withheld | Drug | Class II | 1 |
| 17 Feb 2021 | Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05 | Edge Pharma, LLC | Drug | Class III | 1 |
| 17 Feb 2021 | Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA NDC 76318-334-50 (87384) | The General Hospital Corporation | Drug | Class II | 1 |
| 17 Feb 2021 | Market District Gourmet Pretzel Gift Bag PLU 45505 Net Wt 9 oz Market District Gourmet Pretzel Platter PLU 25206 Net Wt 48 oz (87368) | Individual firm, name withheld | Food | Class II | 1 |
| 17 Feb 2021 | Quseo Fresco sold under the following brands and container sizes - El Abuelito Cheese Brand - Queso Fresco Regular 12 oz.Plastic Container673130100003 Queso Fresco Promoci¿n 10 oz.Plastic Container673130100078 Queso Fresco de Hoja 12 oz.Plastic Container673130100065 Queso Fresco 5 Lb.Vacuum Packed673130100058 Queso… | El Abuelito Cheese, Inc. | Food | Class I | 3 |
| 15 Feb 2021 | Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions. (87443) | CARESTREAM DENTAL, LLC | Device | Class II | 1 |
| 15 Feb 2021 | Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray) | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 15 Feb 2021 | Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5 | Adams.Secret.co | Drug | Class I | 2 |
| 15 Feb 2021 | MN Milk Bank for Babies Pasteurized Donor Human Milk. Volumne 4.0 fl oz., 120 mL (87337) | Minnesota Milk Bank for Babies | Food | Class III | 1 |
| 13 Feb 2021 | Milk Chocolate Double Dipped Peanuts No Brand Name 7.5oz Non-Flex Plastic Tub (87336) | Tropical Nut & Fruit Inc | Food | Class III | 1 |
| 12 Feb 2021 | PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in straight, right angle, and trocar… | TELEFLEX MEDICAL INC | Device | Class II | 1 |
| 12 Feb 2021 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative… | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 2 |
| 12 Feb 2021 | Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA). | Medtronic Vascular, Inc. | Device | Class I | 1 |
| 12 Feb 2021 | Brite Harbor Caesar Dressing & Dip, 1.5 oz pillows (pouches), item # 16002. The front label states "***BRITE HARBOR CAESAR DRESSING & DIP***" and the back label states "***BLUE CHEESE DRESSING***CONTAINS Egg, Milk ***". | Litehouse Inc | Food | Class II | 1 |
| 11 Feb 2021 | PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC | Cordis Corporation | Device | Class I | 1 |
| 11 Feb 2021 | Operating Table System | Getinge Group Logistics America, LLC | Device | Class II | 1 |
| 11 Feb 2021 | Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 | Imactis | Device | Class II | 1 |
| 11 Feb 2021 | JUDKINS PACK | Cardinal Health 200, LLC | Device | Class II | 1 |
| 11 Feb 2021 | 1. See's Candies brand chocolate 4.5 oz Sitting Bunny (SKU 600738) 2. See's Candies brand 1 oz Bunny (SKU 600741) 3. Gold Foil Balls (SKU 600144) (note: firm also uses the term 'rabbit' interchangeably with 'bunny' however product labeling states bunny or bunnies) (87321) | Thompson Brands LLC | Food | Class I | 1 |
| 10 Feb 2021 | Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer. | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 10 Feb 2021 | Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454. | Teva Pharmaceuticals USA | Drug | Class II | 15 |
| 9 Feb 2021 | In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery. | In2Bones, SAS | Device | Class II | 1 |
| 9 Feb 2021 | Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558 | Cardinal Health 200, LLC | Device | Class II | 3 |
| 9 Feb 2021 | Dole Chopped Kit- Sunflower Crunch Cabbage, Green Leaf Lettuce, Kale, Sunflower Seeds, Sweet Onion and Citrus Dressing, Bacon Crumbles, Red Cabbage, Green onions, carrots. UPC: 0 71430 00034 2 Salad and Toppings Net Wt.:9.5 oz. (269 g) Dressing 2.4 fl oz.(72 mL) Total Net Wt. 12.2 oz. (346 g) Contains: Egg, Soy Dole… | Dole Fresh Vegetables Inc | Food | Class II | 1 |
| 8 Feb 2021 | Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 8 Feb 2021 | Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations. (87318) | Individual firm, name withheld | Device | Class II | 1 |
| 8 Feb 2021 | The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection. | Meridian Bioscience Inc | Device | Class II | 1 |
| 5 Feb 2021 | Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C. | OraSure Technologies, Inc. | Device | Class III | 1 |
| 5 Feb 2021 | System INFX-8000V | Canon Medical System, USA, INC. | Device | Class II | 3 |
| 5 Feb 2021 | Harry & David brand Chocolate Cherries packaged in a clear 3 oz (85g) bag, UPC 7 80994 32341 4. This product is part of the Premium Delights Gift Box, Founders Favorites Gift Box, Valentine s Day Sweets Box, and Tower of Treats¿ Valentine s Day Gift. The Chocolate Cherries label is read in parts: "***CHOCOLATE… | Harry and David Operations Inc | Food | Class I | 1 |
| 5 Feb 2021 | Panang Curry Sauce, 12 fl. oz. (355ml), UPC code #643558406711 | Barbara's Orchard/Delicae Gourmet | Food | Class I | 3 |
| 5 Feb 2021 | Organic fresh cut basil packaged in plastic clamshell containers. Shenandoah Growers by Thats Tasty, 0.75 oz UPC: 7-68573-00101-4 Shenandoah Growers by Thats Tasty, 2.0 oz UPC: 7-68573-02143-2 Shenandoah Growers by Thats Tasty 4.0 oz UPC: 7-68573-00141-0 Shenandoah Growers by Thats Tasty 0.75 oz UPC:… | Shenandoah Growers, Inc. | Food | Class II | 1 |
| 5 Feb 2021 | ALBAHACA ORGANICA/BASIL, 460 gm x Bag, 15 Bags (87303) | VALLARTA ORGANIC LLC | Food | Class II | 1 |
| 4 Feb 2021 | Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal… | Medtronic Perfusion Systems | Device | Class I | 10 |
| 4 Feb 2021 | Aaron's Gourmet Smoked Fish (King, Sockeye, or Steelhead) packaged in glass jars or in vacuum plastic bags. The label on GLASS JAR is read in parts: "***AARON'S GOURMET SMOKED FISH ***Portland Oregon (503) 372-9849 ***Quinault Tribal Seafoods ***Traditional Native American Smoked Wild Salmon***Sockeye***Fully Cooked… (87354) | Aaron's Gourmet Smoked Fish | Food | Class II | 1 |
| 3 Feb 2021 | Thread-like wire marker (87317) | Somatex Medical Technologies GMBH | Device | Class II | 1 |
| 3 Feb 2021 | Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 1 Feb 2021 | Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less | Epimed International, Inc. | Device | Class II | 1 |
| 1 Feb 2021 | Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 (87309) | Individual firm, name withheld | Device | Class II | 1 |
| 1 Feb 2021 | Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland | Insulet Corporation | Device | Class II | 1 |
| 1 Feb 2021 | Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. | Bovie Medical Corporation | Device | Class II | 3 |
| 29 Jan 2021 | S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD… (87331) | Individual firm, name withheld | Device | Class II | 1 |
| 29 Jan 2021 | Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe. | Getinge Group Logistics America, LLC | Device | Class II | 1 |
| 29 Jan 2021 | VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. | Draeger Medical, Inc. | Device | Class II | 4 |
| 28 Jan 2021 | Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). | Baxter Healthcare Corporation | Device | Class II | 4 |
| 28 Jan 2021 | VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and… | Biomerieux Inc | Device | Class II | 2 |
| 28 Jan 2021 | Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. | Olympus Corporation of the Americas | Device | Class II | 1 |
| 27 Jan 2021 | TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag. | Johnson & Johnson Surgical Vision Inc | Device | Class II | 1 |
| 27 Jan 2021 | Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 27 Jan 2021 | Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631. | Meitheal Pharmaceuticals Inc | Drug | Class I | 1 |
| 27 Jan 2021 | Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals | Drug | Class I | 2 |
| 26 Jan 2021 | Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only | BioFire Diagnostics, LLC | Device | Class II | 2 |
| 26 Jan 2021 | Golden Boy Custard Muffin Banana 220 grams/7.76 ounce packages (87222) | Hong Thai Foods Corp | Food | Class I | 1 |
| 25 Jan 2021 | CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades. | DeRoyal Industries Inc | Device | Class II | 3 |
| 25 Jan 2021 | Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs… | Shanghai United Imaging Healthcare Co., Ltd. | Device | Class II | 1 |
| 25 Jan 2021 | Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in… | Corin Ltd | Device | Class II | 2 |
| 25 Jan 2021 | RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement. | Medline Industries Inc | Device | Class II | 1 |
| 22 Jan 2021 | Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY (87288) | Individual firm, name withheld | Device | Class II | 1 |
| 22 Jan 2021 | ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who… | Acist Medical Systems | Device | Class I | 1 |
| 21 Jan 2021 | OT1000 Series Orthopedic Surgical Tables | Steris Corporation | Device | Class II | 1 |
| 21 Jan 2021 | Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm) | CooperSurgical, Inc. | Device | Class II | 1 |
| 21 Jan 2021 | Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more… (87248) | G & H Wire Company | Device | Class II | 1 |
| 20 Jan 2021 | Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia. | R & D Systems, Inc. | Device | Class II | 1 |
| 20 Jan 2021 | Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99 | Aurobindo Pharma USA Inc. | Drug | Class II | 1 |
| 20 Jan 2021 | HOUSE AUTRY TARTAR SAUCE NET WT 9 OZ (255g) DISTSRIBUTED BY House -Autry Mills, Inc. Four Oaks, NC 27524 UPC 0 73484 60013 4 (87194) | House-Autry Mills, Inc | Food | Class III | 1 |
| 19 Jan 2021 | HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that when inserted in the needle… | Merit Medical Systems, Inc. | Device | Class II | 2 |
| 19 Jan 2021 | Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers… (87258) | ReNovo, Inc. | Device | Class II | 1 |
| 19 Jan 2021 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box… | Boston Scientific Corporation | Device | Class II | 3 |
| 18 Jan 2021 | Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient… | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 15 Jan 2021 | S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only. | Medline Industries Inc | Device | Class III | 1 |
| 15 Jan 2021 | ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery). | Northgate Technologies, Inc. | Device | Class II | 2 |
| 15 Jan 2021 | HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400 (87219) | Hamilton Co | Device | Class II | 1 |
| 15 Jan 2021 | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and… | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | Device | Class II | 41 |
| 15 Jan 2021 | Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 | Individual firm, name withheld | Device | Class II | 4 |
| 15 Jan 2021 | One Degree Organic Foods Gluten Free Sprouted Rolled Oats NET WT. 5 lbs (80 oz) 2.27 kg UPC:6 75625 32318 8 (87291) | One Degree Organic Foods Inc, | Food | Class III | 1 |
| 14 Jan 2021 | VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuvettes in combination with sample fluid for Micro Tips Assays. | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 1 |
| 14 Jan 2021 | PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any… | Physio-Control, Inc. | Device | Class II | 1 |
| 14 Jan 2021 | BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 14 Jan 2021 | Publix Steam in Bag Season Butternut Medley | Publix Super Markets, Inc. | Food | Class II | 3 |
| 13 Jan 2021 | Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL | Covidien Llc | Device | Class II | 1 |
| 13 Jan 2021 | ENROUTE Transcarotid Stent System REF SR-XXYY-CS (87196) | Silk Road Medical Inc | Device | Class II | 1 |
| 13 Jan 2021 | Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system. | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 12 Jan 2021 | Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated. (87175) | Natus Manufacturing Limited | Device | Class II | 1 |
| 11 Jan 2021 | Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. | Ecolab Inc | Device | Class II | 1 |
| 8 Jan 2021 | WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI | Nihon Kohden America Inc | Device | Class II | 1 |
| 7 Jan 2021 | The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 6 Jan 2021 | Infusion Pump | Baxter Healthcare Corporation | Device | Class II | 1 |
| 6 Jan 2021 | PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | Respironics California, LLC | Device | Class II | 1 |
| 22 Dec 2020 | Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01 | Edge Pharma, LLC | Drug | Class III | 1 |
| 18 Dec 2020 | ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 18 Dec 2020 | Macey's Kong Popcorn, 24 oz., in plastic zip pouch. UPC: 0-41172-00046-7, Manufactured By: Water Gardens Confections, LLC, Orem, Utah, 84057. (87017) | Water Gardens Confections LLC | Food | Class II | 1 |
| 17 Dec 2020 | ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by Ndal Laboratories, 449 Alvarado St., Monterey, CA 93940 (bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8. the Alvarado St. is for the… (87101) | NDAL Mfg Inc. | Drug | Class I | 1 |
| 8 Dec 2020 | Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities. | Canon Medical System, USA, INC. | Device | Class II | 3 |
| 19 Nov 2020 | Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva Pharmaceuticals, Inc., Gerogetown, IN 47122, Made in India, NDC 59923-714-02. (87363) | Areva Pharmaceuticals Inc | Drug | Class II | 1 |
| 7 Jul 2020 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400 | CareFusion 213, LLC | Drug | Class I | 4 |
| 23 Feb 2012 | Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders,… | Tosoh Bioscience Inc | Device | Class II | 1 |