| 17 Jun 2019 | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07. Event 83093 | Name withheld | Drug | Class III | 1 |
| 13 Jun 2019 | Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20. | B. Braun Medical Inc | Drug | Class II | 1 |
| 13 Jun 2019 | Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64 | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 10 Jun 2019 | Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01 | Preferred Pharmaceuticals, Inc | Drug | Class II | 1 |
| 10 Jun 2019 | MONAKA BELGIUM CHOCO & KURUMI DAIICHI F, 2.68 oz. (76 g), Plastic wrapping Keep Frozen Product of Japan distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670 UPC 0 74410 71769 8 | Wismettac Asian Foods, INC | Food | Class II | 1 |
| 7 Jun 2019 | Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13 | Akorn Inc | Drug | Class III | 1 |
| 7 Jun 2019 | Bobbie Milk-Based Powder Companion Formula Net Wt. 14.1 oz. (400g) 22 servings per container Serving Size 4 scoops. Made in Germany Distributed by Bobbie Baby 520 Divisadero ST # 111 San Francisco, CA 94117 Event 83075 | Bobbie Baby inc | Food | Class I | 1 |
| 5 Jun 2019 | Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051. | P & L Developments, LLC | Drug | Class II | 3 |
| 5 Jun 2019 | Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 39131 0 | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 4 |
| 5 Jun 2019 | Basil Pesto, sold by weight in plastic deli containers PLU code beginning with 255926 | Whole Foods Market | Food | Class I | 2 |
| 4 Jun 2019 | Maglio Companies Jalapeno Peppers sold in the following sized packages: 10 lb. Qdoba Pepper; 1-1/9 BU Pepper, Jalapeno Select; 1-1/9 BU Pepper, Jalapeno; 10 lb. Pepper, Jalapeno Good Roots; 5 lb. Pepper, Jalapeno; 2 lb. Pepper, Jalapeno. Packed by The Fresh Group Ltd., Glendale, WI 53212. Event 83028 | The Fresh Group, Ltd. | Food | Class I | 1 |
| 4 Jun 2019 | Marine Harvest USA, Contains Fish: Atlantic Salmon, Premium 35 lbs, Product must be cooked before consumption. Non-ready to eat. Event 83042 | MOWI USA LLC | Food | Class II | 1 |
| 3 Jun 2019 | Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71 | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 31 May 2019 | ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12. | Chiesi USA, Inc. | Drug | Class II | 2 |
| 31 May 2019 | National Heartland Naturals Premium Quality Pearl Barley 32 oz Plastic Bag, UPC 707966600083 | Bedessee Imports, Inc | Food | Class II | 1 |
| 31 May 2019 | Izzio Artisan Bakery 100% Rye Bread, Net Weight: 9 oz ; 8 slices per package, Flow Wrap Package. Frozen. Item #3301, Case UPC #657082033015, Unit UPC #657082033015 | Izzio Artisan Bakery, LLC | Food | Class II | 1 |
| 30 May 2019 | Strawberry Banana Smoothie, 3.1oz, 6 pack, UPC Code 52159-70082 Event 82992 | Name withheld | Food | Class II | 1 |
| 28 May 2019 | Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free, Dye Free, Gluten Free, Cherry Raspberry Flavor, 16 Fl. oz. (474 mL), Manufactured in the USA for Kramer Novis, San Juan, PR 00917, www.kramernovis.com, NDC 52083-630-16. Event 82968 | Novis PR, Inc. | Drug | Class I | 1 |
| 28 May 2019 | Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. | Synthetopes Inc | Drug | Class II | 8 |
| 24 May 2019 | Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal,… | Cook Inc. | Device | Class I | 3 |
| 24 May 2019 | Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management | Teleflex Medical | Device | Class I | 8 |
| 24 May 2019 | Performance Mushrooms product is dried mushroom blend of 4 different mushroom mycelial biomass powders cultured on certified organic oats, brand Laird Superfood, uses as Beverage Booster and Functional Fuel Supplement. Product is packaged in 3.17 oz (90 gram) stand up with zipper, heat-sealed pouches. There are 6… Event 82954 | LAIRD SUPERFOOD INC | Food | Class III | 1 |
| 23 May 2019 | Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 23 May 2019 | Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846 | Pharm D Solutions, LLC | Drug | Class II | 18 |
| 22 May 2019 | GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x | GE Healthcare, LLC | Device | Class II | 1 |
| 22 May 2019 | Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20 | Fresenius Kabi USA, LLC | Drug | Class III | 1 |
| 22 May 2019 | 10.5 " Flat Edge Pizza Crust, packaged in a box with 40 pieces per box Event 82924 | Value Added Products | Food | Class II | 1 |
| 22 May 2019 | Bacon Shallot Potato Salad, internal item PLU code 52365, sold as bulk from the full service deli case per costumers order. The salad was packed into plastic deli containers. The label is read in parts: "*** Potatoes, red wine vinaigrette (Dijon mustard [water, mustard seeds, vinegar, salt], non-GMO canola oil, red… | New Seasons Market LLC | Food | Class I | 1 |
| 21 May 2019 | LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM, Model Number H41212ZD; e. Vscan Extend Sector… | GE Healthcare, LLC | Device | Class II | 1 |
| 21 May 2019 | PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31 | Heritage Pharmaceuticals, Inc. | Drug | Class I | 2 |
| 21 May 2019 | RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920. | Torrent Pharma Inc | Drug | Class II | 41 |
| 21 May 2019 | 7-Eleven The Italian Job refrigerated sandwich, clear plastic overwrap net wt. 9.7 oz. Event 82911 | Hearthside Food Solutions | Food | Class I | 1 |
| 21 May 2019 | Wegman's Neptune Salad 1 lb containers, UPC Begins with 2010883100000, Model/catalog # 13081 | Wegmans Food Markets, Inc. | Food | Class I | 1 |
| 20 May 2019 | Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 2 |
| 20 May 2019 | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310 | Teligent Pharma, Inc. | Drug | Class III | 1 |
| 20 May 2019 | Park Street Deli, Hummus and Veggies, Classic Hummus, Carrots & Celery NET WT 5 OZ (142g) | Del Monte Fresh Produce N.A., Inc. HQ | Food | Class II | 1 |
| 20 May 2019 | Suja Organic Kombucha - Ginger Lemon: 15.2 oz. glass bottle; UPC 818617020232 DISTRIBUTED BY SUJA LIFE, LLC OCEANSIDE, CA 92056 CERTIFIED ORGANIC BY CCOF SUJAJUICE.COM | Suja Life LLC | Food | Class II | 4 |
| 20 May 2019 | Pasteurized donor human breast milk, Pool 9029, Batch 1 packaged in 3 ounce (90 cc) plastic bottles | Mothers' Milk Bank at Austin | Food | Class I | 1 |
| 17 May 2019 | EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT | Covidien LLC | Device | Class II | 12 |
| 17 May 2019 | purely elizabeth Coconut Cashew Grain-Free Granola, packaged in Net Wt. 8 oz. (227g) Re-sealable Pouch, UPC 55140-00270, and Net Wt. 16 oz. (1LB) Re-sealable Pouch, UPC 55140-00294. Made with organic hemp, chia, and coconut flakes. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301. | Oakhouse Bakery | Food | Class II | 10 |
| 17 May 2019 | Laxmi Brand Dried Apricot 7 oz (200g) Plastic Pouch UPC Code: 2324617054 | House of Spices India, Inc. | Food | Class I | 1 |
| 17 May 2019 | Global Pride Rattan Shoots in Brine: 24 oz. glass jar UPC: 8855273023148 Erawan Enterprise Co. Ltd Bangkok, Thailand. Ingredients: Rattan 50.6%, Water 48.9%, Citric Acid (E330) 0.5% | U.S. Tov, Inc. | Food | Class I | 1 |
| 16 May 2019 | Cepheid Xpert C. difficile/Epi Control Panel | Microbiologics Inc | Device | Class III | 1 |
| 16 May 2019 | CHOCOLATE MILK CHOCOLATE MEIJI, 1.75 oz. Item number 70378 UPC 074410703783 - only on those bars with English labeling. Distributed by Wismettac Asian Foods, Inc. | Wismettac Asian Foods, INC | Food | Class II | 7 |
| 15 May 2019 | InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim” neurostimulators for… Event 82626 | Name withheld | Device | Class II | 1 |
| 15 May 2019 | Regal's Fundraising Cookies: Chocolate Chip flavor. Net Weight 12 oz. (340 grams). All varieties have the same ingredient list: Flour, Sugar, Cotton Seed Oil, Butter Blend, Chocolate Chips, Salted Butter, Vanilla Extract, Salt, Baking Soda. Regal Foods, Honolulu, HI www.regalfoodsusa.com | Regal Food Inc./dba The Pizza Shop | Food | Class II | 3 |
| 15 May 2019 | Cool Haus Awesome Dessert - Dairy Free Horchata Frozen Dessert Sandwich. Horchata Rice Milk & Cinnamon frozen dessert with Snickerdoodle Cookies 5.8 fl. oz. in film wrapper. 10 individual items per case. UPC: 851916003650 Product number: CoolV004 Ingredients: Snickerdoodle Cookies, enriched flour (wheat flour,… | COOLHAUS | Food | Class I | 1 |
| 15 May 2019 | Immuno PRP Spray, UPC 8 12527 01176 2. Colostrum Polypeptides. 5 fl oz (140 mL) | APS BioGroup, Inc | Food | Class II | 4 |
| 14 May 2019 | IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the… | Edwards Lifesciences, LLC | Device | Class I | 1 |
| 14 May 2019 | 365 by Whole Foods Market Classic Potato Salad packaged in a clear plastic clamshell 8 Oz. and a salad bar item UPC 81641602117 | Renaissance Food Group LLC | Food | Class I | 7 |
| 14 May 2019 | Art Cream Gluten Free Cookies & Cream ice cream, one pint. UPC 57897-00803. Products have been manufactured on Shared Equipment that Processes Peanuts, Tree Nuts, Milk, Wheat and Soybean Products. Event 82899 | Sassy Cow Creamery, LLC | Food | Class II | 1 |
| 10 May 2019 | CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during diagnostic cardiac… Event 82803 | Cardiocommand Inc. | Device | Class III | 1 |
| 10 May 2019 | QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102-1390 USA, NDC 47593-490-82 | Ecolab Inc | Drug | Class III | 1 |
| 9 May 2019 | Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed. Event 82796 | I.T.S. GmbH | Device | Class II | 1 |
| 9 May 2019 | Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21. | American Health Packaging | Drug | Class II | 1 |
| 9 May 2019 | Young Ocean brand Seasoned Alaskan Pollock Roe, frozen, wrapped in plastic liner and packed in styrofoam box, and finally packed in cardboard box. Net wt. per pack: 1 lb. Each cardboard box contains 20/1 lb. packs. The label is read in parts: "***Seasoned Alaskan Pollock Roe ***Ingredients: Pollock Roe, Salt,… Event 82855 | Young Ocean, Inc | Food | Class II | 1 |
| 6 May 2019 | Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications | NeuroLogica Corporation | Device | Class II | 1 |
| 6 May 2019 | GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 6 May 2019 | The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet. Event 82704 | Stiff Boy LLC | Drug | Class I | 1 |
| 6 May 2019 | ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06 | Zydus Pharmaceuticals USA Inc | Drug | Class II | 14 |
| 6 May 2019 | Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08 | Geritrex, LLC | Drug | Class II | 2 |
| 6 May 2019 | Biltmore, Sashimi Grade Smoked Wild Sockeye All Natural Alaskan Salmon, 4 oz. (113g) | Seven Seas International USA LLC | Food | Class I | 1 |
| 3 May 2019 | Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10. Event 82828 | Monarch Medical Technologies | Device | Class II | 1 |
| 3 May 2019 | AUTION HYBRID AU-4050 Event 82737 | Arkray Factory USA, Inc. | Device | Class II | 1 |
| 3 May 2019 | Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 3 May 2019 | Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, NDC 42852-001-27 | Avella of Deer Valley, Inc. Store 38 | Drug | Class II | 1 |
| 3 May 2019 | Gia Russa Whole Grain Italian Unseasoned Bread Crumbs in 10 Oz Paperboard Canisters | Icco Cheese Co Inc | Food | Class I | 2 |
| 2 May 2019 | Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT | Cook Inc. | Device | Class II | 1 |
| 2 May 2019 | Dole Classic Coleslaw (US) Shredded cabbage and carrots. 14 oz. US | Dole Fresh Vegetables | Food | Class II | 2 |
| 1 May 2019 | Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only Event 82746 | Name withheld | Device | Class II | 1 |
| 1 May 2019 | 30 Lbs IQF Wild Blueberries, Keep Frozen -10*C Event 82789 | Maine Wild Blueberry Company | Food | Class I | 1 |
| 1 May 2019 | First Street Dark Chocolate Nonpareils; 12 oz. stand up re-sealable plastic bags. Ingredients: Sweet Chocolate (sugar, chocolate liquor, cocoa butter, butter oil, soy lecithin, vanilla extract) seeds (sugar, cornstarch). Contains: milk, soy. Manufactured in a facility that processes peanuts, tree nuts, wheat and egg.… Event 82749 | Heritage Candy Company | Food | Class II | 1 |
| 30 Apr 2019 | Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1 | Stryker GmbH | Device | Class II | 2 |
| 30 Apr 2019 | Biscotti-Plain. Product is bulk packed in a master cardboard case and each master case contains either 48 or 36 individual biscotti. There are 12 Biscotti per layer and separated between layers with wax paper. Label applied to the exterior of master case only. The master case's label is read in parts: "***Paximadi… Event 82747 | Paximadi Co. LLC | Food | Class II | 1 |
| 30 Apr 2019 | Topnotch Foods Natural Bread Crumbs: 50 lb. Net Wt. 22.68 kg. and 10 lbs. 4.54 Kg. Item number 10021: Vernon, CA Correct Ingredients: Enriched, Bleached & Unbleached, Wheat Flour, [Flour, Malted Barley Flour, Niacin, Reduced Iron, Thiamine Mononitrate, Riboflavin, Folic Acid], Sugar, Yeast, Soybean Oil Contains 2% or… | Topnotch Foods Inc | Food | Class I | 2 |
| 29 Apr 2019 | Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the Information Center Software is to display… | Philips North America, LLC | Device | Class III | 2 |
| 29 Apr 2019 | Fiddyment Farms Fiddy Fire In-Shell Pistachios 2.5 oz., 8 oz., 1 lb., 2 lb., 3 lb., 5 lb., Fiddyment Farms Fiddy Fire Pistachio In Shell 25 lb.; Fiddyment Farms Fiddy Fire Gift Tin 6 oz.; Fiddyment Farms Gourmet Sampler 2.5 oz.; Fiddyment Farms Deluxe Pistachio Lovers Gift Box 6 oz., Fiddy Fire Gift Tin: 6 oz. Fiddy… Event 82742 | FIDDYMENT FARMS INC | Food | Class II | 1 |
| 26 Apr 2019 | ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps… | PF Consumer Healthcare 1 LLC | Device | Class II | 2 |
| 26 Apr 2019 | Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118,… | Cook Inc. | Device | Class II | 1 |
| 26 Apr 2019 | Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13… | Cytocell Ltd. | Device | Class III | 1 |
| 26 Apr 2019 | SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath Re-Collapsible Access System are sterile,… | Terumo Medical Corporation | Device | Class I | 3 |
| 26 Apr 2019 | Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30 | Exactech, Inc. | Device | Class II | 3 |
| 25 Apr 2019 | 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) | Mako Surgical Corporation | Device | Class II | 2 |
| 23 Apr 2019 | LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure… | CooperSurgical, Inc. | Device | Class II | 1 |
| 23 Apr 2019 | Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA | Arrow International Inc | Device | Class II | 36 |
| 22 Apr 2019 | ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in… | Inopak Ltd | Drug | Class II | 10 |
| 19 Apr 2019 | ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures | Ethicon, Inc. | Device | Class II | 2 |
| 18 Apr 2019 | Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain… | K2M, Inc | Device | Class II | 2 |
| 18 Apr 2019 | Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry | Skytron, Div. The KMW Group, Inc | Device | Class II | 1 |
| 18 Apr 2019 | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small | Zimmer Biomet, Inc. | Device | Class II | 6 |
| 18 Apr 2019 | Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus Long Sheath is indicated for the introduction of… Event 82755 | Name withheld | Device | Class II | 1 |
| 18 Apr 2019 | Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087 | Maquet Cardiovascular, LLC | Device | Class II | 183 |
| 17 Apr 2019 | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner… | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 5 |
| 16 Apr 2019 | Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado Foot Piece: Item Number: 00-1320-010-00 Alvarado Knee Holder Base Plate Assembly: Item Number: 00-1320-011-00 Alvarado II Foot Piece: Item Number: 00-1320-210-00 Alvarado II Base Plate: Item… | Zimmer Surgical Inc | Device | Class II | 1 |
| 15 Apr 2019 | Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using… | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 15 Apr 2019 | CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to… | Med Tec Inc | Device | Class II | 1 |
| 15 Apr 2019 | Ben & Jerry s Coconut Seven Layer Bar Bulk . The product is sold in a tub containing 2.4 gallons . | Unilever | Food | Class II | 2 |
| 12 Apr 2019 | OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation… | OMNIlife science Inc. | Device | Class II | 1 |
| 12 Apr 2019 | Colby Jack Cheese in 40 pound and 640 pound blocks Event 82633 | Hilmar Cheese Company, Inc. | Food | Class II | 1 |
| 11 Apr 2019 | NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis. | NxStage Medical, Inc. | Device | Class II | 2 |
| 9 Apr 2019 | Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand. | Microbiologics Inc | Device | Class II | 2 |
| 9 Apr 2019 | Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282 | Cook Inc. | Device | Class II | 4 |
| 9 Apr 2019 | Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135 Event 82594 | SELECT DISTRIBUTIONS LLC | Drug | Class I | 1 |
| 5 Apr 2019 | TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP) | Abbott Laboratories Inc. (St Jude Medical) | Device | Class II | 1 |
| 5 Apr 2019 | Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated… | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 3 Apr 2019 | 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility. | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class III | 1 |
| 1 Apr 2019 | RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0 | Teleflex Medical | Device | Class II | 5 |
| 1 Apr 2019 | Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 29 Mar 2019 | Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose conventional and digital R/F remote controlled system. | GE Healthcare, LLC | Device | Class II | 5 |
| 29 Mar 2019 | Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) | Conformis, Inc. | Device | Class II | 2 |
| 29 Mar 2019 | Sterile Nail Clipper Concave Edge (67710) | Centurion Medical Products Corporation | Device | Class II | 2 |
| 28 Mar 2019 | IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center… | Philips North America, LLC | Device | Class II | 4 |
| 25 Mar 2019 | Horizon Cardiology Hemo | Change Healthcare Israel Ltd. | Device | Class II | 2 |
| 22 Mar 2019 | TLS2 Thermal Ligating Shears, Catalog Number 132-131D | Microline Surgical, Inc. | Device | Class II | 1 |
| 21 Mar 2019 | Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. | Flowonix Medical Inc | Device | Class II | 5 |
| 11 Mar 2019 | Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053 | Randox Laboratories Ltd. | Device | Class II | 1 |
| 7 Mar 2019 | Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile. | Stryker Corporation | Device | Class II | 3 |
| 1 Mar 2019 | BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536 | Becton Dickinson & Company | Device | Class II | 1 |
| 22 Feb 2019 | xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316. Event 82745 | Luminex Molecular Diagnostics | Device | Class II | 1 |
| 12 Feb 2019 | Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. | GE Healthcare, LLC | Device | Class II | 6 |
| 11 Feb 2019 | Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 11 Feb 2019 | Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 4 Jan 2019 | King LTS-D Kit Size 1, Model Number KLTSD431 | King Systems Corp. dba Ambu, Inc. | Device | Class II | 1 |
| 13 Dec 2018 | R.H. Macy & Co. Milk Chocolate Covered Peanut Butter Pretzels, 8 oz 1 unit per package, oval metal tin canister, 6 units per case | Gertrude Hawk Brands dba Gertrude Hawk Chocolates | Food | Class II | 4 |
| 14 Nov 2018 | Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to restore the integrity of the spinal column… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 17 Oct 2018 | Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass. | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 13 Jul 2018 | Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical | Device | Class II | 1 |
| 8 Jun 2018 | MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. | Bio-Rad Laboratories, Inc | Device | Class II | 2 |
| 10 Apr 2018 | CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f)… | Accuray Incorporated | Device | Class II | 2 |
| 17 Jan 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F | OriGen Biomedical, Inc. | Device | Class I | 6 |