| 13 May 2019 | Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60 | MALLINCKRODT PHARMACEUTICALS | Drug | Class II | 2 |
| 11 May 2019 | Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61. | Novartis Pharmaceuticals Corp. | Drug | Class I | 1 |
| 9 May 2019 | Deshi Golden Raisin, packaged in 3.5 oz, 7 oz. and 14 oz. clear plastic Event 82831 | DESHI DISTRIBUTORS, LLC | Food | Class I | 1 |
| 7 May 2019 | Mecox Bay Dairy Sunrise Raw Milk Cheese in plastic wrap code L 2148 Size Range between .25 lb to 3 lb portions of a 3 lb wheel. Event 82798 | Mecox Bay Dairy | Food | Class I | 1 |
| 7 May 2019 | Signature Kitchens Green Peas & Diced Carrots; Net Wt 16 oz (1 lb) 453 g; UPC 2113009154; frozen | Twin City Foods Inc. | Food | Class II | 1 |
| 6 May 2019 | Item FG 10037, Barlean s Cod Liver Oil Omega 3 EPA/DHA with Added Vitamin D, 100 softgel per bottle. UPC 7 05875 61010 0 | Barlean's Llc | Food | Class III | 12 |
| 3 May 2019 | Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.… | Heritage Pharmaceuticals, Inc. | Drug | Class II | 5 |
| 3 May 2019 | Back Roads Granola: Ancient Grains Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb | Back Roads Food Company | Food | Class II | 9 |
| 2 May 2019 | OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable… | Oakworks Inc | Device | Class II | 1 |
| 2 May 2019 | Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116 Event 82760 | Septodont Inc. | Drug | Class II | 1 |
| 2 May 2019 | CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891 | Unipharma, Llc. | Drug | Class II | 11 |
| 2 May 2019 | Life Rising Holder-W Holder Warmer capsules, 54 count bottle | Life Rising Corporation | Food | Class I | 3 |
| 1 May 2019 | Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated | Golden State Medical Supply Inc. | Drug | Class II | 5 |
| 1 May 2019 | Dragonfly Dehydrate Guava Ing: Guava, Sugar, Salt Net Wt: 5.25 ozs 150g Distributed by: U.S. Trading Company Product of Thailand Item Number:37115 UPC: 721557371152 | U.S. Tov, Inc. | Food | Class III | 1 |
| 30 Apr 2019 | Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044 | Par Pharmaceutical, Inc. | Drug | Class I | 1 |
| 30 Apr 2019 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02 | Sagent Pharmaceuticals Inc | Drug | Class II | 1 |
| 30 Apr 2019 | Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ | Preferred Pharmaceuticals, Inc | Drug | Class II | 1 |
| 29 Apr 2019 | DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental… Event 82694 | KaVo Dental Technologies LLC | Device | Class II | 1 |
| 29 Apr 2019 | Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017. | Pfizer Inc. | Drug | Class III | 1 |
| 26 Apr 2019 | HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10 | Advanced Pharma Inc. | Drug | Class II | 1 |
| 26 Apr 2019 | Dried whole elderberry, Oregon s Wild Harvest brand, packaged in metalized plastic bag, net wt. 4 oz or 1 lb. Each case contains 12 bags. Item # for 4 oz. is 15352. UPC of 4 oz. bag is 7 06195 05352 3. Item # for 1 lb. is 11352. UPC of 1 lb. bag is 7 06195 01352 7. The label is read in part: "***Elderberry Whole ***… Event 82717 | Oregons Wild Harvest Inc | Food | Class II | 1 |
| 26 Apr 2019 | Dangonds Arepas de Queso, Net Weight 1,400g Event 82731 | Dangonds Foods LLC | Food | Class II | 1 |
| 25 Apr 2019 | Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67 Event 82660 | US Worldmeds LLC | Drug | Class II | 1 |
| 25 Apr 2019 | Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6 | Advantice Health | Drug | Class III | 2 |
| 25 Apr 2019 | Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01 | Zydus Pharmaceuticals USA Inc | Drug | Class II | 2 |
| 24 Apr 2019 | Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478 | AVKARE Inc. | Drug | Class II | 2 |
| 24 Apr 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54 | Legacy Pharmaceutical Packaging LLC | Drug | Class II | 1 |
| 24 Apr 2019 | Wegmans Food You Feel Good About Cilantro Lime Green Sauce. A finishing sauce for meats, seafood & Veggies in 8 oz. plastic containers or .5 gallon bulk plastic containers. | Wegmans Food Markets, Inc. | Food | Class II | 1 |
| 24 Apr 2019 | Fresh Cooked Pink Shrimp Meat, refrigerated, packaged in 5 pound plastic tubs with a label sticker on the lid. Master carton is cardboard Bornstein Box. The label is read in parts: "***WILD OREGON FRESH COOKED Shrimp Meat ***KEEP REFRIGERATED*** NET WT 5 lb ***Ingredients: Shrimp meat with salt added ***PACKED BY… | Bornstein Seafoods Inc | Food | Class II | 1 |
| 24 Apr 2019 | Parsley flakes, Petroselinum sativum, 1# Net, AmeriHerb LLC, Ames, IA packaged in 1 lb plastic bags | AmeriHerb International Inc | Food | Class II | 6 |
| 23 Apr 2019 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25 | Akorn Inc | Drug | Class III | 1 |
| 23 Apr 2019 | Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020 Event 82758 | D.B.P. Distribution | Drug | Class I | 1 |
| 23 Apr 2019 | Haikui Abalone in Brown Sauce 3 oz pouch bag,UPC Code: 719926149198 Event 82707 | Name withheld | Food | Class III | 1 |
| 23 Apr 2019 | Harmless Harvest Dairy-Free Yogurt Drink; Cultured Coconut Drink; Probiotic Original Unsweetened. 8 fl. oz. plastic bottle; UPC 859078-002962 USDA Organic | Harmless Harvest Inc. | Food | Class II | 4 |
| 22 Apr 2019 | Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G14837; 8.0 Fr 003800 G14844; Set with AQ Hydrophilic Coating PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr AQ-003500 G17150; 6.0 Fr AQ-003600 G17151; 7.0 Fr AQ-003700 G17152 | Cook Inc. | Device | Class II | 2 |
| 22 Apr 2019 | Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00. | RemedyRepack Inc. | Drug | Class II | 1 |
| 22 Apr 2019 | Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05 | Zydus Pharmaceuticals USA Inc | Drug | Class III | 1 |
| 22 Apr 2019 | Key Lime and Cream Torte, 5 oz., Keep in Freezer for up to 6 months or refrigerated for 5 days Event 82678 | Island Desserts Llc DBA Pastry Art | Food | Class II | 1 |
| 22 Apr 2019 | Blue cheese & toasted walnut garlic balsamic vinaigrette, packaged in 6.3-fl. oz. glass bottle. The label is read in parts: "***Ingredients: balsamic vinegar, extra virgin olive oil, roasted walnuts, blue cheese crumbles, salt, pepper***giannisfinefoods.com***". Event 82679 | Gianni's Fine Food | Food | Class II | 1 |
| 19 Apr 2019 | SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). | Philips North America, LLC | Device | Class II | 8 |
| 19 Apr 2019 | FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47. | Alvogen, Inc | Drug | Class I | 1 |
| 19 Apr 2019 | BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 Lot:190212AB BUD:5/13/2019, Repackaged on 2/12/2019 | Pacifico National, Inc. dba AmEx Pharmacy | Drug | Class II | 1 |
| 19 Apr 2019 | Item #13898 Raw California Orange Blossom Honey, packaged in an 18 oz jar with gold metal lid. Retail Jar UPC: 0 30042 00305 9. Item #13899 Raw California Orange Blossom Honey packaged in a case with 6 / 18 oz jars with gold metal lids. Case UPC: 0 30042 00338 7. The label is read in parts: "*** Raw Honey California… Event 82681 | Glorybee Natural Sweeteners, Inc. | Food | Class III | 1 |
| 18 Apr 2019 | Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 18 Apr 2019 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | Torrent Pharma Inc. | Drug | Class II | 6 |
| 17 Apr 2019 | Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes | Remel Inc | Device | Class II | 4 |
| 17 Apr 2019 | Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes | Remel Inc | Device | Class II | 10 |
| 17 Apr 2019 | Healthy Life Snacks- Tropical Trail Mix 4 oz Polypropylene bag UPC code 2362918909 Event 82713 | Healthy Life Snacks, Inc. | Food | Class II | 1 |
| 16 Apr 2019 | Banana Puddin Base, item # 70 0559-1034, in 5 gallon plastic pail. Net Wt: 48 LBS. Ice Cream Flavoring. Store Refrigerated (35-45F) at all times. Denali Ingredients LLC, 2400 S. Calhoun Rd, New Berlin, WI 53151 Event 82649 | Denali Ingredients LLC | Food | Class I | 1 |
| 15 Apr 2019 | Le Cafe de la Plage Malibu Black Vanilla; Hand-Crafted Ice Cream 1 Pint PETE plastic twist top container: Event 82658 | LE CAFE DE LA PLAGE | Food | Class II | 1 |
| 15 Apr 2019 | Frozen ground tuna, 1 lb package, 20 packages/case Event 82628 | Jensen Tuna Inc | Food | Class I | 1 |
| 15 Apr 2019 | All Juice Drinks and Beverages in 12 ounce glass bottles including but not limited to Agony, Double Trouble, Front End Lifter, Irish (sea) Moss, Cashew Punch, Carrot Juice, Sorrel, Carrots & Beet, Carrot & Ginger, Ginger Beer, Pineapple Twist. Keep Refrigerated Event 82631 | Juices International, Inc. | Food | Class II | 1 |
| 14 Apr 2019 | Shredded and blocks of Colby & Monterey Jack cheese - Labeled and Packaged: 1) Great Value, Finely Shredded, Colby & Monterey Jack Cheese, Net Wt 8 oz; packaged in plastic pouches, 12 per case; 2) Great Value, Finely Shredded, Colby & Monterey Jack Cheese, Net Wt 16 oz; packaged in plastic pouches, 10 per case; 3)… | Schreiber Foods Inc | Food | Class II | 2 |
| 13 Apr 2019 | Chewy Chips Ahoy Cookie (13 OZ) | Mondelez Global Llc | Food | Class II | 1 |
| 12 Apr 2019 | Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | CMC Enterprise Pharmacy | Drug | Class II | 32 |
| 12 Apr 2019 | Fresh cut watermelon, fresh cut honeydew melon, fresh cut cantaloupe and fresh cut mixed fruit containing one of these melons. | Caito Foods LLC. | Food | Class I | 1 |
| 12 Apr 2019 | Wawa Iced Tea Less Sugar, Net weight/number of units per package: 12 FL OZ. , Package type: Bottle Units per case: 24, Expiration date: April 29, 2019 (APR/29/19) Event 82643 | Wawa, Inc. | Food | Class III | 1 |
| 11 Apr 2019 | Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the… | Ethicon Endo-Surgery Inc | Device | Class I | 12 |
| 11 Apr 2019 | Patagonia Provisions Classic Barbecue Savory Seeds; 1 oz. poly-film pouches. 12 units per case Vegan, Gluten Free Distributed by Patagonia Provisions, Inc. Sausalito, CA | Patagonia Provisions Inc | Food | Class II | 4 |
| 10 Apr 2019 | Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01 | Name withheld | Drug | Class III | 5 |
| 10 Apr 2019 | Trader Joe's Saucy Scallops with Mushrooms, NET Wt. 16 oz. (1 LB) 454 g UPC 0093 0390 24 units per case Product of France Dist. and sold exclusively by: Trader Joe's Monrovia, CA 91016 Event 82634 | Frial SAS | Food | Class II | 1 |
| 10 Apr 2019 | Lamb s Supreme Potato Tater Puffs, item # H30, packaged in 5-pound unprinted KRAFT paper bags, 6 bags to a case, sold as a foodservice item. UPC 1 00 44979 00830 5. The case label is read in parts: "***LAMB'S SUPREME TATER PUFFS***FROZEN POTATOES***6/5 LB BAGS***Produced by Lamb Weston, 8701 W. Gage Blvd. Kennewick,… Event 82622 | Lamb Weston BSW LLC | Food | Class II | 1 |
| 10 Apr 2019 | Formagere de la Brie FORMAGE FRANCAIS l'Explorateur, packaged in a plastic container, in 100g, 250g - UPC: 3 390010004080, and 1kg packages. | Societe Fromagere de la Brie | Food | Class I | 2 |
| 9 Apr 2019 | ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood. | Abbott Laboratories | Device | Class III | 9 |
| 9 Apr 2019 | Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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. Procedures that can be performed… | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 9 Apr 2019 | Mediterranean Brands Callaloo Greens, Product 6017. Net Weight 15.0 lbs (6.90 Kgs). Keep Frozen. Manufactured for: MBI, Glenview, IL 60025 Event 82606 | American Pasteurization Company, LLC | Food | Class II | 1 |
| 9 Apr 2019 | Deli Cut Ham and American Sandwich 5.5 OZ. | Great American Marketing Company | Food | Class I | 8 |
| 8 Apr 2019 | Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C) | DePuy Spine, Inc. | Device | Class II | 2 |
| 8 Apr 2019 | AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation,… | Boston Scientific Corporation | Device | Class II | 9 |
| 8 Apr 2019 | MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole Mount System MoniTorr 10140 10-140 CSF Drainage System w/Vinyl Measuring Strip MoniTorr 10150 10-150 CSF Drainage… | Integra LifeSciences Corp. | Device | Class I | 3 |
| 8 Apr 2019 | Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106 | Zimmer GmbH | Device | Class II | 76 |
| 8 Apr 2019 | MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S | Compass Health Brands (Corporate Office) | Device | Class II | 6 |
| 8 Apr 2019 | GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21 | American Health Packaging | Drug | Class II | 1 |
| 8 Apr 2019 | BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272 | Name withheld | Drug | Class II | 10 |
| 8 Apr 2019 | Frozen Poppy Seed Bread (57 grams), UPC Codes: (01)03556420003673(15)191122(10)181122(91)0937326, Lot 22112018 Event 82591 | Laduree Usa | Food | Class II | 1 |
| 8 Apr 2019 | Goji Powder (aka Wolfberry Powder) Event 82735 | Xi'an Yuensun Biological Technology Co., Ltd. | Food | Class III | 1 |
| 5 Apr 2019 | Cashew Brittle Bits in clear 4oz bag with a Best By date of 07/14/19 and barcode number of 00369 Event 82603 | Hercules Candy Company | Food | Class I | 1 |
| 3 Apr 2019 | Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.… | Elekta Limited | Device | Class II | 1 |
| 3 Apr 2019 | Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically. Event 82675 | Thommen Medical AG | Device | Class II | 1 |
| 3 Apr 2019 | G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes | Randox Laboratories Ltd. | Device | Class II | 2 |
| 3 Apr 2019 | BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066 | Becton Dickinson & Co. | Device | Class II | 2 |
| 1 Apr 2019 | Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use fiber K2011828 400 micron 5X reusable fiber… Event 82625 | Dornier Medtech America, Inc. | Device | Class II | 1 |
| 31 Mar 2019 | Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial… | Integra Limited | Device | Class II | 1 |
| 28 Mar 2019 | Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair) | R82 A/S | Device | Class II | 1 |
| 28 Mar 2019 | T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges,… | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 28 Mar 2019 | Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for palliation of… | Edwards Lifesciences, LLC | Device | Class I | 2 |
| 28 Mar 2019 | Yellow Corn Flour #620, Unenriched, packaged in bulk and 50 lb bags | Name withheld | Food | Class II | 2 |
| 28 Mar 2019 | Samira Food Products Vegeterian 100% Soy Chunk, Net Wt. 8oz Event 82500 | Traders West Inc | Food | Class II | 1 |
| 27 Mar 2019 | ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0 | CooperSurgical, Inc. | Device | Class II | 1 |
| 27 Mar 2019 | Lee's Tea brand of Pink Chai - Organic Spiced Tulsi Tea Blend Loose Leaf Tea packaged in re-sealable plastic pouches sizes 30g, UPC 6 28055 21014 6 and 90g, UPC 6 28055 21004 7. Event 82711 | LEE'S PROVISIONS INC | Food | Class II | 1 |
| 26 Mar 2019 | EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number:… | Molnlycke Health Care, Inc | Device | Class II | 1 |
| 26 Mar 2019 | Stanganellis Italian Foods, Pumpkin Cake Roll, Net Wt. 24 oz. . One pie per package . Box. Event 82508 | Spagel Brothers, Inc. | Food | Class II | 1 |
| 25 Mar 2019 | Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device | Philips Medical Systems Nederlands | Device | Class II | 1 |
| 25 Mar 2019 | Rice Valley Ready Cooked Noodles and Instant Noodles, Net Wt, 14 oz. plastic bag - Perishable, Keep Refrigerate UPC 9 92320 40305 3, UPC: 9 9230 40301 5 Made in USA Rice Valley Foods Company, San Francisco, CA 94124 Event 82486 | Rice Valley | Food | Class II | 1 |
| 22 Mar 2019 | Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 22 Mar 2019 | ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills | Cardinal Health 200, LLC | Device | Class II | 4 |
| 21 Mar 2019 | EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor). | Edwards Lifesciences, LLC | Device | Class I | 1 |
| 21 Mar 2019 | ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery. | Conmed Corporation | Device | Class II | 6 |
| 20 Mar 2019 | Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by… | GETINGE US SALES LLC | Device | Class III | 1 |
| 20 Mar 2019 | Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software version 13.0.302 and higher; Control Console from… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 20 Mar 2019 | VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 20 Mar 2019 | Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging… | GE Healthcare, LLC | Device | Class II | 10 |
| 20 Mar 2019 | DG health NATURALS For Infants 2+ Months+ baby Cough Syrup + Mucus, Natural Grape Flavor, 2 FL OZ (59 mL), UPC: 8 54954 00250 0, Product Code: 003 | Kingston Pharma LLC | Food | Class II | 1 |
| 19 Mar 2019 | OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over. | Carestream Health, Inc. | Device | Class II | 1 |
| 19 Mar 2019 | Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in… | Collagen Matrix, Inc. | Device | Class II | 1 |
| 19 Mar 2019 | Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder, ankle and… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 18 Mar 2019 | Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic,… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 18 Mar 2019 | MRIdian Linac Radiation Therapy System, Model 20000. | Viewray, Inc. | Device | Class II | 1 |
| 18 Mar 2019 | CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR Traffic Light Control Slide provides a positive and negative control for the KT011 GNR Traffic Light PNA FISH kit. GNR Traffic Light PNA FISH provides rapid identification… Event 82665 | Opgen Inc | Device | Class II | 1 |
| 18 Mar 2019 | Vega White Headless Shrimp, 21/15 and 26/30 count size. Frozen block in plastic bag, 6 x 4 lbs. per master carton. Product of the Philippines Processed and Packed by HJR International Corp. Event 82639 | Union Fish Company | Food | Class II | 1 |
| 15 Mar 2019 | Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent. | Cytocell Ltd. | Device | Class III | 1 |
| 15 Mar 2019 | cobas e 801 immunoassay analyzer | Roche Diagnostics Corporation | Device | Class II | 1 |
| 13 Mar 2019 | Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement… | Exactech, Inc. | Device | Class II | 1 |
| 13 Mar 2019 | Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with… | COVIDIEN LLC | Device | Class II | 3 |
| 12 Mar 2019 | Graze, Dark Chocolate Cherry Tart net weight / number of units per package: 1.6oz (44g), 1 unit per package, package type: plastic container (PET/PE) in a cardboard sleeve, units per case: 6 x units per case Event 82385 | NATURE DELIVERED INC | Food | Class II | 1 |
| 11 Mar 2019 | VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides,… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 11 Mar 2019 | RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT… | Brainlab AG | Device | Class II | 1 |
| 11 Mar 2019 | Aji Amarillo Paste, in 40 lb buckets. Event 82632 | Yost Foods, Inc | Food | Class I | 1 |
| 8 Mar 2019 | Trader Joe s Vegetable Melange In Seasoned Butter Sauce Packed in 16 ounce plastic packages retail packaging Bar code: 0033 7038 | Name withheld | Food | Class II | 2 |
| 7 Mar 2019 | Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) processing module is a… | Abbott Gmbh & Co. KG | Device | Class II | 1 |
| 7 Mar 2019 | Atellica IM 1300 Analyzer, Material Number 11066001 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 3 |
| 6 Mar 2019 | FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 5 Mar 2019 | Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set, 9104444 ATF-120 Fast Start Kits… | Fenwal Inc | Device | Class II | 1 |
| 1 Mar 2019 | Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a… | Thoratec Corp. | Device | Class II | 1 |
| 1 Mar 2019 | Basil Olive Oil Flavored Tortilla Seasoning Package Type: Box with liner, Units Per Case: 1, Weight Per Package: 50 pounds Event 82516 | Elite Spice Inc. | Food | Class I | 1 |
| 26 Feb 2019 | MONARCH SOUTHERN BARBECUE SAUCE MADE WITH MUSTARD NET 128 FL OZ(1 GAL) 3.78L INGREDIENTS: WATER, HIGH FRUTOSE CORN SRYUP, SUGAR, TOMATO PASTE, DISTILLED AND CIDER VINEGAR, SALT ***DISTRIBUTED BY/DISTRIBUIDO POR US FOODS, INC., ROSEMOUNT, IL 60015 UPC 7 58108 60016 4 Event 82267 | The CF Sauer Company | Food | Class I | 1 |
| 25 Feb 2019 | Schiff Food, Jalapeno Powder, 50 lb. box Event 82276 | Schiff Foods Products | Food | Class I | 1 |
| 20 Feb 2019 | VITROS 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents | Ortho-Clinical Diagnostics | Device | Class II | 7 |
| 14 Feb 2019 | SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 6 Feb 2019 | Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests. | Medica Corporation | Device | Class II | 1 |
| 5 Feb 2019 | Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma. | Abbott Ireland Diagnostics Division | Device | Class II | 2 |
| 4 Feb 2019 | Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021 | Name withheld | Device | Class II | 2 |
| 4 Feb 2019 | Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use | Roche Diagnostics Corporation | Device | Class II | 1 |
| 30 Jan 2019 | OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the… | Matrix Surgical Holdings, LLC | Device | Class II | 2 |
| 25 Jan 2019 | Fetal Spiral Electrode, Model No. 9898 031 37631 | Philips North America, LLC | Device | Class II | 1 |
| 16 Jan 2019 | Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414 | Polymer Technology Systems, Inc. | Device | Class II | 3 |
| 16 Jan 2019 | CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 | Name withheld | Device | Class III | 2 |
| 14 Jan 2019 | Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures. | Arthrex, Inc. | Device | Class II | 1 |
| 11 Jan 2019 | Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot. | Lin-Zhi International Inc | Device | Class III | 1 |
| 11 Jan 2019 | El Guapo Chile Habanero Habanero Chili Pepper 0.5oz | McCormick & Company, Inc. - Flavor Manufacturing Center | Food | Class I | 2 |
| 10 Jan 2019 | DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum. | PerkinElmer Life and Analytical Sciences, Wallac, OY | Device | Class II | 3 |
| 8 Jan 2019 | Chips & Chocolate, A layered dessert with chocolate mousse layer on the bottom, with a white whipped topping layer on top topped with chocolate chips, 5 lb. tray, UPC Code 010742015408 | Winter Gardens Quality Foods, Inc. | Food | Class I | 1 |
| 31 Dec 2018 | cone-beam CT system Event 82045 | KaVo Dental Technologies LLC | Device | Class II | 1 |
| 19 Dec 2018 | Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal infection. The serum concentration of… Event 82551 | Associates of Cape Cod, Inc. | Device | Class II | 1 |
| 18 Dec 2018 | Fannie May Pixies , Caramel and Pecan Clusters covered in Milk Chocolate 14 oz. Box - 12 units per case Event 81856 | Fannie May Confections Brands, Inc | Food | Class II | 1 |
| 13 Dec 2018 | Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for… | Arrow International Inc | Device | Class II | 2 |
| 7 Dec 2018 | Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398 | Siemens Healthcare Diagnostics, Inc | Device | Class II | 4 |
| 3 Dec 2018 | Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system… | PENTAX of America Inc | Device | Class II | 3 |
| 20 Nov 2018 | Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000 | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 19 Nov 2018 | St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic… | Abbott | Device | Class II | 1 |
| 13 Nov 2018 | EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light… Event 82476 | Name withheld | Device | Class II | 1 |
| 13 Nov 2018 | Little Ones Pretzels 4.5lb, 1 polyethylene bag per corrugated container. Event 81592 | Tom Sturgis Pretzels, Inc. | Food | Class II | 1 |
| 6 Nov 2018 | Product labeled "Herb Roasted Potatoes", packed in 16oz plastic tray with clear plastic shrink-wrapping. Product is visible through clear plastic wrap. Product inside is Baked Potatoes with Cheddar Cheese and Bacon. | Ukrop's Homestyle Foods, LLC | Food | Class I | 1 |
| 22 Oct 2018 | NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the… | Neusoft Medical Systems Co., Ltd. | Device | Class II | 3 |
| 15 Oct 2018 | BEECHERS GLUTEN FREE KALE AND RICE GARTIN, Net wt. 20 Oz. (1lb. 4.0 oz ) 567 g / 9 cartons/case | Caesar's Pasta, LLC | Food | Class II | 2 |
| 15 Oct 2018 | Trace Minerals Dietary Supplement , 16.2 fl oz (480 mL) bottles, Packaged in dark blue plastic bottles, For freshness, keep refrigerated after opening Event 82460 | Mineralife LLC | Food | Class II | 1 |
| 11 Oct 2018 | M200 Fall Monitoring System | Stanley Security Solutions Inc | Device | Class II | 1 |
| 4 Sep 2018 | Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue. Event 82540 | Name withheld | Device | Class I | 1 |
| 28 Aug 2018 | Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine. | Abbott Laboratories, Inc | Device | Class II | 1 |
| 24 Aug 2018 | TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a… | TriMed Inc. | Device | Class II | 1 |
| 22 Aug 2018 | Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically prescribed fluids, designed to reduce the… | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 30 Jul 2018 | UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The… | Beckman Coulter Inc. | Device | Class I | 3 |
| 4 Jul 2018 | Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. | Medtronic Inc. | Device | Class II | 1 |
| 27 Jun 2018 | Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning. | Elekta Instrument AB | Device | Class II | 1 |
| 21 Jun 2018 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and… | Baxter Healthcare Corporation | Device | Class II | 1 |
| 2 Feb 2018 | Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO. | Shippert Medical Technologies | Device | Class II | 7 |
| 8 Nov 2017 | Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad,… | Bard Medical Division | Device | Class II | 1 |
| 22 Sep 2017 | Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield,… | Guangzhou Improve Medical Instruments Co., Ltd. | Device | Class II | 1 |
| 21 Nov 2016 | CryoPatch SG Pulmonary Hemi-Artery Patch | CryoLife, Inc. | Device | Class II | 1 |