| 11 Nov 2020 | Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 11 Nov 2020 | Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 | Apotex Corp. | Drug | Class II | 1 |
| 9 Nov 2020 | 1. Giant brand " Premium Apple Cider*** 64 fl. oz. (Half Gal) 1.89L***Distributed by Foodhold USA LLC, Landover, MD 20785" 2. "Nature's Nectar 100% Fresh Apple Cider***128 fl. oz.***Distributed by Aldi, Inc. Batavia, IL 60510" 3. Open Acres Honeycrisp Apple Cider, 128 fl. oz 4. Mayer Bros. Apple Cider, 128 fl. oz. Event 86732 | Mayer Brothers Apple Products, Inc. | Food | Class II | 1 |
| 6 Nov 2020 | Rosebud's brand Elderberry Syrup Kit in a 3 oz. clear stand-up pouch (GS1 Code 852782007834). Event 86723 | Rosebud's Ranch and Garden, LLC | Food | Class II | 1 |
| 5 Nov 2020 | John Nagle Steelhead Fillets; 1/3 lb; Iceland; N44515; Habrun ehf; Packaging date: 29 10 2020 Event 86722 | John Nagle Co. | Food | Class II | 1 |
| 3 Nov 2020 | Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25. | Hikma Pharmaceuticals USA Inc. | Drug | Class II | 1 |
| 1 Nov 2020 | Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc. | Preferred Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 30 Oct 2020 | Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12 | AVKARE Inc. | Drug | Class II | 1 |
| 28 Oct 2020 | Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 28 Oct 2020 | Frozen French Cut Green Beans. Packaged in 20.5 lb boxes. Expiration date 11/25/2022 Event 86675 | National Food Trading Corporation | Food | Class I | 1 |
| 28 Oct 2020 | Art Of Tea - Feel Better tea; Produced and Distributed by: Art of Tea LLC, Monterey Park, CA Directions: 1 Tbsp of tea in 8 oz. of water at 206 degrees; steep for 5-7 minutes. Packaged in: Black Mylar bag with label, Silver Mylar bag with label, Silver Tin Canisters with Label; 40oz, 1 lb, 5 lb (bags); 3 oz (tins).… Event 86691 | Art Of Tea | Food | Class II | 1 |
| 28 Oct 2020 | J&O Mixed Veggie Cup with Dip, Net Weight 5.0 oz. (128 g), UPC 95631-85818. Mfg By: RDW, Pueblo CO 81001 | Russ Davis Wholesale, LLC | Food | Class I | 1 |
| 27 Oct 2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77 | Zydus Pharmaceuticals (USA) Inc | Drug | Class II | 2 |
| 26 Oct 2020 | Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 26 Oct 2020 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles, Rx Only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722, NDC 31722-943-01 | Ascent Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 26 Oct 2020 | Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32 | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 23 Oct 2020 | Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako… | Mako Surgical Corporation | Device | Class II | 1 |
| 23 Oct 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01 | Nostrum Laboratories Inc | Drug | Class II | 2 |
| 23 Oct 2020 | Trader Joe's brand Gluten Free Battered Halibut, SKU 00503822. Product of USA. Frozen product is packed in plastic bag and sold in retail carton box (10 oz. box). Each master case contains 20/10 oz. boxes. RETAIL BOX'S label is read in parts: '***TRADER JOE'S BATTERED HALIBUT GLUTEN FREE ***INGREDIENTS: HALIBUT,… Event 86654 | Orca Bay Foods LLC | Food | Class I | 1 |
| 23 Oct 2020 | IncredibleStoneCrab, Mustard Sauce, 8 oz. plastic container, Distributed by: IncredibleStoneCrab, Event 86662 | Name withheld | Food | Class I | 1 |
| 22 Oct 2020 | Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications. | Cook Inc. | Device | Class I | 1 |
| 22 Oct 2020 | Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92 | Aurobindo Pharma USA Inc. | Drug | Class III | 1 |
| 22 Oct 2020 | TROPIQUE ASSORTED FRUIT JELLY BAG 30/9PCS/10.06oz and TROPIQUE JELLY ANIMAL JAR 6/26OZ Event 86637 | Name withheld | Food | Class I | 1 |
| 22 Oct 2020 | Aldi Little Salad Bar Classis Coleslaw (Green cabbage and carrots), 14 oz. plastic bag UPC:0-414498-30217-7 Kroger brand Coleslaw (Green cabbage and carrots) 16 oz. plastic bag UPC: 0-11110-91040-0 | Dole Fresh Vegetables Inc | Food | Class III | 1 |
| 21 Oct 2020 | Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including,… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 21 Oct 2020 | Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663 | H & H Remedies, LLC | Drug | Class II | 3 |
| 20 Oct 2020 | Alpen Clinic 100 Carbide Instruments (R100057C) | Coltene Whaledent Inc | Device | Class II | 5 |
| 20 Oct 2020 | FC TOMATOES ROMA DICED 3/8" 1/5#; FC TOMATOES ROMA DICED 3/8" 4/5#, and FC TOMATOES ROMA DICED 3/8" 2/5# all packaged in white plastic trays with heat seal lid, packed inside a cardboard box Event 86683 | Name withheld | Food | Class II | 1 |
| 19 Oct 2020 | Denali Ingredients Cream Tech 250 Sour Cream Stabilizer, Item 500120-1014, 50 lb. bag. Storage: For maximum Freshness Store at Ambient Temperatures Below 85F. This container is intended for Food Products Only. No other Use Authorized. Dispose of in an Approved Manner. | Denali Ingredients LLC | Food | Class III | 2 |
| 16 Oct 2020 | VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474 | Ortho Clinical Diagnostics Inc | Device | Class III | 1 |
| 16 Oct 2020 | Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001 | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 16 Oct 2020 | Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC 980X3PLDIPC 980X3ESDIEC 980X3ITDIEC 980X3JADIJJ… | Covidien Llc | Device | Class II | 1 |
| 16 Oct 2020 | Elderberry Whole Organic; Sambucus Nigra; Origin: Croatia 1 lb. and 4 oz. Distributed in Mylar bags. 1 lb. UPC: 7 67963 07315 0; Item # 209290-01 4 oz. UPC 7 67963-10561-5; Item # 209290-04 Daily serving size; Pour 8-12 oz. of boiling water (212 degrees F) over 1 tsp of tea. Steep 3-4 minutes. Starwest… | Starwest Botanicals, Inc | Food | Class I | 2 |
| 14 Oct 2020 | Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355 | Angiodynamics, Inc. | Device | Class II | 1 |
| 14 Oct 2020 | Eishindo brand "CUP JELLY (MINI); NET WT. 28.2oz (800g); 50pcs; INGREDIENTS: WATER, HIGH FRUCTOSE SYRUP, APPLE JUIC, CARAGEENAN, CITRIC ACID, ARTIFICIAL FLAVOR, FD&C YELLOW NO. 5 TARTRAZINE, FD&C YELLOW NO. 6 SUNSET YELLOW FCF, FD&C BLUE NO.1 BRILLIANT BLUE FCF AND FD&C RED NO. 40; IMPORTED BY: HADSON TOKO TRADING… Event 86603 | Hadson (Toko) Trading Co., Inc. | Food | Class I | 1 |
| 12 Oct 2020 | Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90 | Direct Rx | Drug | Class II | 1 |
| 12 Oct 2020 | Happy Tot Superfoods Gluten Free Oat Bar Organic Blueberries & Oatmeal. SKU: TB-BLOT-5 and TB-BLOT-5-WM. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.88 oz (25g) and packed in a 5 pack box (net wt. 4.4 OZ (125g). UPC code: 819573015072. | Name withheld | Food | Class II | 3 |
| 11 Oct 2020 | Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00 | RemedyRepack Inc. | Drug | Class II | 1 |
| 9 Oct 2020 | cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001 | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 9 Oct 2020 | Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation Event 86598 | Primus Corporation | Device | Class II | 1 |
| 9 Oct 2020 | N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023 Event 86617 | Jarrow Formulas Inc | Drug | Class II | 1 |
| 9 Oct 2020 | DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627 | Milbar Laboratories, Inc. | Drug | Class II | 14 |
| 9 Oct 2020 | Rice Pudding 5lb plastic containers. UPC: 4428421260. Refrigerated 34°F-38°F Event 86611 | Spring Glen Fresh Foods | Food | Class I | 1 |
| 9 Oct 2020 | Back to Nature Organic Rosemary & Olive Oil Stoneground Wheat Crackers, NET WT 6 oz (170g)., UPC: 8-19898-01015-8 | B&G Foods North America, Inc | Food | Class I | 1 |
| 8 Oct 2020 | Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate. | Microbiologics Inc | Device | Class II | 1 |
| 8 Oct 2020 | Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and… | Microbiologics Inc | Device | Class II | 3 |
| 8 Oct 2020 | MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200 | Medicrea International | Device | Class II | 1 |
| 8 Oct 2020 | Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30 | Denton Pharma, Inc. | Drug | Class II | 2 |
| 7 Oct 2020 | Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN | Steris Corporation | Device | Class III | 1 |
| 7 Oct 2020 | Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10 | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 6 Oct 2020 | Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium | Exactech, Inc. | Device | Class II | 2 |
| 6 Oct 2020 | Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 | Hardy Diagnostics | Device | Class III | 1 |
| 6 Oct 2020 | metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 2 |
| 6 Oct 2020 | Hu Almond Hunks, Almonds + Sea Salt Chocolate Covered Hunks 4 oz., stand up pouch, 6 bags per case . | Name withheld | Food | Class II | 2 |
| 5 Oct 2020 | Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract. Event 86608 | Micro-Tech Usa | Device | Class II | 1 |
| 5 Oct 2020 | Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01 | Boehringer Ingelheim Pharmaceuticals, Inc. | Drug | Class II | 3 |
| 5 Oct 2020 | FRESH FROM MEIJER CANTALOUPE CHUNKS LARGE BOWL, 32oz Clear plastic container, UPC 219323109721. FRESH FROM MEIJER CANTALOUPE CHUNKS SMALL BOWL, 16oz Clear plastic container, UPC 220196109725. FRESH FROM MEIJER CANTALOUPE CHUNKS KOSHER - LG, 32oz Clear plastic container, UPC 220616800089 FRESH FROM MEIJER CANTALOUPE… | Meijer Inc./Traffic Dept. | Food | Class I | 12 |
| 2 Oct 2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA,… | Marksans Pharma Limited | Drug | Class II | 2 |
| 2 Oct 2020 | Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0 Event 86540 | Name withheld | Drug | Class II | 1 |
| 2 Oct 2020 | Primary/Retail Package labeled in part: "Hu; CHOCOLATE-COVERED HUNKS CASHEWS + VANILLA BEAN; VEGAN; ORGANIC; PALEO; Net Wt. 4 oz (113g); Ingredients: organic cashews, organic cacao, organic unrefined coconut sugar, organic fair-trade cocoa butter, sea salt, organic vanilla bean; Allergy Statement: Contains cashew &… | HU PRODUCTS | Food | Class II | 1 |
| 1 Oct 2020 | The Quidel Triage BNP Calibrators | Medline Industries Inc | Device | Class II | 1 |
| 1 Oct 2020 | EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential… Event 86516 | Epitope Diagnostics, Inc. | Device | Class II | 1 |
| 30 Sep 2020 | COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is… | Merz North America, Inc. | Device | Class II | 1 |
| 30 Sep 2020 | VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique… | Ortho Clinical Diagnostics Inc | Device | Class II | 2 |
| 30 Sep 2020 | Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2),… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 30 Sep 2020 | XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4,… | XTANT Medical | Device | Class III | 1 |
| 29 Sep 2020 | v|tome|x L Series non-destructive testing cabinet x-ray systems Event 86620 | Ge Inspection Technologies Llc | Device | Class II | 1 |
| 28 Sep 2020 | VNS Therapy AspireSR Generator | LivaNova USA Inc | Device | Class II | 1 |
| 28 Sep 2020 | Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310 | Teligent Pharma, Inc. | Drug | Class III | 1 |
| 25 Sep 2020 | QUIDEL Sofia SARS Antigen FIA IVD REF 20374 | Quidel Corporation | Device | Class II | 1 |
| 25 Sep 2020 | Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code: 8881250248 | Cardinal Health 200, LLC | Device | Class II | 1 |
| 25 Sep 2020 | Osteosynthesis Compression Staple EasyClip | Stryker GmbH | Device | Class II | 1 |
| 25 Sep 2020 | Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only. | Exactech, Inc. | Device | Class II | 2 |
| 24 Sep 2020 | Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN Product Usage: intended to be used during the preparation and… | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | Device | Class II | 2 |
| 24 Sep 2020 | Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation device. | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | Device | Class II | 1 |
| 24 Sep 2020 | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item Number: 00-8065-540-22 Hip prosthesis component | Zimmer Biomet, Inc. | Device | Class II | 75 |
| 24 Sep 2020 | AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis | Boston Scientific Corporation | Device | Class II | 1 |
| 24 Sep 2020 | Field Run Peaches: Bulk in bins field run fruit from ranch 82A from 9/4 - 9/23 Event 86513 | Wawona Packing Co LLC dba Prima Wawona | Food | Class I | 1 |
| 24 Sep 2020 | Gracie's Pointe frozen raw shrimp. 1. 8/12 Count Per Pound Tail On, UPC: 849558095034 2. 21/25 Count Per Pound Tail Off, UPC: 849558095065 3. 31/40 Count Per Pound Tail Off, UPC: 849558095072 4. 16/20 Count Per Pound EZ Peel UPC: 849558095003 5. 16/20 Count Per Pound Tail On, UPC: 849558095041 6. 26/30 Count Per… Event 86500 | Capital Seaboard | Food | Class II | 1 |
| 22 Sep 2020 | Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application | Boston Scientific Corporation | Device | Class II | 1 |
| 22 Sep 2020 | Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. | Boston Scientific Corporation | Device | Class II | 1 |
| 22 Sep 2020 | Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product. | Cardinal Health 200, LLC | Device | Class II | 2 |
| 22 Sep 2020 | 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), | Pentax of America Inc | Device | Class II | 2 |
| 22 Sep 2020 | TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic / laparoscopic surgery. The trocar may be… Event 86483 | Gordian Surgical | Device | Class II | 1 |
| 21 Sep 2020 | 5.5MM Arthrogarde Hip Access Cannula | Smith & Nephew, Inc. | Device | Class II | 1 |
| 21 Sep 2020 | DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s… | Synthes (USA) Products LLC | Device | Class III | 15 |
| 21 Sep 2020 | Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 21 Sep 2020 | Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. | GE Healthcare, LLC | Device | Class II | 1 |
| 21 Sep 2020 | Niobe ES System, Models 001-006000-1 and 001-006100-1 Event 86555 | Stereotaxis Inc | Device | Class II | 1 |
| 18 Sep 2020 | ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems 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 |
| 18 Sep 2020 | OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails | Merete Medical GmbH | Device | Class II | 4 |
| 17 Sep 2020 | LOM Disposable Surgical Gowns/Medical Gowns, Single-Use Event 86431 | THREAD COUNSEL INC DBA LAWS OF MOTION | Device | Class II | 1 |
| 17 Sep 2020 | A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended | Genicon, Inc. | Device | Class II | 1 |
| 17 Sep 2020 | Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the… | GE Healthcare, LLC | Device | Class II | 7 |
| 17 Sep 2020 | Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1. | Grato Holdings, Inc. | Drug | Class III | 1 |
| 16 Sep 2020 | Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct… | Boston Scientific Corporation | Device | Class II | 1 |
| 16 Sep 2020 | MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106 | Merit Medical Systems, Inc. | Device | Class II | 3 |
| 15 Sep 2020 | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total). | 3M Company - Health Care Business | Device | Class II | 5 |
| 14 Sep 2020 | Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop… | Philips North America, LLC | Device | Class II | 2 |
| 14 Sep 2020 | Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153118 | Becton Dickinson & Company | Device | Class II | 2 |
| 12 Sep 2020 | Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343 | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 11 Sep 2020 | Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | Device | Class II | 1 |
| 10 Sep 2020 | Instructions For Use document of the GPS Trackers. Event 86491 | Name withheld | Device | Class II | 1 |
| 9 Sep 2020 | GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System | W L Gore & Associates, Inc. | Device | Class II | 1 |
| 9 Sep 2020 | GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System | W L Gore & Associates, Inc. | Device | Class II | 1 |
| 9 Sep 2020 | Lidl Organic Butter Microwave Popcorn, 3 x 3.3oz, 10 boxes per case and 3 popcorn bags per box . | Lidl US TRADING | Food | Class II | 1 |
| 13 Aug 2020 | Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering… Event 86347 | Battelle Memorial Institute | Device | Class II | 1 |
| 5 Aug 2020 | Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular). | Shanghai United Imaging Healthcare Co., Ltd. | Device | Class II | 4 |
| 30 Jul 2020 | NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5 | Albek De Mexico S.A. De C.V. | Drug | Class II | 5 |
| 14 Jul 2020 | Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection. Event 86607 | Name withheld | Device | Class II | 1 |
| 14 Jul 2020 | FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems… | Name withheld | Device | Class II | 3 |
| 13 Jul 2020 | Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15 | Bausch Health Companies, Inc. | Drug | Class II | 1 |
| 13 Mar 2020 | SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. Event 85891 | Aesthetics Biomedical, Inc. | Device | Class II | 1 |
| 27 Feb 2020 | CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01, CMEAmerica Wall Charger Kit, REF 151-143XLP, Contents; Wall Charger,… | CME America LLC | Device | Class II | 1 |
| 29 Jan 2020 | Class IV New Era medical laser device Event 86706 | Inova Lasers LLC | Device | Class II | 1 |
| 24 Jun 2019 | 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only | OriGen Biomedical, Inc. | Device | Class II | 1 |
| 17 Jun 2019 | da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures. | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 23 Jan 2017 | Merge LIS | Merge Healthcare, Inc. | Device | Class II | 1 |