| 20 Sep 2020 | Trader Joe's Southwest Style Sweet Potato Sauté Bowl NET WT. 21.05oz (1 LB 5.5 OZ) 610g UPC 00661126 packaged in a clear plastic bowl with lid | Renaissance Food Group LLC | Food | Class I | 1 |
| 16 Sep 2020 | Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distributed by: Perrigo, Allegan, MI 49010 NDC 45802-088-01 | Perrigo Company PLC | Drug | Class II | 1 |
| 9 Sep 2020 | Lightly salted microwave popcorn packaged in the following ways: 1) Cadia Organic Lightly Salted Popcorn, Net Wt. 9.9 oz (281 g) 3-3.3 oz (94 g) bags, KeHDistributors LLC, Naperville, IL, UPC 15369-01288 2) Lidl, Naturally Flavored Butter Microwave Popcorn, 3-3.3 oz (94g) bags, Net Wt 9.9 oz (218 g), Distributed by… | Gilster-Mary Lee Corp. | Food | Class II | 5 |
| 8 Sep 2020 | Pretty Thai brand Sweet Chili Sauce Net Wt 11.2 oz (317g) UPC 860043001224 packaged in a clear PET plastic bottle with a white label. Event 86407 | Ponder Foods | Food | Class II | 1 |
| 5 Sep 2020 | Coolhaus Awesome Ice Cream -That Dough Though Ice Cream Sandwich; Chocolate chip cookies, cookie dough batter with gobs of cookie dough. Keep Frozen Contains: Milk, Wheat, Eggs 5.8 oz . serve package - polypropylene film wrapper. UPC: 8 51916 00349 0 Coolhaus, Culver City, CA. 90232 | COOLHAUS | Food | Class II | 1 |
| 4 Sep 2020 | Goodie Girl, Gluten Free Magical Animal Crackers, 7 ounce , paper cartons, 6 packages per case, Best By JAN 11 21 A3 Event 86413 | Toufayan Bakery, Inc. | Food | Class I | 1 |
| 3 Sep 2020 | Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, McLean, VA 22102, USA, Made in China. Event 86390 | CORGIOMED LLC | Drug | Class I | 1 |
| 3 Sep 2020 | bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos Hidraulicos No. 1 Secc. A, Col La Loma Zona Industrial, Tlalnepantla de Baz C.P. 54060 Edo. Mexico. UPC 7 502272 12108 5 Event 86388 | AJR TRADING LLC | Drug | Class II | 1 |
| 3 Sep 2020 | Herr s GameDay Tailgate Tacos Flavored Potato Chips 6.5 oz. packaged in a flexible metalized bag. UPC Code: 7260006434 | Herr Foods Inc | Food | Class III | 1 |
| 2 Sep 2020 | Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-9283-01 | Preferred Pharmaceuticals, Inc. | Drug | Class II | 4 |
| 1 Sep 2020 | Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling. Event 86377 | The Protein Shoppe | Drug | Class I | 1 |
| 31 Aug 2020 | Ancient Grain Jackfruit Bowl with Chickpeas & Edamame in a Thai Coconut Sauce, Eat Fresco, Keep Refrigerated, NET WT 14oz (397gr), Cook Thoroughly Event 86376 | Fresco Foods | Food | Class II | 1 |
| 28 Aug 2020 | Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382 | Siemens Healthcare Diagnostics Inc | Device | Class II | 1 |
| 28 Aug 2020 | Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 28 Aug 2020 | Organic Yellow Popcorn packaged in the following ways: 1) Great Northern Organic Popcorn, Net Wt. 5 Pounds (2.26 Kilograms), UPC 6 10708 14709 1; 2) Hometown Food Company, Organic Butterfly Popcorn, 2200 LBS, Preferred Popcorn LLC Chapman, NE; 3) Lesser Evil, Organic Yellow Butterfly Popcorn, 2185 LBS Preferred… Event 86353 | Name withheld | Food | Class II | 1 |
| 28 Aug 2020 | Arrowhead Mills Organic Yellow Popcorn, 28oz bag, UPC: 0 7433347665 8, 6 retail bags per wholesale case, case item code 1 7433347665 9 | Hometown Food Company | Food | Class II | 1 |
| 27 Aug 2020 | Blanxart 82% Congo Organic Chocolate Bar. Paper packaging with internal foil wrapper. Net weight per bar: 4.4 oz. UPC 8 32924 00032 9. The product label is read in parts: "***BLANXART *** ORGANIC DARK CHOCOLATE 82% CONGO ***Ingredients: cocoa, cocoa butter, sugar, vanilla ***Imported By: Culinary Collective,… | Power Selles Imports dba Culinary Collective | Food | Class II | 1 |
| 27 Aug 2020 | Signature Select Chewy Granola Bars, Chocolate Chip, Family Pack, 18 bars, UPC 021130-283637. 18-0.84 oz. Net Wt 15.2 oz (432g) Distributed By Better Living Brands LLC PO Box 99, Pleasanton, CA 94566-0009, | Treehouse Foods | Food | Class I | 1 |
| 27 Aug 2020 | MBF-202 Carrageenan Event 86362 | Ingredients Solutions Inc. | Food | Class II | 1 |
| 26 Aug 2020 | BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570. | Beckman Coulter Inc. | Device | Class II | 1 |
| 26 Aug 2020 | EVOLVE STEM 8.5MM Model # 496S085 | Wright Medical Technology Inc | Device | Class II | 1 |
| 26 Aug 2020 | Back to Nature, Organic Rosemary and Olive Oil Stoneground Wheat Cracker, 6 oz. foil bag inside paper carton, 6 packages per case . | B&G Foods North America, Inc | Food | Class II | 1 |
| 25 Aug 2020 | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures. | Terumo Cardiovascular Systems Corporation | Device | Class II | 3 |
| 25 Aug 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg], 1 Grain (65 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3300-4; b) 60-count bottles, NDC 64727-3300-5; c) 90-count bottles, NDC 64727-3300-6; d) 100-count bottles, NDC 64727-3300-1; and e) 1,000-count bottles, NDC… | RLC Labs Inc. | Drug | Class I | 24 |
| 25 Aug 2020 | Newman's Own Organics, Newman's Special Decaf Medium Roast, Ground Coffee, 10 oz. Event 86314 | Name withheld | Food | Class II | 1 |
| 25 Aug 2020 | Taylor Farms BBQ Ranch Chopped Kit Salade Coupee Chili Lime Tortilla Squares, Bacon & BBQ Ranch Dressing NET WT 277 g (13.3 oz) UPC 30223 04171 | Taylor Farms Retail Inc | Food | Class II | 1 |
| 24 Aug 2020 | Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right… | Irvine Biomedical Inc, a St. Jude Medical Co. | Device | Class II | 2 |
| 24 Aug 2020 | Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180) | Imactis | Device | Class II | 1 |
| 24 Aug 2020 | EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 24 Aug 2020 | Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. | Teva Pharmaceuticals USA | Drug | Class II | 3 |
| 24 Aug 2020 | Lay's Barbecue Flavored Potato Chips 1 oz. UPC 28400 00861; Lay's Barbecue Flavored Potato Chips 1 1/2 oz. UPC 28400 00300; Lay's Barbecue Flavored Potato Chips 2 5/8 oz. UPC 28400 32420; Lay's Barbecue Flavored Potato Chips 7 3/4 oz. UPC 28400 19961; Lay's Barbecue Flavored Potato Chips 12 1/2 oz. UPC 28400 31040;… | Frito-Lay, Inc. | Food | Class I | 7 |
| 22 Aug 2020 | Peach Salsa, Keep Refrigerated packed in the following size containers and brands: 1. Crazy Fresh, Net Wt. 8 oz UPC 795631 820270; 2. quick & easy, Net Wt 8 oz UPC 795631 820270; 3. Not branded, clear sticker Net Wt 8 oz UPC 795631 820270; 4. Not branded, Net Wt. 3 lbs. UPC 795631 820355. | Russ Davis Wholesale, LLC | Food | Class I | 1 |
| 21 Aug 2020 | Cedar's Cucumber Garlic Dill Tzatziki, 12 oz packaged in clear plastic tubs; Made with GREEK YOGURT; INGREDIENTS: CULTURED PASTEURIZED NONFAT MILK, CULTURED PASTEURIZED CREAM, MILK PROTEIN CONCENTRATE, STABILIZER (TAPIOCA STARCH, AGAR-AGAR, PECTIN), CUCUMBER, GARLIC, SEA SALT, ORGANIC DISTILLED WHITE VINEGAR, DILL | Cedar's Mediterranean Foods, Inc. | Food | Class II | 1 |
| 21 Aug 2020 | Ruffles Original Potato Chips NET WT 1 1/2 oz. packaged in flexible bags UPC 28400 48228 | Frito-Lay, Inc. | Food | Class I | 1 |
| 21 Aug 2020 | Wegmans Vanilla Trifle; 9oz; UPC 7789080600 | Wegmans Food Markets, Inc. | Food | Class I | 11 |
| 21 Aug 2020 | SCHAWS SWEET AND SASSY GOURMET BARBECUE AND BASTING SAUCE, 18oz glass jar, UPC code 6 90379 81241 | Lac O' Seasons Resort,Inc | Food | Class II | 2 |
| 20 Aug 2020 | Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190 | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 20 Aug 2020 | Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A) | Brainlab AG | Device | Class II | 1 |
| 20 Aug 2020 | RONZONI SINCE 1915 Smart Taste Extra Wide Noodle Style 2.5x the Fiber of Regular Pasta Net Wt. 12OZ (340g). UPC: 7130005008 Event 86326 | Riviana Foods Inc | Food | Class I | 1 |
| 20 Aug 2020 | SOUTHERN GROVE; MIXED NUTS; LESS THAN 50% PEANUTS; PEANUTS, ALMONDS, CASHEWS, HAZELNUTS, & PECANS; with Sea Salt; NET WT 14.75 OZ (418g); INGREDIENTS: PEANUTS, ALMONDS, CASHEWS, HAZELNUTS(FILBERTS), PECANS, PEANUT AND/OR COTTONSEED OIL, SEA SALT; CONTAINS: PEANUTS, TREE NUTS (ALMONDS, CASHEWS, HAZELNUTS(FILBERSTS),… Event 86281 | The Superior Nut Company, Inc. | Food | Class II | 1 |
| 19 Aug 2020 | Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 19 Aug 2020 | Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10 | BAYSHORE PHARMACEUTICALS | Drug | Class II | 2 |
| 19 Aug 2020 | Fresh peaches - sold loose/bulk and Bagged fresh peaches, 2 lbs. plastic pouch under brand names of: Wawona- UPC 033383322001 Wawona Organic- UPC 849315000400 Prima - UPC 766342325903, Walmart Organic Marketside - UPC 766342325903, Kroger - UPC 011110181749, Wegmans - UPC 077890490488 5-11 pieces per bag, 10-15 bags… Event 86284 | Wawona Packing Co LLC dba Prima Wawona | Food | Class I | 1 |
| 18 Aug 2020 | Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico… | Nanomateriales Sa De Cv | Drug | Class II | 2 |
| 18 Aug 2020 | Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 714 Col. Contry La Silla, Monterrey, Nuevo Leon, Mexico Tel. +52 812473-8453, NDC # 76592-002-04, UPC 6 03765 37699 3 | GRUPO YACANA MEXICO SAS DE CV | Drug | Class II | 2 |
| 18 Aug 2020 | Whole Foods Market Vegan Vanilla Cake 6 Inch NET WT 2lb 11oz (1219g) Packed for Whole Foods Market PLU 41070 packaged in plastic dome containers with Whole Foods Market scale labels | Whole Foods Market | Food | Class I | 1 |
| 17 Aug 2020 | Speed Stitch Needle Cassette | ArthroCare Corporation | Device | Class II | 1 |
| 17 Aug 2020 | Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net Event 86268 | Maison Terre, LLC | Drug | Class I | 1 |
| 17 Aug 2020 | Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103. | Mylan Institutional LLC | Drug | Class I | 2 |
| 17 Aug 2020 | A.S.K. Foods, Inc. Lobster Salad (2.5 lb.) with codes of 4472 or 4482 , Bulk Containers / 2 Containers per Case ( Product ), SELL BY: 08-28-20 | ASK Foods Inc | Food | Class I | 1 |
| 14 Aug 2020 | Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 14 Aug 2020 | NM/CT 850 Model Number: H3907AD | GE Healthcare, LLC | Device | Class II | 8 |
| 14 Aug 2020 | Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica, Portugal S.A., Distributed by: Hikma Pharmaceuticals, Eatontown, NJ 07724, USA Inc., NDC: 0143-9246-01. | Hikma Pharmaceuticals USA Inc. | Drug | Class II | 1 |
| 14 Aug 2020 | SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147103 | SG24 LLC | Drug | Class I | 4 |
| 12 Aug 2020 | Central Line Dressing Change Tray | Medline Industries Inc | Device | Class II | 1 |
| 11 Aug 2020 | Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70… | Cook Inc. | Device | Class II | 1 |
| 11 Aug 2020 | Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola. | Randox Laboratories Ltd. | Device | Class II | 2 |
| 11 Aug 2020 | ORGANIC VALLEY EGG BITES feta & chives NET WT 4 OZ (114g) UPC# 0 93966 81195 7 Distributed by Organic Valley, La Farge, WI 54639 Event 86220 | Almark Foods | Food | Class II | 1 |
| 11 Aug 2020 | SERAFIN FISHERY Salmon Fish Dip, 8 oz | Name withheld | Food | Class I | 2 |
| 10 Aug 2020 | The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm. | Exactech, Inc. | Device | Class II | 1 |
| 10 Aug 2020 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05. | Aurobindo Pharma USA Inc. | Drug | Class II | 1 |
| 10 Aug 2020 | BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 | Par Pharmaceutical Inc. | Drug | Class II | 1 |
| 10 Aug 2020 | Red Onions, Bulk | Lancaster Foods LLC | Food | Class I | 1 |
| 10 Aug 2020 | Red Onions; Pacific Gold 25 Lb. RED Onion JBO - Pacific Gold w/plu 50 lb. SX Red Onion JBO US #1 Sold to consumers in bulk pins. in bulk bins | Progressive Produce LLC | Food | Class I | 2 |
| 10 Aug 2020 | Saddlin' Up Salsa Hot, item number 83260, refrigerated product, ready to eat product, packaged in a 15 oz. plastic tub with a plastic lid. UPC 88694 83257. | Spokane Produce, Inc. | Food | Class I | 4 |
| 10 Aug 2020 | Whole Foods Market El Trigal 12 Month Old Manchego PLU 29329500000; Whole Foods Market El Trigal 6 Month Old Manchego PLU 29329900000; Whole Foods Market Mitica Cordobes PLU 29335700000; Individual sliced cheese wrapped in plastic wrap with scale label on top. | Whole Foods Market | Food | Class I | 9 |
| 8 Aug 2020 | Fantis Pita 10 x 7" Pita Bread, 25 oz. 12 per case. Frozen Case lists Fantis Foods 7" Gryo, UPC 00076598772001 Case label properly lists Contains: Wheat, Milk 25 oz. Packages UPC 0 76665 00037 Ingredients: Enriched Wheat Flour (contains Flour, niacin, thiamin Mononitrate, Riboflavin, Folic Acid) Water, Soybean oil,… Event 86237 | Fantis Foods California, Inc. | Food | Class II | 1 |
| 7 Aug 2020 | FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling… | Name withheld | Device | Class II | 3 |
| 7 Aug 2020 | Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292 | Maquet Cardiovascular Us Sales, Llc | Device | Class III | 1 |
| 7 Aug 2020 | Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay | Tosoh Bioscience Inc | Device | Class II | 2 |
| 7 Aug 2020 | Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment to a Chest Drainage device. The thoracic catheter is indicated for use less than 30 days. | TELEFLEX MEDICAL INC | Device | Class II | 1 |
| 7 Aug 2020 | WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. | Boston Scientific Corporation | Device | Class II | 1 |
| 7 Aug 2020 | UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid Oz./89 mL bottes, Manufactured By Santa Cruz Biotechnology, Inc. 10410 Finnell St. Dallas, TX 75220 Event 86197 | Santa Cruz Biotechnology, Inc | Drug | Class II | 1 |
| 7 Aug 2020 | Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in a) Single snaps (NDC 75091-2020-1 UPC 375091202016); b) 100-count boxes (NDC 75091-2020-2 UPC 375091202023); c) 25-count boxes (NDC 75091-2020-3 UPC 375091202030) | Name withheld | Drug | Class II | 2 |
| 7 Aug 2020 | Lemons, 2lb mesh bag sold under the brand names of Fresh from the Start, UPC 33383 14020 & Wegmans, UPC 77890 15917 | Freshouse Produce | Food | Class II | 4 |
| 7 Aug 2020 | Wegmans Chicken Cutlet; by the lb, in a meal or in a 22 oz. Family Pack; "Heating Instructions: Oven-Preheat to 400 degrees F. Remove chicken from package and place on baking sheet pan. Bake 5-7 minutes. Microwave-Remove label/lid. Heat 2-3 minutes"; Keep Refrigerated; packaged in plastic clamshell | Wegmans Food Markets, Inc. | Food | Class II | 23 |
| 6 Aug 2020 | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from… | Life Technologies Corporation | Device | Class II | 2 |
| 6 Aug 2020 | Merge PACS | Merge Healthcare, Inc. | Device | Class II | 1 |
| 6 Aug 2020 | Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for… Event 86227 | Talladium Inc | Device | Class II | 1 |
| 6 Aug 2020 | Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9% bacteria and germs, a) 4.2 Oz./125 mL bottle, NDC: 71761-000-00, UPC: 7502278002555, Distributed by Pacific Coast Global Inc. Chula Vista, CA 91911, Made in Mexico b) 33.8 Oz./1 L, UPC: 7502278002586, Made in Mexico By Incredible… Event 86199 | Incredible Products, SA de CV | Drug | Class I | 1 |
| 6 Aug 2020 | Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India | Hetero Labs Limited (Unit V) | Drug | Class II | 1 |
| 6 Aug 2020 | Whole Foods Market Buttermilk Biscuits, 4pk NET WT 1lb 0 oz PLU: 30561 packaged in plastic clam shell | Whole Foods Market | Food | Class II | 1 |
| 5 Aug 2020 | Charlies Produce Anchorage, WHITE Peeled Onions, Jumbo, Ready To Eat (RTE), keep refrigerated. Shelf-life: packing date plus 6 days. Packed in corrugated cardboard box. Net. wt. 20 lbs., no UPC. Product was peeled and packaged by Charlie s Produce 9401 King St., Anchorage, AK 99515. | Triple B Corporation | Food | Class I | 3 |
| 4 Aug 2020 | Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 | Hologic, Inc | Device | Class II | 1 |
| 4 Aug 2020 | BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and… | CareFusion 303, Inc. | Device | Class II | 1 |
| 4 Aug 2020 | 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical… | Integra LifeSciences Corp. | Device | Class II | 3 |
| 4 Aug 2020 | BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652 | CareFusion 303, Inc. | Device | Class I | 1 |
| 4 Aug 2020 | Alaris System PC Unit Model 8015 | CareFusion 303, Inc. | Device | Class I | 2 |
| 4 Aug 2020 | BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump. | CareFusion 303, Inc. | Device | Class I | 1 |
| 4 Aug 2020 | Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250mL bottle, Roqueplast S.A. de C.V. Cda. Adolfo Manfredi #7 Altizapan de Zaragoza CP 52958 Edo de Mexico UPC 8 52239 00689 2 Event 86172 | ROQUE PLAST, S.A. DE C.V. | Drug | Class II | 1 |
| 4 Aug 2020 | Taylor Farms Foodservice Onion Yellow Dice 1/8" Pack Size 4/5#; Taylor Farms Foodservice Onion Yellow Dice 1/4" Pack Size 4/5#; Taylor Farms Foodservice Onion Yellow Slice 1/4" Pack Size 4/5#; Taylor Farms Foodservice Onion Yellow Dice 1/4" Pack Size 2/5#; Taylor Farms Foodservice Onion Yellow Dice 3/8" Pack Size… | Taylor Farms Texas, Inc. | Food | Class I | 11 |
| 3 Aug 2020 | Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%, packaged as a) 16 fluid oz./473.18 mL, bottle. b) 5 gallon vacuum sealed bucket. Leiper's Fork Distillery Event 86182 | Leiper's Fork Distillery | Drug | Class II | 1 |
| 2 Aug 2020 | The following products received from the UNFI Distribution Center Champaign, IL on 7/12/2020: Ditch Farms Eggs brand: Grade A Large (20/18ct; UPC 2009194510035) and (30/12ct; UPC 1004127044750) and (30/6ct; UPC 1009194510032) ; Grade A Large Brown (30/12ct; UPC 2009194510060); Grade A Medium (20/1.5dz; UPC… | UNFI General Corporate | Food | Class II | 1 |
| 2 Aug 2020 | Sub Shop-Red Onions. Expiration 7/31/2020. Ingredients raw red onion. | Name withheld | Food | Class I | 54 |
| 1 Aug 2020 | Spicy Beef & Vegetables with Rice & Sesame Seeds meal kits containing onions delivered the week of July 27, 2020. | Blue Apron Inc | Food | Class II | 3 |
| 1 Aug 2020 | Red onions; Packed under brand names of Thomson Premium, Onions 52, Utah Onions, Harley's Best, Onions 52, Imperial Fresh, TLC Thomson International, El Competidor Thomson Premium packed in 50 and 25 lb.mesh sack, and 2 lb. mesh sack - UPC 33383 60101 3 lb. mesh sack - UPC 33383 60102 TLC International - 40 lbs.… | Thomson International, Inc. | Food | Class I | 4 |
| 1 Aug 2020 | Various HelloFresh and EveryPlate meal kits containing onions received by consumers from June 25 through July 31, 2020. Event 86265 | Name withheld | Food | Class I | 1 |
| 31 Jul 2020 | PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component. | MicroPort Orthopedics Inc. | Device | Class I | 2 |
| 31 Jul 2020 | Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting. Event 86146 | Klarity Medical Products LLC | Device | Class II | 1 |
| 31 Jul 2020 | PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK A/R VAR/VAL 2… | MicroPort Orthopedics Inc. | Device | Class II | 1 |
| 31 Jul 2020 | Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8 Event 86154 | The Mentholatum Company | Drug | Class III | 1 |
| 31 Jul 2020 | Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380, Guadalajara, Jalisco, Mexico, Made in… Event 86167 | Laboratorios Jaloma S.A. de C.V. | Drug | Class II | 1 |
| 31 Jul 2020 | M60026CS Onions Yellow Sliced sold by pound for foodservice use. Product is perishable, refrigerated, shelf life 5 days, and packed in 5 lbs. cello bags. No label was attached/provided. | Emerald Fruit & Produce Inc | Food | Class I | 12 |
| 30 Jul 2020 | Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder | Cook Inc. | Device | Class II | 1 |
| 30 Jul 2020 | AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma | RANDOX LABORATORIES, LTD. | Device | Class II | 2 |
| 30 Jul 2020 | Cios Alpha, Image-Intensified Fluoroscopic X-Ray System 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 | 2 |
| 30 Jul 2020 | Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab Place St. Paul, MN 55102 USA, NDC 47593-624-21 | Ecolab Inc | Drug | Class II | 1 |
| 29 Jul 2020 | PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need. | Cardinal Health 200, LLC | Device | Class II | 8 |
| 29 Jul 2020 | RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 29 Jul 2020 | AVANOS MIC-KEY SF Gastrostomy Feeding Tube | Avanos Medical, Inc. | Device | Class II | 1 |
| 29 Jul 2020 | Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. | Sorin Group Italia S.r.l. | Device | Class II | 5 |
| 29 Jul 2020 | Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544. | SCA Pharmaceuticals | Drug | Class I | 4 |
| 29 Jul 2020 | Material Number 7002 Unique Tracking Number 1000035843 3/8" Diced Green Chilies (440 lb drum) Event 86144 | SUN VALLEY FOODS LLC | Food | Class II | 1 |
| 28 Jul 2020 | BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack | Becton Dickinson & Company | Device | Class II | 1 |
| 28 Jul 2020 | Cooked, Peeled and Deveined, Tail-on, Shrimp. AQUA STAR RESERVE-(1) 26/30 shrimp per pound, NET WT 1lbs UPC:3114960591 and (2) 31/40 shrimp per pound, NET WT 1lbs UPC:3114965212. CENSEA- (1) 31/40 shrimp per pound, NET WT 32Oz, 2lbs, 908g UPC:7004160011,(2) 41/50 shrimp per pound, NET WT 32Oz, 2lbs, 908g… Event 86235 | Kader Exports Pvt. Ltd. | Food | Class II | 1 |
| 27 Jul 2020 | Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports. Event 86128 | Name withheld | Device | Class II | 1 |
| 27 Jul 2020 | Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube. | Name withheld | Device | Class II | 8 |
| 27 Jul 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. | Datascope Corporation | Device | Class II | 17 |
| 27 Jul 2020 | Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024 | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 27 Jul 2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl. oz. (125ml) bottle, UPC 7 14706 91368 6; b) 8.4 fl. oz. (250 ml) bottle, UPC 714706 91367 9; c) 16.9 fl. oz. (500 ml) bottle, UPC 7 14706 91366 2; and d) 33.8 fl. oz. (1 Liter) bottle, UPC 7 14706 91365 5; Made in Mexico by:… | Broncolin, S.A. de C.V. | Drug | Class I | 2 |
| 27 Jul 2020 | Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL) bottles, Distributed by: Access USA, Miami, FL 33308, UPC 650240025020 | RESOURCE RECOVERY & TRADING LLC | Drug | Class II | 2 |
| 24 Jul 2020 | Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 24 Jul 2020 | Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 23 Jul 2020 | Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic… | Remel Europe Ltd. | Device | Class II | 1 |
| 23 Jul 2020 | scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC New York, NY 10018, Made in Mexico, UPC 8 40038 21434 1 | Real Clean Distribuciones SA de CV | Drug | Class I | 5 |
| 22 Jul 2020 | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile) | Globus Medical, Inc. | Device | Class II | 22 |
| 22 Jul 2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05 | Fresenius Kabi USA, LLC | Drug | Class I | 1 |
| 21 Jul 2020 | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during… | Neurovision Medical Products Inc | Device | Class II | 9 |
| 21 Jul 2020 | O Organics Tahini is 100% organic ground slightly roasted sesame seed paste, packaged in 16oz glass jar with metal screw on/off lid and has a paper anti tampering seal connecting the lid with the jar. UPC 0 79893 39024 6. The label is read in parts: "***O Organic TAHINI *** INGREDIENTS: ORGANIC SESAME SEEDS ***… Event 86097 | ACME FOOD SALES INC | Food | Class II | 1 |
| 20 Jul 2020 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) | Conformis, Inc. | Device | Class II | 1 |
| 20 Jul 2020 | VITROS XT3400 Chemistry System, Product code 6844458 | Ortho Clinical Diagnostics | Device | Class II | 2 |
| 17 Jul 2020 | Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans. Event 86113 | Name withheld | Device | Class II | 1 |
| 17 Jul 2020 | Parvovirus B19 IgG EIA kit Part No. V519IGUS | Diasorin Inc. | Device | Class II | 1 |
| 16 Jul 2020 | Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of… | Name withheld | Device | Class III | 2 |
| 16 Jul 2020 | HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biologicals, Inc. 469 W. Parkland Drive, Sandy, UT 84070, NDC: 43742-1299-1 | Grato Holdings, Inc. | Drug | Class II | 1 |
| 15 Jul 2020 | SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard structures in the mouth, such as teeth or bone, it is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices. Event 86147 | Hager & Meisinger Gmbh | Device | Class II | 1 |
| 15 Jul 2020 | SICAT IMPLANT V2.0 Event 86165 | SICAT GMBH & CO. KG | Device | Class II | 1 |
| 15 Jul 2020 | The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device. | Medtronic Inc. | Device | Class II | 1 |
| 15 Jul 2020 | CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts. | OraSure Technologies, Inc. | Device | Class III | 3 |
| 15 Jul 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy… | Stimwave Technologies Inc | Device | Class II | 6 |
| 15 Jul 2020 | QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport… | Qiagen Sciences LLC | Device | Class II | 1 |
| 14 Jul 2020 | CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume. | GE Healthcare, LLC | Device | Class II | 1 |
| 14 Jul 2020 | Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 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 | 1 |
| 14 Jul 2020 | Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7 Event 86042 | Soluciones Cosmeticas, SA de CV | Drug | Class II | 1 |
| 13 Jul 2020 | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB | OraSure Technologies, Inc. | Device | Class III | 2 |
| 13 Jul 2020 | VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931 | Ortho-Clinical Diagnostics | Device | Class II | 3 |
| 10 Jul 2020 | Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent | RANDOX LABORATORIES, LTD. | Device | Class II | 2 |
| 9 Jul 2020 | Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01 Event 86063 | Maquiladora Miniara Sa De Cv | Drug | Class II | 1 |
| 8 Jul 2020 | System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147 | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 2 Jul 2020 | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5 | AAA Cosmetica, SA de CV | Drug | Class I | 2 |
| 2 Jul 2020 | Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01 | Edge Pharma, LLC | Drug | Class II | 1 |
| 30 Jun 2020 | SUNDIAL (4 oz.) ETHIOPIAN TENADAM HERB; "***Strengthens the Vein & Capillaries***lowers high Blood pressure, regulate Heartbeat.***heals Stomach ulcers***" | Sundial Herbal Products | Food | Class II | 68 |
| 24 Jun 2020 | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits. Event 86279 | DNA Genotek Inc. | Device | Class III | 1 |
| 24 Jun 2020 | Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0 Event 85869 | Name withheld | Drug | Class I | 1 |
| 23 Jun 2020 | Neurosign V4 Intraoperative Nerve monitor family of devices. | The Magstim Company Limited | Device | Class II | 1 |
| 22 Jun 2020 | CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure. The system can… Event 85910 | Biosense Webster (israel), Ltd. | Device | Class II | 1 |
| 17 Jun 2020 | DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis.… | Beckman Coulter Biomedical GmbH | Device | Class II | 1 |
| 10 Jun 2020 | Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845. | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 3 Jun 2020 | PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4, LH-1-5, LH-1-5CC, LH-1-15CC - Product Usage: intended for stabilization, transportation, and inactivation of infectious unprocessed nasal washes, nasopharyngeal, oral/throat swabs* suspected of containing Influenza A virus RNA.… Event 86189 | Name withheld | Device | Class II | 1 |
| 3 Jun 2020 | Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky Mtn. Sunscreen, UPC 7 54018 20004 3 | Yusef Manufacturing Laboratories, LLC | Drug | Class II | 1 |
| 8 May 2020 | The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room… | Ge Healthcare | Device | Class II | 1 |
| 5 May 2020 | Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4 | Exela Pharma Sciences LLC | Drug | Class III | 1 |
| 21 Apr 2020 | BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum… | Bio-Rad Laboratories, Inc. | Device | Class II | 1 |
| 31 Jan 2020 | LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging Event 86158 | 89 NORTH | Device | Class II | 1 |
| 10 Sep 2019 | NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA. | Novarad Corporation | Device | Class II | 1 |
| 21 Feb 2019 | Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971 | ArthroCare Corporation | Device | Class II | 1 |
| 31 Mar 2016 | E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |