| 9 Oct 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-277-10 | ANI Pharmaceuticals, Inc. | Drug | Class III | 6 |
| 9 Oct 2020 | Dried Parsley packaged in the following ways: 1) World Market, Organic Parsley NET WT. 0.3 OZ (8.5 g), Distributed by Cost Plus, Inc., Alameda, CA UPC 2533 3251; 2) Organics, Organic Parsley, NET WT. 0.3 OZ (8.5 g), Distributed by Lucerne Foods, Inc., Pleasanton, CA UPC 0 79893 41109 5 3) Clearly Organic Best Choice,… | Red Monkey Foods Inc | Food | Class I | 2 |
| 9 Oct 2020 | The Spice Hunter Organic Parsley 0.23 oz. Jar UPC 8105701659 Case UPC 40081057016594 | Sauer Brands Inc - SLO | Food | Class I | 26 |
| 8 Oct 2020 | High Quality Organics Organic Parsley, Medium, Organic Parsley Fines 50 lbs. 25 lbs. 20 lbs. 0.25 lbs. | High Quality Organics | Food | Class I | 3 |
| 6 Oct 2020 | Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai, 200245, China for Sandoz Inc. Princeton, NJ 08540, NDC 0781-6172-22 Event 86568 | eVenus Pharmaceutical Laboratories | Drug | Class III | 1 |
| 6 Oct 2020 | Frozen raw Lobster Tail pastry 100 count, sold in 15LB, 24LB, 40.25LB cases Event 86571 | Ariola Foods Corp. | Food | Class II | 1 |
| 5 Oct 2020 | Solid White Albacore Tuna in Water; Sold under brand names of Bumble Bee and Kirkland Signature: Bumble Bee NET WT 8-7 oz. (198g) Total 56 oz. (3 lbs 8 oz) 1.59 kg); DR WT 8-5.2 oz. (144g_ total 40..8 oz (2 lb 9 oz) (1.15 kg); For Case UPC 86600-23061, the 8 Pack film UPC is 8660023061, can label UPC is 86600-23059… | Bumble Bee Foods, LLC | Food | Class II | 1 |
| 2 Oct 2020 | Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 2 Oct 2020 | Cinnamon Apple Crisps packaged under the following Brands and sizes: 1. Seneca, 2.5 ounce, UPC 0 18195-70100 8; 2. Clancy's 2.5 ounce, UPC 41498-27266. 3. Seneca, 0.7 ounce, UPC 0 18195-70140 4 4. Seneca 20 lb. 1" dices, product code 10134 | Seneca Foods Corporation | Food | Class I | 1 |
| 1 Oct 2020 | Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 1 Oct 2020 | Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144, UPC 8 50016 92317 2, NDC 70108-045-01);… Event 86546 | ASHTEL STUDIOS, INC. | Drug | Class I | 1 |
| 1 Oct 2020 | Trader Joe's Hatch Valley Salsa, 12 oz. jars packed into trays of 12 and shrink-wrapped, UPC: 0053 6806, Dist. & Sold Exclusively By: Trader Joe's, Monrovia, CA 91016 Event 86549 | Desert Premium Group, LLC | Food | Class II | 1 |
| 1 Oct 2020 | Watermelon 10 oz UPC Code: 681131180672; Watermelon 32 oz UPC Code: 681131180689; Watermelon Chunks 42 oz UPC Code: 681131180658; Watermelon Spears 16 oz UPC Code: 681131180665; RaceTrac Watermelon 5.5oz UPC Code: 74641000644 all packaged in clear plastic containers | Country Fresh Inc. | Food | Class I | 16 |
| 29 Sep 2020 | TRADER JOE S TRADER POTATO TOTS is frozen potatoes, SKU # 94904, retail bag has net wt. 2 lbs. Product is packaged in plastic bag. TRADER JOE S TRADER POTATO TOTS, master case is labeled as 0094 9040, frozen potatoes. There are 18/2 lbs. bags per case. The retail label is read in parts: "***SKU# 94904 *** TRADER… Event 86517 | J .R. Simplot Company | Food | Class II | 1 |
| 28 Sep 2020 | SKIPPY Super Chunk Peanut Butter 16.3oz UPC: 00037600110723 packaged in non-flexible plastic container | Hormel Foods Corporation | Food | Class II | 1 |
| 26 Sep 2020 | Marketside brand Cranberry Walnut Salad in 4.5 oz. plastic bowl with poly film lidding (6 bowls per case). UPC: 583243601 | Taylor Farms Tennessee, Inc. | Food | Class II | 1 |
| 25 Sep 2020 | NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816, | VistaPharm, Inc. | Drug | Class III | 1 |
| 25 Sep 2020 | Newly Weds Foods G44384 Cinnamon Snack Seasoning X1, 250 lbs. drum | Newly Weds Foods Inc | Food | Class I | 2 |
| 24 Sep 2020 | Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS) | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 2 |
| 24 Sep 2020 | Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01 | Leadiant Biosciences, Inc. | Drug | Class III | 1 |
| 24 Sep 2020 | Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59 | Legacy Pharmaceutical Packaging LLC | Drug | Class III | 1 |
| 23 Sep 2020 | RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 23 Sep 2020 | Meal Simple Taco Seasoned Salmon Over Fire Roasted Vegetables and Grains, Net WT. 10.8 oz (306g), Use By Date of 2020-9-24. Event 86490 | TAMPA BAY FISHERIES INC | Food | Class II | 1 |
| 23 Sep 2020 | Ground cinnamon. Packaged in bulk 50 lb. corrugated boxes with inside liner. Event 86472 | Kalustyan Corp. | Food | Class I | 1 |
| 23 Sep 2020 | WILD MUSHROOM BARLEY soup; Manufactured By: Hale & Hearty Soups; 2x9.6lbs; 13.8 net weight; Keep Refrigerated Event 86488 | Hale And Hearty Soups, LLC | Food | Class II | 1 |
| 22 Sep 2020 | ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 22 Sep 2020 | Ground Cinnamon 2% (CASSIA) packaged in 50 pound bag Event 86478 | Advanced Spice & Trading, Inc. | Food | Class I | 1 |
| 21 Sep 2020 | Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 21 Sep 2020 | Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M0033PK43022002, M0033PK62523002 Event 86583 | Name withheld | Device | Class I | 1 |
| 21 Sep 2020 | Shirakiku brand Black Fungus (Kikurage); 5 lb. bag, 6 x 5 lb. bags per case Item # 60403; UPC 0 74410 60403 5 Ingredients: Back Fungus, Contains: Sulfites Product of China Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA, 90670 | Wismettac Asian Foods, INC | Food | Class I | 1 |
| 19 Sep 2020 | Devonshire Bake Shop brand Lemon Italian Cream Cake, 10 , Yellow Cake Filled With Italian Lemon Cream, 12 slices Event 86451 | Name withheld | Food | Class II | 1 |
| 17 Sep 2020 | Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults. | Getinge Group Logistics America, LLC | Device | Class II | 1 |
| 17 Sep 2020 | Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens… | Quidel Corporation | Device | Class II | 1 |
| 17 Sep 2020 | NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01 | Acella Pharmaceuticals, LLC | Drug | Class I | 2 |
| 17 Sep 2020 | Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01. | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 17 Sep 2020 | Frozen Yellowfin Tuna Loins, Vacuum Packed, Imported and Distributed by Seafarers, Inc, 5-8 LBS, Product of Vietnam Event 86447 | SEAFARERS INC | Food | Class II | 1 |
| 17 Sep 2020 | Chocolate Ice Cream, 1 quart, UPC:87525200107. Packaged in paper quart container. | Homestead Creamery, Inc. | Food | Class I | 2 |
| 16 Sep 2020 | Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx Only, Distributed by arbor Atlanta, GA, NDC 24338-200-12 | Arbor Pharmaceuticals Inc. | Drug | Class III | 1 |
| 16 Sep 2020 | Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01 | Calvin Scott & Company, Inc. | Drug | Class II | 3 |
| 15 Sep 2020 | Quick Release Gait Belt, 60 | Medline Industries Inc | Device | Class II | 1 |
| 14 Sep 2020 | MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician. | Invivo Corporation | Device | Class III | 1 |
| 14 Sep 2020 | BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. | Becton Dickinson & Company | Device | Class II | 1 |
| 14 Sep 2020 | Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment… | Medline Industries Inc | Device | Class II | 8 |
| 11 Sep 2020 | VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite. | Skytron, Div. The KMW Group, Inc | Device | Class II | 1 |
| 11 Sep 2020 | Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 11 Sep 2020 | Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones. | Bien-Air Surgery Sa | Device | Class II | 5 |
| 11 Sep 2020 | Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016. | Genesis Partnership Company SA | Drug | Class II | 5 |
| 9 Sep 2020 | VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G | Ethicon, Inc. | Device | Class II | 1 |
| 9 Sep 2020 | EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use. | Encore Medical, LP | Device | Class II | 1 |
| 9 Sep 2020 | TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309 | Smith & Nephew, Inc. | Device | Class II | 40 |
| 9 Sep 2020 | Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3. | P & L Developments, LLC | Drug | Class III | 1 |
| 9 Sep 2020 | Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40 | PAI Holdings, LLC. dba Pharmaceutical Associates Inc | Drug | Class III | 1 |
| 9 Sep 2020 | Shatto Milk Company, Choc + Chip, Chocolate Chip Cookie and Vanilla Ice Cream Sammich, Net Wt. 4.5 oz, Shatto Milk Company, Osborn, MO | Shatto Milk Co | Food | Class II | 2 |
| 8 Sep 2020 | MediCult Vitrification Cooling Media, Model Number 12284001F | CooperSurgical, Inc. | Device | Class II | 1 |
| 8 Sep 2020 | System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. | GE Healthcare, LLC | Device | Class II | 5 |
| 8 Sep 2020 | AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma (101741000)… | Name withheld | Device | Class II | 2 |
| 7 Sep 2020 | Neoprobe GDS Control Unit, Model Number NPCU3 | Devicor Medical Products Inc | Device | Class III | 1 |
| 4 Sep 2020 | 1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia. Event 86417 | AB ULAX | Device | Class II | 1 |
| 4 Sep 2020 | Biomet Regenerex Primary Taper Cap Item Number 141269 | Biomet, Inc. | Device | Class II | 4 |
| 4 Sep 2020 | Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 3 Sep 2020 | (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206,… | Biomet, Inc. | Device | Class II | 1 |
| 3 Sep 2020 | Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01 | Akorn, Inc. | Drug | Class II | 1 |
| 2 Sep 2020 | GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051,… Event 86465 | Name withheld | Device | Class II | 1 |
| 2 Sep 2020 | Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere). | Biomet, Inc. | Device | Class II | 1 |
| 2 Sep 2020 | pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5. Event 86405 | pH-D Feminine Health | Drug | Class II | 1 |
| 2 Sep 2020 | Tim Campbell Farm flat parsley in wooden crate. Neither Net weight nor quantity stated on label; product is 30 count. Event 86348 | Tim Campbell Farm LLC | Food | Class I | 1 |
| 1 Sep 2020 | ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only. | Medline Industries Inc | Device | Class II | 1 |
| 1 Sep 2020 | AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1 AquaBplus B2 2000 / B1… | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 31 Aug 2020 | Langston Dual Lumen Catheter | Vascular Solutions, Inc. | Device | Class I | 4 |
| 31 Aug 2020 | AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. | Encore Medical, LP | Device | Class II | 1 |
| 31 Aug 2020 | BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001 | Roche Diagnostics Operations, Inc. | Device | Class II | 2 |
| 31 Aug 2020 | Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery. | Brainlab AG | Device | Class II | 1 |
| 31 Aug 2020 | Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopaque dilator; a 6 French, 7 cm… | Cook Inc. | Device | Class II | 2 |
| 31 Aug 2020 | BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ | Biomet 3i, LLC | Device | Class II | 7 |
| 31 Aug 2020 | PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution. | Ultradent Products, Inc. | Device | Class II | 1 |
| 31 Aug 2020 | Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 31 Aug 2020 | Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct). | Olympus Corporation of the Americas | Device | Class II | 1 |
| 28 Aug 2020 | VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory. | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 28 Aug 2020 | 365 Whole Foods Market Organic White Cheddar Popcorn, 4 oz. bag, UPC 099482428747, 16 retail units per wholesale case | Name withheld | Food | Class II | 6 |
| 27 Aug 2020 | Tina-quant Complement C4 ver.2, Catalog 05991994190 | Roche Diagnostics Operations, Inc. | Device | Class III | 2 |
| 27 Aug 2020 | Good & Gather Organic Kettle Corn, 7oz pkgs, film bags, 12 individual items per case. | Shearer'S Snacks | Food | Class II | 1 |
| 26 Aug 2020 | Pacific Xtreme (PTCA Balloon Dilation Catheter) | ev3 Inc. | Device | Class II | 1 |
| 26 Aug 2020 | Lucky Spoon Bakery Gluten Free Utterly Almond Muffins, 7.25 oz. plastic clam shell containing 6 muffins, UPC 8-50489-00305-0, P.O. Box 2954, Salt Lake City, UT 84110. 12 packages/case | Lucky Spoon Bakery, LLC | Food | Class II | 7 |
| 25 Aug 2020 | Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site | Genicon, Inc. | Device | Class II | 1 |
| 25 Aug 2020 | Change Healthcare Radiology Solutions 14.0 | CHANGE HEALTHCARE CANADA COMPANY | Device | Class II | 1 |
| 25 Aug 2020 | Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 25 Aug 2020 | Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 25 Aug 2020 | Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients… | Name withheld | Device | Class I | 3 |
| 24 Aug 2020 | Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries. | Alcon Research, LLC | Device | Class II | 1 |
| 24 Aug 2020 | Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of peripheral vascular pathology only.… | Boston Scientific Corporation | Device | Class II | 1 |
| 24 Aug 2020 | Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm. | Exactech, Inc. | Device | Class II | 2 |
| 24 Aug 2020 | Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816 NDC 64380-860-06 Event 86283 | Strides Inc. | Drug | Class II | 1 |
| 21 Aug 2020 | SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning. | Handicare AB | Device | Class II | 1 |
| 21 Aug 2020 | 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid Kit, Advance; Kit Product Code: 80-0892 d)… | North American Rescue LLC. | Device | Class II | 1 |
| 19 Aug 2020 | Dimension LOCI 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: RF627, SMN# 10471068 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 19 Aug 2020 | MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner. | Ansell Healthcare Products LLC | Device | Class II | 1 |
| 18 Aug 2020 | UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers. | Beckman Coulter Inc. | Device | Class II | 1 |
| 18 Aug 2020 | Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1 OXY-DX / "Alere iScreen Dx Single Dip Card… | Ameditech Inc | Device | Class II | 23 |
| 14 Aug 2020 | Dual Mobility Vivacit-E Bearing, Model Number 110031009 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 14 Aug 2020 | Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16 Event 86428 | Volu-Sol, Inc. | Drug | Class I | 1 |
| 13 Aug 2020 | SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or similar. Event 86351 | Name withheld | Device | Class II | 1 |
| 12 Aug 2020 | Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100 | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 12 Aug 2020 | Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. | Covidien, LP | Device | Class II | 9 |
| 7 Aug 2020 | RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044 | Encore Medical, LP | Device | Class II | 2 |
| 3 Aug 2020 | DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in preparation for the tibial baseplate keel. | Encore Medical, LP | Device | Class II | 1 |
| 3 Aug 2020 | Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 3 Aug 2020 | Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic,… | Riverpoint Medical, LLC | Device | Class II | 40 |
| 3 Aug 2020 | Item 80573 Greek Salad w/ Italian Dressing, Refrigerated, net wt. 6.5 OZ, packaged in Plastic Container. Item 80572 Greek Salad, Refrigerated, net wt. 11 OZ, packaged in Plastic Container. | Spokane Produce, Inc. | Food | Class I | 71 |
| 30 Jul 2020 | KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus. | Cardinal Health 200, LLC | Device | Class II | 1 |
| 29 Jul 2020 | "Nettle Meadow Artisan Cheese *** Fig Honey Fromage Frais*** Contains pasteurized goat and cows milk*** 5 oz.***" | LuMaZu, LLC dba Nettle Meadow | Food | Class II | 5 |
| 28 Jul 2020 | Control, Calibrator Verified, Triage BNP, Model ALR88755 | Medline Industries Inc | Device | Class II | 1 |
| 27 Jul 2020 | JINYINSHAN, KN95 PROTECTIVE MASK P1, 20 pieces Event 86241 | Office Depot Inc | Device | Class II | 1 |
| 24 Jul 2020 | DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease. | Ra Medical Systems, Inc. | Device | Class II | 1 |
| 24 Jul 2020 | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC). | Nuvasive Specialized Orthopedics Inc | Device | Class II | 1 |
| 21 Jul 2020 | Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control. Event 86380 | BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA | Device | Class II | 1 |
| 11 Jul 2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San… | 4e Brands North America, Llc | Drug | Class I | 10 |
| 6 Jul 2020 | NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101(30)100(10)4447754 CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery. | ICU Medical, Inc. | Device | Class II | 99 |
| 30 Jun 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) | Baxter Healthcare Corporation | Device | Class I | 4 |
| 22 Jun 2020 | Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 22 May 2020 | ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 10 Mar 2020 | SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room. | Skytron, Div. The KMW Group, Inc | Device | Class II | 1 |
| 15 Jan 2020 | Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 | Direct Rx | Drug | Class II | 2 |
| 20 Nov 2019 | ProxiDiagnost N90 | Philips North America, LLC | Device | Class II | 1 |
| 14 Oct 2019 | Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery. Event 86482 | Name withheld | Device | Class II | 1 |
| 12 Aug 2019 | ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19. | Zeus Scientific, Inc. | Device | Class II | 1 |
| 30 Apr 2019 | Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30 | Direct Rx | Drug | Class II | 1 |
| 12 Mar 2019 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90 | Direct Rx | Drug | Class II | 1 |
| 10 Dec 2018 | VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids | Luminex Corporation | Device | Class II | 1 |