| 14 Jan 2022 | Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50 | Mayne Pharma Inc | Drug | Class II | 1 |
| 11 Jan 2022 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1 | Exela Pharma Sciences LLC | Drug | Class II | 1 |
| 10 Jan 2022 | Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080 | Compass Health Brands (Corporate Office) | Device | Class II | 1 |
| 10 Jan 2022 | Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3 (89388) | Individual firm, name withheld | Drug | Class III | 1 |
| 10 Jan 2022 | Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408. | Ingenus Pharmaceuticals Llc | Drug | Class II | 1 |
| 7 Jan 2022 | Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04 | VistaPharm, Inc. | Drug | Class II | 1 |
| 5 Jan 2022 | Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505. | Mylan Pharmaceuticals Inc | Drug | Class I | 1 |
| 5 Jan 2022 | Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02. | Akorn, Inc. | Drug | Class II | 1 |
| 4 Jan 2022 | Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in… | Individual firm, name withheld | Drug | Class III | 9 |
| 3 Jan 2022 | Everything Swapples, Net Wt. 11.14 OZ, UPC 8 64390 00021 3 (89359) | SWAP FOODS LLC | Food | Class II | 1 |
| 2 Jan 2022 | CHICKEN SALAD Croissant NET WT. 7.8OZ (221g) Perishable, Keep Refrigerated Ingredients: Chicken Salad***Savory Mayonnaise Base***Croissant***Lettuce. CONTIANS EGG, MILK, WHEAT, SOY, MAY CONTAIN TREE NUTS. Dist. By: Renaissance Food Group, LLC 4322 Moreland Ave. Conley, GA 30288 UPC 8 26766 15578 1 | Renaissance Food Group, LLC | Food | Class I | 1 |
| 31 Dec 2021 | Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00 | Rubicon Research Private Limited | Drug | Class II | 1 |
| 31 Dec 2021 | MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons. | Teva Pharmaceuticals USA | Drug | Class II | 2 |
| 30 Dec 2021 | Metformin 750 mg Extended Release NDC # 70518-2920-00 | RemedyRepack Inc. | Drug | Class II | 1 |
| 29 Dec 2021 | Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 29 Dec 2021 | Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645 | RemedyRepack Inc. | Drug | Class II | 1 |
| 27 Dec 2021 | Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02 | Padagis US LLC | Drug | Class II | 1 |
| 27 Dec 2021 | Macaroni & Cheese, Macarrones con Queso; 3-5 lb pouches/bolsas, NET WT/PESO NETO 240 OZ (15 LB) 6.80 kg; distributed by Gordon Food Service, Reorder No. 540061, Vendor Item # 4357505, Perishable. Keep Refrigerated. Perecedero. Mantener Refrigerado. (89313) | Sandridge Food Corporation | Food | Class I | 1 |
| 26 Dec 2021 | Aplenty Rotini with Plant based Bolognese Meal Kit 24oz (89304) | Joseph Seviroli Inc. | Food | Class I | 1 |
| 23 Dec 2021 | Moor Herbs Healthy Beauty Angel Formula packed in 16oz. plastic containers (89299) | Individual firm, name withheld | Food | Class I | 1 |
| 22 Dec 2021 | SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT) | Covidien, LP | Device | Class II | 1 |
| 22 Dec 2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01. | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 21 Dec 2021 | SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24. | Lohxa, LLC | Drug | Class I | 1 |
| 21 Dec 2021 | Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50 | Ascend Laboratories, LLC | Drug | Class II | 1 |
| 21 Dec 2021 | "Haifa Smoked Fish and Caviar*** Turbot Cold Smoked***Net Wt 8 0z." (89258) | D & M Smoked Fish, Inc. | Food | Class I | 1 |
| 20 Dec 2021 | Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H. | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 20 Dec 2021 | 100% Plant-Based Dream Pops Vanilla Sky Bites UPC 854097008254 | Individual firm, name withheld | Food | Class I | 4 |
| 18 Dec 2021 | Fish-Pickle is packaged in yellow plastic pouch. No listed weight, no UPC. Product is imported from Jampani Foods SRT 252 Sanathnagar, Hyderabad-500018. The label is read in parts: "***Fish-Pickle ***Ingredients: Raw Fish, Ginger Garlic Paste, Turmeric Powder, Chilli Powder, Salt, Olive/Sun Flower Oil, Hot Spices,… | Aroma Meats LLC | Food | Class II | 12 |
| 17 Dec 2021 | Nature's Own Honey Wheat Bread, NET WT 20 oz (1LB 4 OZ) 567g, DISTRIBUTED BY FLOWERS BAKERIES, LLC THOMASVILLE, GA 31757 Single loaf UPC 0 72250 03706 8 & Double pack UPC 0 72250 00539 5 | Flowers Foods (Corporate Offices) | Food | Class I | 1 |
| 17 Dec 2021 | Fresh Flour Tortillas are packaged in a clear Ziploc style plastic bag. The weight per package is 1.323 lbs/600 grams. The label is read in parts: "***Fresh Flour Tortillas ***Flour, water, organic palm shortening, salt, baking powder*** ww.localfixe.com***". | Local Fixe LLC | Food | Class II | 6 |
| 16 Dec 2021 | Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300 | Draeger Medical, Inc. | Device | Class II | 1 |
| 16 Dec 2021 | 8 Grain Bread, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package. | Bosket Bread Company, LLC | Food | Class II | 15 |
| 15 Dec 2021 | Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3 | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class I | 1 |
| 13 Dec 2021 | Chili & Cheese Brat on Pretzel Bun, Item Number 1098, Net Wt. 6.5 oz(185g), UPC 7 47804-01098 8. Keep Refrigerated. Packaged under the following brands: 1. Grabn'Go, MFG BY: KF Foods, Green Bay, WI 54313; 2. Fox River Vending Inc. Dst By: Fox River Appleton WI, 54915; 3. Home Town Deli, Dst By: Hometown Vending,… (89220) | Kitchen Fresh Foods, LLC | Food | Class II | 1 |
| 13 Dec 2021 | Joy's Gourmet Blast Off! Bloody Mary Mix, Net Wt. 24 Oz (89230) | Joy's International Foods, Incorporated | Food | Class II | 1 |
| 13 Dec 2021 | ZOCALO AJI LIMO DRIED CHILI PODS- ORGANIC, Dried Aji Peppers for consumer consumption. Product is vacuum sealed in plastic bag. Net weight per bag 1.25 oz (35 g), 6 bags per case. Product of Peru. UPC 8 32924 00879 0. The product label is read in parts: "***ZOCALO gourmet *** ORGANIC AJI LIMO ***The Aji limo chili is… | Power Selles Imports dba Culinary Collective | Food | Class II | 1 |
| 11 Dec 2021 | Trader Joe's Soycutash, Item # 99319. A mix of Sweet Corn, Shelled Edamame, and Red Bell Peppers. Net Wt. 16 oz. (1 lb.) 454g. Keep Frozen. UPC 0099-3197. Dist & Sold Exclusively By: Trader Joe's Monrovia, CA 91016 (89237) | Sno Pac Foods, Inc | Food | Class II | 1 |
| 10 Dec 2021 | GODAVARI brand APRICOTS, packaged in 7 oz (UPC 0 03658 50001 4) and 14 oz (UPC 0 03657 5001 5) clear plastic-film bags with the GODAVARI brand label on the front. Each bag is filled with orange-colored dried apricots that can be seen through the bag. (89207) | Bokhary Foods, Inc. | Food | Class I | 1 |
| 10 Dec 2021 | Vemondo Vegan Coconut & Cocoa Non-Dairy Dessert Cones 4-3.7 fl ounces (110 mL) cones UPC 4 056489 468646 | Lidl US Operations, LLC | Food | Class II | 2 |
| 9 Dec 2021 | Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i Anesthesia System C30 6888530 07325710010624… | Getinge Usa Sales Inc | Device | Class I | 1 |
| 9 Dec 2021 | greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 9 Dec 2021 | ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 9 Dec 2021 | Diet Snapple Tea Peach Tea 16 oz. packaged in PET bottle. Expiration Date: February 5, 2022. UPC single bottles: 0 7618300314 5. UPC 12 Pack 0 7618300813 3. (89191) | Individual firm, name withheld | Food | Class II | 1 |
| 9 Dec 2021 | butter almond HOWLING COW THE ICE CREAM OF NC STATE UNIVERSITY One Pint (473 ml) Ingredients: Milk, Cream, Sugar, Almonds***Stabilizer***Carmel Color and Natural Flavor. Contains milk, almonds Proudly distributed by Hunter Farms High Point, NC 27262 UPC 0 74336 65079 6 (89210) | Individual firm, name withheld | Food | Class I | 1 |
| 8 Dec 2021 | Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001. (89126) | Individual firm, name withheld | Device | Class II | 1 |
| 8 Dec 2021 | Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 8 Dec 2021 | happi foodi , Roasted Russets and Asparagus, 10 oz frozen bowl, 8 packages per case, Keep Frozen DOM- 05/20/2021 (89301) | Prepared Meals Co | Food | Class III | 1 |
| 7 Dec 2021 | GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610 | DePuy Orthopaedics, Inc. | Device | Class II | 8 |
| 6 Dec 2021 | Alinity m System, Part No. 08N53-002 | Abbott Molecular, Inc. | Device | Class II | 1 |
| 6 Dec 2021 | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for… | ev3 Inc. | Device | Class I | 2 |
| 6 Dec 2021 | Alinity m System, Part No. 08N53-002 | Abbott Molecular, Inc. | Device | Class II | 1 |
| 6 Dec 2021 | LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 | Covidien Llc | Device | Class II | 1 |
| 6 Dec 2021 | Alinity m System, Part No. 08N53-002 | Abbott Molecular, Inc. | Device | Class II | 1 |
| 6 Dec 2021 | Alinity m System, Part No. 08N53-002 | Abbott Molecular, Inc. | Device | Class II | 1 |
| 6 Dec 2021 | Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6 | Medique Products | Drug | Class II | 3 |
| 6 Dec 2021 | kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1 (89186) | Valisa MFG LLC | Drug | Class I | 1 |
| 3 Dec 2021 | ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC (89275) | Konica Minolta Healthcare Americas, Inc. | Device | Class II | 1 |
| 3 Dec 2021 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2 | Gilead Sciences, Inc. | Drug | Class I | 1 |
| 3 Dec 2021 | Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30 | Akorn, Inc. | Drug | Class III | 2 |
| 3 Dec 2021 | BUBS Naturals Fountain of Youth Formula; Collagen Protein; Support for Hair, Skin & Nails; Biotin, Antioxidant, Vitamin C; Maqui Berry Net Wt. 10.16 oz. (288 g) (89145) | Slayer Forever, LLC dba BUBS Naturals | Food | Class I | 1 |
| 2 Dec 2021 | Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. | Torrent Pharma Inc. | Drug | Class II | 1 |
| 1 Dec 2021 | Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 30 Nov 2021 | Regard, T AND A - Rogers, sterilized convenience kits | ROi CPS LLC | Device | Class II | 1 |
| 30 Nov 2021 | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089 | Straumann USA LLC | Device | Class II | 2 |
| 30 Nov 2021 | Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64 | Teligent Pharma, Inc. | Drug | Class I | 2 |
| 30 Nov 2021 | Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416 (89138) | Aroma Release Technologies Inc | Drug | Class I | 1 |
| 30 Nov 2021 | Giant Eagle, Diced Green Peppers, 10 oz. poly bags and 22# cases, also poly bags and cartons, 12/10 oz. bags per case and bulk 22 lbs. bags (89148) | Frozen Food Development | Food | Class II | 1 |
| 29 Nov 2021 | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 | Ion Beam Applications S.A. | Device | Class II | 1 |
| 29 Nov 2021 | Infant Heel Warmers w/strap, Reference # 989805603201 1223 | Philips North America Llc | Device | Class II | 4 |
| 29 Nov 2021 | PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L | ULTRAtab Laboratories, Inc. | Drug | Class II | 1 |
| 29 Nov 2021 | Giant Eagle Diced Green Peppers, 10 oz. 283 g, Frozen bag, 12 packages per case , Best By 10/14/2023 . | Giant Eagle, Inc. | Food | Class II | 1 |
| 26 Nov 2021 | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 | Philips North America Llc | Device | Class II | 1 |
| 24 Nov 2021 | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000" | Reflexion Medical, Inc. | Device | Class II | 1 |
| 24 Nov 2021 | DBB-06 Hemodialysis Delivery System (88641) | Nikkiso Ltd - Shizuoka Plant | Device | Class II | 1 |
| 24 Nov 2021 | Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109 | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 23 Nov 2021 | 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies,… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 22 Nov 2021 | UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile. (89184) | Uromedica Inc. | Device | Class II | 1 |
| 22 Nov 2021 | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 | Gentherm Medical, LLC | Device | Class II | 1 |
| 22 Nov 2021 | VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 1 |
| 19 Nov 2021 | Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System. | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 1 |
| 19 Nov 2021 | Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport. (89204) | Ki Mobility Llc | Device | Class III | 1 |
| 19 Nov 2021 | Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 | DiaSorin Molecular LLC | Device | Class II | 1 |
| 19 Nov 2021 | SOMATOM Confidence -Computed tomography systems Model 10590100 | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 18 Nov 2021 | Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 17 Nov 2021 | Senior Living Arial Emergency and Nurse Call Systems | Stanley Security Solutions Inc | Device | Class II | 1 |
| 17 Nov 2021 | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile (89117) | Medshape, INC. | Device | Class II | 1 |
| 16 Nov 2021 | Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM | Abbott | Device | Class II | 1 |
| 16 Nov 2021 | Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000. | Ohio Medical Corporation | Device | Class II | 1 |
| 12 Nov 2021 | Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224 | Philips North America Llc | Device | Class II | 1 |
| 12 Nov 2021 | Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG | Invacare Corporation | Device | Class II | 3 |
| 12 Nov 2021 | Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01. | SterRx, LLC | Drug | Class II | 26 |
| 10 Nov 2021 | iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min. (89161) | Tapemark Company | Device | Class III | 1 |
| 9 Nov 2021 | RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD. | Biomerieux Inc | Device | Class II | 1 |
| 9 Nov 2021 | Boba Origin Brown-Sugar Milk Tea 100% WHEY PROTEIN ISOLATE 5.5g BCAA INGREDIENTS: Whey Protein Isolate, Black Tea, Coconut Milk, Powder, Sunflower Lecithin, Sucralose. Manufactures for BOBA ORIGIN LLC 15421 Gale Ave #93161 City of Industry, CA 91715 UPC 6 56750 00764 8 | NutraCap Labs LLC | Food | Class I | 106 |
| 8 Nov 2021 | QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 | Qiagen Sciences LLC | Device | Class II | 1 |
| 4 Nov 2021 | FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test (89028) | Migo Trading LLC | Device | Class II | 1 |
| 3 Nov 2021 | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 | Haag-Streit USA Inc | Device | Class II | 2 |
| 2 Nov 2021 | Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1 | Flower Orthopedics Corporation | Device | Class II | 1 |
| 29 Oct 2021 | Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033,… | Philips North America Llc | Device | Class II | 1 |
| 26 Oct 2021 | Tuna, raw sold at meat counter and wrapped in butcher paper at point of purchase. (89202) | Sant' Elia Operations, LLC | Food | Class II | 1 |
| 22 Oct 2021 | Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 21 Oct 2021 | iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301 | AMO Manufacturing USA, LLC | Device | Class II | 2 |
| 20 Oct 2021 | Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564 | Biomeme, Inc. | Device | Class II | 1 |
| 19 Oct 2021 | Model B35200 - Percept PC BrainSense Implantable Neurostimulator (88889) | Individual firm, name withheld | Device | Class II | 1 |
| 15 Oct 2021 | Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM… (88998) | Individual firm, name withheld | Device | Class II | 1 |
| 12 Oct 2021 | Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5.… | Medtronic Perfusion Systems | Device | Class II | 1 |
| 11 Oct 2021 | Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4:… (89134) | Forbes Rehab Services Inc | Device | Class II | 1 |
| 28 Sep 2021 | The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4 (89289) | Revive Personal Products Company | Drug | Class II | 1 |
| 22 Sep 2021 | da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 22 Sep 2021 | VIDAS PRG Progesterone, REF 30409-01 | bioMerieux, Inc. | Device | Class II | 16 |
| 27 Aug 2021 | Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032 (89314) | PTW NORTH AMERICA CORPORATION | Device | Class II | 1 |
| 23 Aug 2021 | Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29 | Teligent Pharma, Inc. | Drug | Class II | 1 |
| 27 Jul 2021 | EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908. | Perrigo Company PLC | Drug | Class II | 30 |
| 16 Apr 2021 | ARIES HSV 1&2 Assay, Part Number/REF 50-10017 | Luminex Corporation | Device | Class II | 1 |
| 18 Mar 2021 | Gentueri Viral Transport Medium (VTM), Sterile, IVD (89337) | Gentueri Inc | Device | Class II | 1 |
| 16 Dec 2020 | KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299. | Microbiologics Inc | Device | Class II | 1 |