| 7 May 2021 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class III | 1 |
| 7 May 2021 | 21st Century Vitamin D3 125 mcg (5000 IU) tablet, 100 count, UPC 7-40985-27431-6, 21st Century HealthCare, Inc., 2119 Wilson St., Tempe, AZ 85282 Event 87951 | Twenty-First Century Healthcare, Inc | Food | Class II | 1 |
| 6 May 2021 | Waah Organic Rajma Masala Event 87885 | Agri Exim INC. | Food | Class II | 1 |
| 6 May 2021 | FANCY SEED PECAN HALVES 750 STERILIZED NET WT 30.00 Ingredients: Pecans Allergens: Pecans SOUTH GEORGIA PECAN Co. P.O.. Box 5366 Valdosta, GA 31603 800-627-6630 Event 87883 | South Georgia Pecan Company | Food | Class II | 1 |
| 6 May 2021 | Guan's Enoki Mushroom; Champignon d'enoki 100 g/3.5 oz. and 200 g/7 oz. packages. Clear package with blue band at bottom of front and back of package. UPC 100g: 859267007020; UPC 200g: 810023170303. Keep refrigeratedL Distributed by Guan's Mushroom, Los Angeles, CA | Forest Mushroom Food Inc. | Food | Class I | 1 |
| 6 May 2021 | Udi Gluten Free Banana Chocolate Chip Muffins, 10oz retail container of 4 muffins, 6 retail units per wholesale case. Retail unit UPC: 00-6-98997-81012-4 | CONAGRA BRANDS | Food | Class II | 4 |
| 5 May 2021 | Hershey s Chocolate Shell Topping plastic bottles in cases labelled Heath Shell Topping, 7.25 oz., 6 bottles per case Event 87880 | The Hershey Company | Food | Class I | 1 |
| 4 May 2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 4 May 2021 | Natural Way Almond Butter 16 oz. UPC 850001775175 packaged in clear plastic jars Event 87898 | Simkins Brothers Sweets, LLC dba Natural Way Food Group | Food | Class I | 1 |
| 4 May 2021 | "Bloomy*** Biotin Collagen Keratin***Capsules for SKIN, JOINT, HAIR***Supplement Facts***Marine Collagen***Manufactured for Bloommy Inc. 106 W. Broad St. Pawcatuck, CT 06379" Event 87858 | bloommy Inc. | Food | Class II | 1 |
| 4 May 2021 | Desserts On Us Original Traditional Baklava: Net Wt. 4 oz., (113g) UPC: 7 59098 51001 3 Desserts On Us, 57 Belle Falor Court, Arcata, CA 95521 Ingredients: Almonds, Sugar, filo dough [wheat flour(enriched with niacin, iron, thiamine mononitrate, riboflavin, folic acid) water, wheat protein isolate, salt, corn oil… | Desserts On Us, Inc. | Food | Class II | 2 |
| 3 May 2021 | Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25 | Pfizer Inc. | Drug | Class II | 1 |
| 3 May 2021 | Shrayy (white chalk) packaged in .68lb bags of synthetic plastic; no label on packaging Event 87845 | A LIFE AFRICAN MARKET CORP | Food | Class II | 1 |
| 29 Apr 2021 | Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 29 Apr 2021 | Veggie Pizza sold under the following brands: Crazy Fresh, quick & easy, and blank label. Item # 81068, Net Wt. 6.2 oz., UPC 7 95631 81068 4. Keep Refrigerated. Manufactured By: RDW St. Paul, MN 55121 | Russ Davis Wholesale Inc | Food | Class II | 1 |
| 29 Apr 2021 | Evolve Double Chocolate Plant-Based Protein Shake, 11oz "Tetra Pak" carton, sold 4 cartons per retail unit. UPC on retail 4 pack: 876063007887 Packed 3 retail four packs per wholesale case. | Pepsico Inc | Food | Class II | 2 |
| 28 Apr 2021 | Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1 | Preferred Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 28 Apr 2021 | NOW 4x6 Acidophilus, 60 capsules per retail bottle. Item number 2920. UPC 7 33739 02920 1 | NOW Health Group Inc. | Food | Class III | 1 |
| 27 Apr 2021 | Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03 | KVK-Tech, Inc. | Drug | Class III | 1 |
| 27 Apr 2021 | White Oak Farm & Table brand Pear Gorgonzola Salad Dressing & Dipping Sauce; 12 Fl OZ, packaged in glass bottles Event 87816 | Global Palate Foods | Food | Class II | 1 |
| 27 Apr 2021 | PUBLIC GOODS brand HAIR, SKIN, & NAILS Dietary Supplement; 60 tablets per bottle; Other ingredients: Stearic acid; croscarmellose sodium, magnesium stearate, aqueous film coating (purified water, hydroxypropyl methylcellulose, vegetable glycerin), microcrystalline cellulose. Allergens: Fish (gelatin from cod,… Event 87823 | Name withheld | Food | Class II | 1 |
| 27 Apr 2021 | Newly Weds A70088 bread crumbs X1, 35lbs bag | Newly Weds Foods Inc | Food | Class II | 22 |
| 26 Apr 2021 | Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a… | Teva Pharmaceuticals USA | Drug | Class II | 5 |
| 23 Apr 2021 | Thai Home brand Sweet Chili Paste (Num Prik Pao) packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004054 Manufactured by: Jansala & Foods LLC 1813 NE 2nd Avenue Portland, OR ansalafoods@gmail.com Distributed by: Earthly Gourmet 2143 SE Lafayette St Portland, OR 97202… Event 87805 | Jansala & Foods LLC | Food | Class III | 1 |
| 23 Apr 2021 | Velvet Buckeye Classic 16oz - 8 cartons to a case 56oz - 4 cartons to a case | Velvet Ice Cream Company | Food | Class I | 56 |
| 22 Apr 2021 | Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures. | Remel Inc | Device | Class II | 1 |
| 22 Apr 2021 | NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 | Abbott Laboratories Inc. (St Jude Medical) | Device | Class II | 1 |
| 22 Apr 2021 | Enoki Mushroom Product of Korea Net Wt. 200 g/7.05 oz. UPC: 809165 582015 Clear plastic bag with green band of color across the bottom of the bag, Golden Medal Mushroom Inc., 1811 Sacramento St., Los Angeles, CA 90021 Keep Refrigerated; Cook through before eating. | GOLDEN MEDAL MUSHROOM INC | Food | Class I | 1 |
| 22 Apr 2021 | Wolfie's Crunchy Cheddar & Jalapeno Peanuts Packaged in a Rice Paper Stand Up Pouch with Clear Poly Plastic Bag inside 5oz - 12 bags per case 14oz - 6 bags per case 28oz - 4 bags per case 80oz sold as individual bag Event 87775 | Wolfies Group Inc | Food | Class II | 1 |
| 21 Apr 2021 | ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4.0-6.0 mm and total… | Boston Scientific Corporation | Device | Class II | 1 |
| 21 Apr 2021 | Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01. Packaged in 150 cc white HDPE bottle | Heritage Pharmaceuticals Inc | Drug | Class III | 1 |
| 21 Apr 2021 | Caramel Rice Cakes 6.56oz (186g) 12 units per case 14 rice cakes per packaging Brands: Kroger Brand and Stop & Shop Brand Event 87801 | Basic Grain Products Inc | Food | Class I | 1 |
| 21 Apr 2021 | Jule's Cashew Brie (Classic) Net Wt. 6 oz. (1.70g) Keep Refrigerated. UPC 860388001507 | Jule's Foods | Food | Class I | 5 |
| 20 Apr 2021 | Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mechanism. Available with or without a titanium pyramid. The lanyard is part of the Alpha Interlock"… Event 87825 | WillowWood Global Llc | Device | Class II | 1 |
| 20 Apr 2021 | BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-38 | CareFusion 213, LLC | Drug | Class I | 1 |
| 20 Apr 2021 | Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05 | Genentech Inc | Drug | Class III | 1 |
| 20 Apr 2021 | S&W Organic Black Beans, 15 oz. can, Distributed by: Faribault Foods, 3401 Park Ave NW, Faribault, MN 55021. | Faribault Foods | Food | Class II | 3 |
| 20 Apr 2021 | Guan's Enoki Mushroom - Champigons d'enoki; Net Wt./ Poids Net 200 g/ 7.05 oz.; 25 individual packages per box. Distributed by Guan's Mushroom Co., Los Angeles, Ca 90040 Ingredients - 100% Fresh Enoki Mushroom - Keep Refrigerated. Product of China UPC 8 10023 17030 3 | Forest Mushroom Food Inc. | Food | Class I | 1 |
| 20 Apr 2021 | BTREX PLUS, Dietary Supplement 100 Caplets | Lopez Gonzalez Santana Corporation | Food | Class III | 1 |
| 19 Apr 2021 | Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10. | SigmaPharm Laboratories LLC | Drug | Class III | 2 |
| 19 Apr 2021 | vitafusion MultiVites 150ct, | Church & Dwight Co., Inc. OGI Distribution Center | Food | Class II | 6 |
| 19 Apr 2021 | Granny's Fudge Gorgeous Peanut Brittle, net wt. 5oz. or 8 oz, packed in a clear plastic container. No UPC. Label declares "***Ingredients: Sugar, peanuts, corn syrup, butter, vanilla, baking soda***Allergy Information: Mfg on same equipment that processes wheat, egg, peanut & tree nut. May contain traces of soy,… Event 87767 | JKH Enterprises | Food | Class II | 1 |
| 19 Apr 2021 | SCB 12" Chocolate Chip Cookie Cake In CPET Tray with lid. Keep Frozen 0 Degrees F. Net Wt. 36.00 lbs. (16.33 kg) Case count: 25 Item # 167557 Allergen Warning: Contains: Egg, Milk, Soy, Wheat Do no consume raw. Bake time and temP Oven 330F x 12-16 minutes Event 87757 | South Coast Baking Co. | Food | Class II | 1 |
| 16 Apr 2021 | Bueno Coffee Substitute Creamy Hazelnut, Gluten-Free, net wt. 7 oz. (200g), UPC 6 79345 10020 3. INGREDIENTS: Garbanzo Beans (Chickpeas) and Natural Hazelnut Flavoring. Manufactured By: Creative Foods, Inc. Prineville, Oregon. Bueno Coffee Substitute Creamy Hazelnut, Gluten-Free, net wt. 3 lbs. (1360g), UPC 6 79345… | Creative Foods Inc | Food | Class I | 2 |
| 16 Apr 2021 | Driscoll's Fresh Blackberries; 6 oz. or 18 oz. containers. | Driscoll's Inc. | Food | Class III | 1 |
| 15 Apr 2021 | Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210 | Boston Scientific Corporation | Device | Class II | 2 |
| 15 Apr 2021 | Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope. | Haag-Streit USA Inc | Device | Class II | 1 |
| 15 Apr 2021 | Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfport, MS 39501 228-863-3331 Event 87742 | Grace Healthcare Medical, Inc | Drug | Class II | 1 |
| 14 Apr 2021 | Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451 Event 87809 | Fresenius Medical Care, North America | Drug | Class II | 1 |
| 14 Apr 2021 | Raley's Salt & Vinegar Flavored Potato Chips 9.5oz flexible plastic packaging 11 bags per case | Shearer'S Snacks | Food | Class II | 1 |
| 14 Apr 2021 | Organic Mr. Goodtime Bunny***NET WT 3.35 LBS (1.4kg)***INGREDIENTS: *Milk, *Dark, AND *WHITE CHOCOLATE (*SUGAR, *MILK POWDER, *COCOA BUTTER, *CHOCOLATE LIQUOR, *COCOA POWDER (PROCESSED WITH ALKALI), *SOYBEAN LECITHIN, *VANILLA EXTRACT, AND *VANILLA POWDER). CONTAINS MILK AND SOYBEAN. MAY CONTAIN TRACES OF PEANUTS,… | Champlain Chocolate Company | Food | Class II | 2 |
| 14 Apr 2021 | Jose Madrid Salsa - Strawberry Mild Salsa 13oz glass jars, 12 jars per case | Michael Zakany LLC | Food | Class II | 1 |
| 14 Apr 2021 | Panera Lobster Bisque, 16 oz. | Blount Fine Foods Corporation | Food | Class II | 1 |
| 14 Apr 2021 | Blanched Penne Rigati 8oz plastic bag 40 bags per case Event 87736 | T MARZETTI INNOVATION CENTER | Food | Class I | 1 |
| 13 Apr 2021 | Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15 | Nomax Inc | Drug | Class III | 1 |
| 13 Apr 2021 | Dark Chocolate Expresso Beans; Net Wt. 12 oz. (340g), Best if used by 11-19-2021. Contains Soy, May Contain Milk. Packed in a facility that processes on share equipment with Peanuts, Tree Nuts, Milk, Wheat and Egg. UPC: 0 72488 99868 1 Packed by Torn & Glasser, Los Angeles, CA | Torn & Glasser, Inc. | Food | Class II | 1 |
| 12 Apr 2021 | VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature. | Boston Scientific Corporation | Device | Class I | 2 |
| 12 Apr 2021 | DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck. | DJ Orthopedics de Mexico S.A. de C.V. | Device | Class II | 4 |
| 12 Apr 2021 | Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharmaceuticals, Inc., Mfg: Ascend Laboratories, LLC, NDC #: 68788-7529-1, | Preferred Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 12 Apr 2021 | Ample Hills Creamery Chocolate Milk and Cookies Ice Cream, 14 oz. Event 87707 | Ample Hills Manufacturing LLC. | Food | Class II | 1 |
| 12 Apr 2021 | G4G Low Carb Pancake & Waffle Mix, Keto Friendly Just Add Water Net Wt 12 ounces, 6pack Case UPC 860000241427 packaged in a rigid cardboard box Event 87744 | Backcountry Mills LLC | Food | Class II | 1 |
| 12 Apr 2021 | Love & Peas Protein Rich Meal Replacement, 1 LB 8 OZ (675 G) bag, Nature's Sunshine Products, Inc., Spanish Fork, Utah, 84660 (800) 223-8225, naturessunshine.com, UPC 0 99904 03082 4 | NATURE'S SUNSHINE PRODUCTS | Food | Class I | 2 |
| 12 Apr 2021 | Botanic Choice Green Tea Leaf Extract (3:1 Extract), Alcohol Free Liquid Extract, 1 FLOZ., in glass jar with dropper, UPC 703308200164 Event 87702 | Indiana Botanic Gardens, Inc | Food | Class III | 1 |
| 10 Apr 2021 | Hostesss SnoBalls packaged as Hostess Chocolate CupCakes, Net Wt 3.17 OZ, UPC 8 88109 01001 0, Hostess Brands, LLC Kansas City, MO | HOSTESS BRANDS LLC | Food | Class II | 1 |
| 9 Apr 2021 | Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 | Medical Action Industries, Inc. 306 | Device | Class I | 6 |
| 8 Apr 2021 | CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208 | Smith & Nephew, Inc. | Device | Class II | 1 |
| 8 Apr 2021 | Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19 | Meridian Bioscience Inc | Device | Class II | 2 |
| 8 Apr 2021 | Natrol Melatonin 3 mg, Tab 60 White bottle with purple flip-top cap. Fall asleep faster, Stay asleep longer, 100$ Drug Free 1 Tablet 20 minutes before bedtime. Manufactured by Natrol LLC. Chatsworth, CA 91311 USA Event 87704 | Natrol, LLC | Food | Class II | 1 |
| 7 Apr 2021 | Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and… | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 1 |
| 7 Apr 2021 | RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 7 Apr 2021 | Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. | Roche Diagnostics Operations, Inc. | Device | Class II | 2 |
| 7 Apr 2021 | REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use when central venous catheterization is prescribed. | Bard Access Systems Inc. | Device | Class II | 18 |
| 6 Apr 2021 | LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00. | LeMaitre Vascular, Inc. | Device | Class II | 1 |
| 6 Apr 2021 | CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED). | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 2 |
| 6 Apr 2021 | Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureScan, Azure XT SR MRI SureScan, Azure S SR… | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 4 |
| 6 Apr 2021 | PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ | Hyobin LLC | Drug | Class II | 3 |
| 6 Apr 2021 | Signature Select Golden Corn Sweet, frozen, packed in poly film bags. 12/16 oz. packages per case. UPC 2113009152. Signature Select Golden Corn Sweet, frozen, packed in poly film bags, 12/32 oz. packages per case. UPC 2113009021. Product of USA. Products is DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99… | Twin City Foods, Inc. | Food | Class II | 1 |
| 5 Apr 2021 | GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree. | W.L. Gore & Associates, Inc. | Device | Class II | 1 |
| 5 Apr 2021 | MRE LITE Animal Based Protein, Oatmeal Chocolate Chip, Animal Protein Powder Drink Mix, Net Wt. 30.69 oz (1.92lb) (870g) Event 87690 | REDCON1 LLC | Food | Class II | 1 |
| 3 Apr 2021 | ISOMORPH 28 PURE WHEY iSOLATE BANANA CREAM PIE DIETARY SUPPLEMENT NET WT. 2lb, UPC 6 49241 89846 7 & 5LB, UPC 6 49241 87829 2 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071 | Hi Tech Pharmaceuticals | Food | Class I | 14 |
| 1 Apr 2021 | Power Wheelchair | Merits Holdings Co. dba Merits Health Products, Inc. | Device | Class II | 2 |
| 31 Mar 2021 | Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree. | Smiths Medical ASD Inc. | Device | Class II | 2 |
| 31 Mar 2021 | IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702 | QMart | Drug | Class II | 4 |
| 30 Mar 2021 | Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 30 Mar 2021 | Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Model: 32.Z2000.00,… Event 87680 | Omnia SRL | Device | Class II | 1 |
| 30 Mar 2021 | PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006 | Na Na Collection | Drug | Class II | 2 |
| 29 Mar 2021 | Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351 | Randox Laboratories Ltd. | Device | Class II | 1 |
| 29 Mar 2021 | Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma. Event 87635 | Atos Medical AB | Device | Class II | 1 |
| 29 Mar 2021 | VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing. | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 29 Mar 2021 | Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper Flex Cardio 2010 Rev B 453564483321 Flex… | Philips North America Llc | Device | Class II | 1 |
| 29 Mar 2021 | AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007 | Musculoskeletal Transplant Foundation, Inc. | Device | Class II | 1 |
| 29 Mar 2021 | Tuscan Garden Ranch Dressing, packaged in 16 oz bottles, Dist. & Sold Exclusively by ALDI, Batavia, IL packaged in 12 bottles per case Event 87634 | Richelieu Foods, Inc. | Food | Class II | 1 |
| 26 Mar 2021 | VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure. | Ortho-Clinical Diagnostics, INc. | Device | Class II | 1 |
| 26 Mar 2021 | InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis. | Nextremity Solutions | Device | Class II | 2 |
| 26 Mar 2021 | Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 26 Mar 2021 | INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction. The procedural kits have no kit specific labeling. Each product within the kits has its own product specific… | ConMed Corporation | Device | Class II | 2 |
| 26 Mar 2021 | Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part Event 87657 | Name withheld | Device | Class I | 1 |
| 26 Mar 2021 | Regard Dressing Change Tray | ROi CPS LLC | Device | Class II | 1 |
| 26 Mar 2021 | Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3. Event 87627 | Antoto-K | Drug | Class II | 1 |
| 25 Mar 2021 | Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: “ Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator “ Intellis Model 97716 Implanted Neurostimulator. Event 87674 | Name withheld | Device | Class II | 1 |
| 25 Mar 2021 | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood… | Bard Peripheral Vascular Inc | Device | Class II | 3 |
| 25 Mar 2021 | PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4 Event 87609 | Namoo Enterprise LLC | Drug | Class II | 1 |
| 25 Mar 2021 | Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5 Event 87613 | S & B Story LLC | Drug | Class II | 1 |
| 24 Mar 2021 | Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules. Event 87630 | Bit & Bet LLC | Drug | Class II | 1 |
| 23 Mar 2021 | Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157 | Bioseal Corporation | Device | Class II | 3 |
| 23 Mar 2021 | VenaSeal Closure System | Medtronic Inc. | Device | Class III | 1 |
| 22 Mar 2021 | BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system | Name withheld | Device | Class II | 19 |
| 22 Mar 2021 | Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53,… | Datascope Corp. | Device | Class III | 2 |
| 19 Mar 2021 | Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 19 Mar 2021 | Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481 | Cytocell Ltd. | Device | Class II | 1 |
| 19 Mar 2021 | Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. | GE Healthcare, LLC | Device | Class II | 1 |
| 19 Mar 2021 | Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 19 Mar 2021 | Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr) | Cardiac Assist, Inc | Device | Class II | 1 |
| 19 Mar 2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400 | CareFusion 213, LLC | Drug | Class I | 8 |
| 18 Mar 2021 | VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology. | Luminex Corporation | Device | Class II | 1 |
| 18 Mar 2021 | Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741 | Coltene Whaledent Inc | Device | Class II | 1 |
| 18 Mar 2021 | AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3 units make up the AquaBplus 2500Fresenius… | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 17 Mar 2021 | Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection. Event 87637 | Clark Laboratories, Inc. | Device | Class II | 1 |
| 17 Mar 2021 | Change Healthcare Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY | Device | Class II | 1 |
| 16 Mar 2021 | EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430 | Boston Scientific Corporation | Device | Class III | 1 |
| 16 Mar 2021 | Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. | Medtronic Inc. | Device | Class II | 1 |
| 16 Mar 2021 | REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications. | ICU Medical, Inc. | Device | Class II | 26 |
| 15 Mar 2021 | Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. | B. Braun Medical, Inc. | Device | Class II | 1 |
| 15 Mar 2021 | ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing. | St. Jude Medical, Cardian Rhythm Management Division | Device | Class I | 2 |
| 10 Mar 2021 | heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL) bottle, Heal The World, LLC, Draper, UT 84020, UPC 6 19988 44038 0. Event 87531 | PNHC, LLC. | Drug | Class I | 1 |
| 2 Mar 2021 | Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152; Packaged Exclusively By: A-S Medication Solutions LLC, Libertyville, IL 60048, Product # 6967-0; NDC: 50090-5350-0; contained within Health Essentials Kit, Kit Contains: 1 bottle hand… | A-S Medication Solutions LLC. | Drug | Class I | 1 |
| 26 Feb 2021 | Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part Event 87773 | STEP-HAR MEDICAL LLC | Device | Class I | 1 |
| 26 Feb 2021 | Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to… | Medtronic Inc. | Device | Class II | 20 |
| 22 Feb 2021 | RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 7 Feb 2021 | NM/CT 850 Nuclear Medicine / CT Scanners | GE Healthcare, LLC | Device | Class II | 3 |
| 5 Feb 2021 | DJO EMPOWR KNEE Femoral Sizer | Encore Medical, LP | Device | Class II | 1 |
| 2 Feb 2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15 | Teligent Pharma, Inc. | Drug | Class III | 3 |
| 31 Jan 2021 | Kewpie Deep Roasted Sesame Dressing; 8 oz.(263ml/243g) and 64 oz. (1893 ml/1950g) bottles (glass and plastic) Refrigerate after opening. UPC 8 oz: 8 719189 240153 UPC 64 oz. 8 719189 24160 Manufactured by Q&B Foods Inc. 15547 First St., Irwindale, CA 91706 Event 87798 | KEWPIE TRADING EUROPE B.V. | Food | Class II | 1 |
| 7 Dec 2020 | Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use. | Oto Med Inc | Device | Class II | 3 |
| 2 Dec 2020 | Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump. Event 87551 | Medela AG Medical Technology | Device | Class II | 1 |
| 13 Jul 2020 | BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples) | Lopez Gonzalez Santana Corporation | Food | Class III | 2 |
| 28 Feb 2020 | ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions. Event 87818 | Argo Medical Technologies Ltd | Device | Class II | 1 |
| 8 Mar 2019 | Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90 | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 1 |