| 13 Apr 2023 | C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Drug | Class II | 1 |
| 6 Apr 2023 | Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8. | Pharma Nobis LLC | Drug | Class II | 1 |
| 6 Apr 2023 | 0.6 oz. jalapeno cheese sticks. P.6LGSTICKJL. Cheese sticks are packed in clear plastic pouches with a nitrogen flush. Pouches contain about 150 sticks, with 2 pouches per case. Cases can weigh between 9 lbs. - 11 lbs. (92086) | Gilman Cheese Corporation | Food | Class II | 1 |
| 6 Apr 2023 | Trader Joe's Chickenless Crispy Tenders Net Wt, 8.1 OZ (230g) UPC 0097 8996 Packaged in a plastic bag (92069) | Individual firm, name withheld | Food | Class II | 1 |
| 4 Apr 2023 | GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System (92051) | Individual firm, name withheld | Device | Class II | 1 |
| 4 Apr 2023 | White Castle Chicken Slider Individual sandwiches packaged as two sandwiches - 16 packages per case Unit Size 5.68oz/161g (92057) | White Castle System | Food | Class II | 1 |
| 3 Apr 2023 | Hiland Fat Free Chocolate Milk Vitamin A&D Naturally Flavored Half Pint (236 mL) UPC 72060 00133 4 packaged in a paper carton | Hiland Dairy Foods Company LLC | Food | Class II | 1 |
| 3 Apr 2023 | 61404 Butterball Turkey Stick MB (meal box) | E S Foods | Food | Class II | 15 |
| 31 Mar 2023 | 1. Nature's Promise Organic Raspberries 10oz; Stand up plastic pouch in corrugated box; Product of Chile; 8x12 oz bags per case; 2. Stater Bros. Red Raspberries 12oz; Stand up plastic pouch in corrugated box; Product of USA; 12x12 oz bags per case; 3. SB Raspberries 12 oz; Stand up plastic pouch in corrugated box;… (92011) | B.C. Frozen Foods | Food | Class II | 1 |
| 31 Mar 2023 | SimplyProtein¿ Peanut Butter Chocolate Crispy 15-1.41 OZ (40 g) bar. (UPC 6 86207 00914 7) Sold in 15-count variety pack with two other flavors (Lemon Coconut and Chocolate Sea Salt) NET WT 21/16 OZ (600 g). Outside carton UPC 6 86207 80906 8. Packaged in a carboard box. Individually wrapped in plastic. (92022) | Wellness Natural USA Inc. | Food | Class II | 1 |
| 29 Mar 2023 | Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08. | Accord Healthcare, Inc. | Drug | Class III | 1 |
| 29 Mar 2023 | Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India; Distributed by: Sun Phamaceutical Industries, Inc.,… | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class III | 1 |
| 29 Mar 2023 | Frisch's Tuna Salad packaged in 4lb plastic tubs - sold individually (92009) | FKC LLC | Food | Class II | 1 |
| 28 Mar 2023 | Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton | Abbott Laboratories | Food | Class II | 1 |
| 28 Mar 2023 | Sysco Imperial Caesar Dressing NET CONTENTS 1 GAL (3.78 l) INGREDIENTS: Soybean Oil, Water, Distilled Vinegar, Parmesan Cheese***High Fructose Corn Syrup, Salt, Contains less than 2% of Ground Mustard, Spice, Dried Garlic, Anchovy Paste***Sodium Benzoate***Calcium Disodium EDTA***Xanthan Gum, Propylene Glycol,… (91978) | Winland Foods, Inc. | Food | Class I | 1 |
| 27 Mar 2023 | JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM | Smith & Nephew, Inc. | Device | Class II | 1 |
| 27 Mar 2023 | Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150, Office Use Only, Not for Resale. Secondary… | Pine Pharmaceuticals, LLC | Drug | Class III | 1 |
| 27 Mar 2023 | Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19 | Teva Pharmaceuticals USA Inc | Drug | Class III | 1 |
| 27 Mar 2023 | Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3 | Preferred Pharmaceuticals, Inc. | Drug | Class II | 3 |
| 27 Mar 2023 | Kagome Worchester Sauce 16.9 fl., oz plastic bottles | North American Food Dist. Co., Inc. | Food | Class I | 2 |
| 24 Mar 2023 | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CUFFED TRACH CAN; 10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF; 10UN10A, 10.0MM UNCUFF TRACH TUBE X1; 10UN10H, 10.0MM SHILEY CUFFLESS TRACH C;… | Covidien | Device | Class I | 1 |
| 23 Mar 2023 | Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9 | Preferred Pharmaceuticals, Inc. | Drug | Class II | 17 |
| 23 Mar 2023 | HyVee Hamburger Chili Macaroni Skillet Meal, 5.2oz retail carton. UPC: 0 75450-08552 5 | Gilster-Mary Lee Corp. | Food | Class I | 1 |
| 23 Mar 2023 | Volupta Organic Black Chia Seeds 64 oz. Best By: 10/31/2025 Stand up pouch. Product of Paraguay (91960) | NSI Group LLC | Food | Class I | 1 |
| 23 Mar 2023 | Tried and True Granola Co. Naturally Sweetened Granola packaged in 20lb bulk plastic bags and 14oz plastic containers (91961) | Bakery Barn | Food | Class II | 1 |
| 23 Mar 2023 | Sheila G's Gluten Free Reese's Pieces Brownie Brittle, 4 oz bag (Retail bag UPC 711747 011562) | Kar Nut Products Company | Food | Class I | 1 |
| 22 Mar 2023 | BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213 | Becton Dickinson & Co. | Device | Class II | 1 |
| 22 Mar 2023 | Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30. | Direct Rx | Drug | Class II | 3 |
| 22 Mar 2023 | Natural Pak brand Bacon Glaze is packaged in 22.9oz (649g), white, cylindrical, plastic containers; Ingredients: Demerara sugar, honey granules, brown sugar, maple sugar, paprika, spices (black pepper, cinnamon, allspice, clove, natural flavors (maple, honey, cinnamon, clove), parsley. | Victoria Gourmet, Inc. | Food | Class III | 2 |
| 20 Mar 2023 | ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe | Baxter Healthcare Corporation | Device | Class II | 1 |
| 20 Mar 2023 | Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03 | RemedyRepack Inc. | Drug | Class II | 14 |
| 20 Mar 2023 | FURIKAKE SEASONED ROASTED SEAWEED FLAKES SEAFOOD Product number: 38245 Brand name: Shirakiku Distributed by: Wismettac Asian Foods, Inc. 13409 Orden Drive Santa Fe Springs, CA 90670 | Wismettac Asian Foods, Inc. | Food | Class III | 2 |
| 17 Mar 2023 | Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation (91957) | Individual firm, name withheld | Device | Class II | 1 |
| 17 Mar 2023 | Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05 | Ascend Laboratories, LLC | Drug | Class II | 1 |
| 17 Mar 2023 | Gerber GoodStart SoothePro Infant Formula with Iron. Milk Based Powder. Stage 1, 0 - 12 Months. Nestle Infant Nutrition, Arlington, VA 22209. Packaged in the following sizes: 1. Net Wt 12.4 oz. (351 g) (6 cans per case) UPC 050000-62400 3 2. Net Wt 30.6 oz. (1.91 lb / 867 g) (4 cans per case) UPC 0 50000-49498 9 3.… (91912) | Individual firm, name withheld | Food | Class I | 1 |
| 17 Mar 2023 | Kagome Worcester Sauce 6/60 fl oz. Ingredients: Water, Sugar, Salt, Fermented Vinegar, Glucose, Tomato Extract, Caramel Coloring, Protein Hydrolysate, Onion Extract, Garlic Extract, Thickener (Guar Gum), Spice, Onion Concentrate, Licorice, Spice Extract, Chili Pepper Extract, Apple Juice, Carrot Extract, Mushroom… | Mutual Trading Company Inc. | Food | Class I | 3 |
| 17 Mar 2023 | WEGMANS STEAM CHOPPED SPINACH 12/12OZ Poly steam bags (91924) | NORTERA FOODS USA | Food | Class II | 1 |
| 17 Mar 2023 | Magnesium Citrate Tribasic Hydrate, USP, Ultrafine Powder sold in bulk 55 lb fiber box. | Jost Chemical Co | Food | Class III | 1 |
| 16 Mar 2023 | Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13 (91911) | Focus Health Group Inc | Drug | Class III | 1 |
| 16 Mar 2023 | Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7. | Amerisource Health Services LLC | Drug | Class II | 1 |
| 16 Mar 2023 | Frozen Organic Strawberries, Kirkland Signature, frozen, net wt. 4lb., 9 packages per case, Costco Item 904984. UPC 096619140404. Distributed by Costco Warehouse Corporation, Seattle, WA. Product of Mexico. | Scenic Fruit Company, LLC | Food | Class I | 3 |
| 16 Mar 2023 | Impossible Chicken Nuggets Made From Plants packaged in the following names and package sizes: 1. Wild Nuggies, Net Wt. 13.5oz (383g), UPC 8 16697-02039 5; 2. Chicken Nuggets, Net Wt. 32 oz (907g), UPC 8 16697-02042 5; 3. Chicken Nuggets, Net Wt. 13.5oz (383g), UPC 8 16697-02114 9. Contains No Animal Products. Fully… | Impossible Foods Inc | Food | Class II | 2 |
| 15 Mar 2023 | Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 15 Mar 2023 | Mary s Gone Crackers Super Seed Seaweed & Black Sesame Crackers Product Item number: 10033380101 UPC: 8 53665 00510 7 (91908) | Individual firm, name withheld | Food | Class II | 1 |
| 15 Mar 2023 | 4-lb. bags of Kirkland Signature Frozen Organic Strawberries 9 bags per carton - 36 lbs. per carton | California Splendor, Inc. | Food | Class I | 3 |
| 14 Mar 2023 | Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60. | Ascend Laboratories, LLC | Drug | Class II | 2 |
| 14 Mar 2023 | Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10 | Hetero USA Inc | Drug | Class II | 1 |
| 13 Mar 2023 | Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534 | Direct Rx | Drug | Class II | 11 |
| 13 Mar 2023 | Biltmore Smoked Sockeye Salmon - 4 oz | Seven Seas International USA LLC | Food | Class I | 1 |
| 13 Mar 2023 | Almost Famous Popcorn Poppy Chow, 9.9 oz bag (UPC 8 5001151513) (91893) | Individual firm, name withheld | Food | Class II | 1 |
| 13 Mar 2023 | Perrona Hot Sauce Original with Chiltepin Peppers 5 fl oz (148ml) UPC 75 03016 55507 4 packaged in a PET bottle, 12 bottles per case | TIPPCON LLC | Food | Class III | 3 |
| 13 Mar 2023 | Matiz Piparra Peppers are packaged in a clear glass jar, net wt. 4lb. (1.8kg), drained wt. 25oz (700g). Product is shelf stable. UPC 832924005768. Produced By Conservas Rubio - Navarra, Spain. Imported By Matiz A Culinary Collective Company Lynnwood, WA. | Power Selles Imports dba Culinary Collective | Food | Class II | 1 |
| 10 Mar 2023 | stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure | Howmedica Osteonics Corp. | Device | Class II | 2 |
| 10 Mar 2023 | Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 | Fresenius Kabi USA, LLC | Device | Class I | 1 |
| 10 Mar 2023 | Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03… | Alcon Research, LLC | Device | Class II | 1 |
| 10 Mar 2023 | Purity Sweet Acidophilus 1% Lowfat Milk packaged in paper half pint cartons - 50 cartons per case, Keep Refrigerated (91946) | DFA Dairy Brands Fluid, LLC | Food | Class II | 1 |
| 9 Mar 2023 | VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976 | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 1 |
| 9 Mar 2023 | Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201 | Philips North America Llc | Device | Class II | 2 |
| 8 Mar 2023 | MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device | Medacta Usa Inc | Device | Class II | 6 |
| 8 Mar 2023 | AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or… | Radiometer Medical ApS | Device | Class II | 1 |
| 8 Mar 2023 | FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit) | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 8 Mar 2023 | Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System | NeuroLogica Corporation | Device | Class II | 1 |
| 8 Mar 2023 | MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02 | Pfizer Inc. | Drug | Class III | 1 |
| 7 Mar 2023 | REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L | Compass Health Brands (Corporate Office) | Device | Class II | 1 |
| 7 Mar 2023 | Clio Strawberry Granola & Yogurt Parfait Bar Net Wt. 1.94 OZ (55g ) UPC: 854021008152 Packaged in a cardboard box. | Clio LLC | Food | Class I | 1 |
| 7 Mar 2023 | Dr. Rima Recommends The Silver Solution Immune System Support Dietary Supplement Nano Silver 10 ppm 16 fl. oz. (473 ml) (91571) | Natural Solutions Foundation | Food | Class II | 1 |
| 6 Mar 2023 | VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500 | Maquet Cardiovascular, LLC | Device | Class II | 3 |
| 6 Mar 2023 | Rold Gold Original Classic Tiny Twists Pretzels in 16oz UPC 2840004768 packaged in a flexible bag | Frito-Lay, Inc. Headquarters | Food | Class III | 1 |
| 2 Mar 2023 | Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile. | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 2 Mar 2023 | NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110 | Angiodynamics, Inc. | Device | Class II | 1 |
| 2 Mar 2023 | Cirq Arm System 2.0 | Brainlab AG | Device | Class II | 1 |
| 2 Mar 2023 | Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11. | Endo Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 1 Mar 2023 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057 | Shanghai United Imaging Healthcare Co., Ltd. | Device | Class II | 1 |
| 1 Mar 2023 | Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman… | Elekta Instrument AB | Device | Class II | 1 |
| 1 Mar 2023 | Atrium Pneumostat Chest Drain Valve, Part Number 16100 | Atrium Medical Corporation | Device | Class II | 2 |
| 1 Mar 2023 | Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010 | Covidien, LP | Device | Class II | 4 |
| 1 Mar 2023 | Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135; Color Cuff Dual Port, Single Bladder 34 (Purple), Quick… | Stryker Sustainability Solutions | Device | Class II | 1 |
| 1 Mar 2023 | Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis | Coloplast Manufacturing US, LLC | Device | Class II | 17 |
| 1 Mar 2023 | Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities | Stryker Corporation | Device | Class II | 6 |
| 1 Mar 2023 | CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 | Terumo Cardiovascular Systems Corporation | Device | Class II | 3 |
| 1 Mar 2023 | Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B,… | Philips Respironics, Inc. | Device | Class I | 3 |
| 28 Feb 2023 | EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108 | Encore Medical, LP | Device | Class II | 1 |
| 27 Feb 2023 | CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384 | Zimmer, Inc. | Device | Class II | 1 |
| 24 Feb 2023 | Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567 (91884) | Tobii Dynavox Llc | Device | Class II | 1 |
| 24 Feb 2023 | Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50, | Iradimed Corporation | Device | Class II | 1 |
| 24 Feb 2023 | Geisha Medium Shrimp; WT 4OZ(113g) (91720) | Kawasho Foods USA, Inc | Food | Class II | 1 |
| 23 Feb 2023 | Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip | Olympus Corporation of the Americas | Device | Class II | 1 |
| 23 Feb 2023 | Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus… | Remote Diagnostic Technologies Ltd. | Device | Class II | 1 |
| 23 Feb 2023 | Seasoned Pickled Radish distributed in un-labeled plastic containers 6oz, 8oz, 12oz, and 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail store. | Lemonland Food Corp | Food | Class II | 31 |
| 22 Feb 2023 | Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 21 Feb 2023 | SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 (91869) | Individual firm, name withheld | Device | Class II | 1 |
| 21 Feb 2023 | Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 | Preat Corp | Device | Class II | 1 |
| 21 Feb 2023 | BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD | Bio-Rad Laboratories, Inc. | Device | Class II | 2 |
| 21 Feb 2023 | PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples | Entopsis , Inc. | Device | Class II | 7 |
| 21 Feb 2023 | Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile | Biosense Webster, Inc. | Device | Class II | 2 |
| 20 Feb 2023 | SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 2 |
| 20 Feb 2023 | Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350 (91782) | Moberg Research, Inc. | Device | Class II | 1 |
| 17 Feb 2023 | Agilent Resolution ctDx FIRST Sample Collection Kit, 500032 (91863) | AGILENT TECHNOLOGIES INC./US | Device | Class III | 1 |
| 17 Feb 2023 | Stainless Steel Water Bottle The product comes in four sizes: 32 oz., 24 oz., 20 oz., and 13 oz. (91755) | Individual firm, name withheld | Food | Class II | 1 |
| 16 Feb 2023 | thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive… | Solta Medical Inc | Device | Class II | 1 |
| 16 Feb 2023 | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine… | Medtronic Sofamor Danek USA Inc | Device | Class II | 5 |
| 15 Feb 2023 | Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 15 Feb 2023 | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328. | Azurity Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 14 Feb 2023 | KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter. | Pro-Dex Inc | Device | Class II | 1 |
| 14 Feb 2023 | Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm) | Edwards Lifesciences, LLC | Device | Class II | 2 |
| 14 Feb 2023 | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest | Defibtech, LLC | Device | Class II | 1 |
| 13 Feb 2023 | FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | Device | Class I | 3 |
| 13 Feb 2023 | Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060 | CooperSurgical, Inc. | Device | Class II | 1 |
| 10 Feb 2023 | da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 10 Feb 2023 | COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures. | Covidien | Device | Class II | 1 |
| 10 Feb 2023 | Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. | Philips Respironics, Inc. | Device | Class I | 1 |
| 8 Feb 2023 | Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101; g) DBM T43101INT… | Medtronic Sofamor Danek USA Inc | Device | Class II | 12 |
| 8 Feb 2023 | Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25 | Apollo Care | Drug | Class II | 1 |
| 5 Feb 2023 | Danncy Vainilla Pure Mexican Vanilla Extract Clear Gluten Free Produced by Juan Miguel Anzaldua Gutierrez NET 33.8 FL OZ (1.0L) UPC 7503000781137 packaged in clear plastic bottles and Danncy Vainilla Pure Mexican Vanilla Extract Gluten Free Produced by Juan Miguel Anzaldua Gutierrez NET 33.8 FL OZ (1.0L) UPC… (91573) | Individual firm, name withheld | Food | Class II | 1 |
| 3 Feb 2023 | Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251 | Avanos Medical, Inc. | Device | Class II | 1 |
| 3 Feb 2023 | ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311 | Instrumentation Laboratory | Device | Class II | 4 |
| 2 Feb 2023 | Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. UPN: M00500070 | Boston Scientific Corporation | Device | Class II | 1 |
| 2 Feb 2023 | ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 1 Feb 2023 | CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826 | Randox Laboratories | Device | Class II | 1 |
| 1 Feb 2023 | MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above | Quidel Corporation | Device | Class II | 1 |
| 28 Jan 2023 | SSS brand and K-Fresh branded Enoki Mushrooms Packaged in clear plastic 200g container (91721) | LLK TRADING INC | Food | Class I | 1 |
| 25 Jan 2023 | Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad) | Church & Dwight Inc | Device | Class II | 1 |
| 24 Jan 2023 | Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. | Outset Medical, Inc. | Device | Class II | 1 |
| 16 Jan 2023 | Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305 | Fujifilm Irvine Scientific, Inc. | Device | Class II | 1 |
| 14 Jan 2023 | Astor Chocolate Wafer Stick NWT WT. 11.64 OZ 330g UPC 72375102886 | Eastland Food Corporation | Food | Class II | 1 |
| 9 Jan 2023 | ISH Shrimpish Sample Meal Kit: ( Sample Meal Kit ) a package containing two ISH Foods plant-based Shrimpish products and several additional meal components. Each kit is shipped frozen, using styrofoam and dry ice. Affected components: ¿ Broth Plastic jar with lid ¿ XO Sauce Plastic Jar with lid ¿ Rice Mushroom Grits… (91485) | THE ISH COMPANY | Food | Class I | 1 |
| 3 Jan 2023 | Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE… | Western/Scott Fetzer Company | Device | Class II | 1 |
| 11 Nov 2022 | Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. | Abbott Molecular, Inc. | Device | Class II | 1 |
| 23 Sep 2022 | GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment. (91969) | GAGA PRO LIGHTING EQUIPMENT CO., | Device | Class II | 1 |
| 22 May 2022 | Peanut Butter Pie, 1 count (91875) | Desserts by Helen, Inc. | Food | Class I | 1 |
| 21 Oct 2021 | CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031 | Philips North America Llc | Device | Class II | 2 |