| 10 Jan 2017 | Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. | Elekta, Inc. | Device | Class II | 1 |
| 4 Jan 2017 | AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00555 I2020/C55F SA F00558 IS2025/C55 SA F00559 IS2025/C65 SA F0072605 A2525/C75O20 V F0072606 A2525/C95O20 V f00552 I1616/C88 SA F00557 I2013/C88F SA The… | Endologix | Device | Class II | 2 |
| 4 Jan 2017 | Starkey Spring Water, 16.9 FL oz. (500 mL) glass bottle. packed 15 bottles in cardboard box. Product UPC 8 11904 02000 7. Case UPC 8 11904 02002 1. (76172) | Individual firm, name withheld | Food | Class III | 1 |
| 3 Jan 2017 | FPI Breaded Round Shrimp Tail-On 1001990, 12-8 oz. cartons per master case, Master case 6 lbs. (2.72 kg) | High Liner Foods, Inc. | Food | Class I | 1 |
| 3 Jan 2017 | Croissant:: sold in self serve cases and 4 pack clamshell package. Ingredients: Dough (enriched unbleached flour [wheat flour, malted barley flour, niacin, iron, thiamin, mononitrate, riboflavin, folic acid] water, butter, sugar, milk, yeast, salt, ascorbic acid, enzymes. Topping (egg spray). Contains Milk, Eggs,… | Bakers Of Paris, Inc. | Food | Class I | 4 |
| 28 Dec 2016 | Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840 | L. Perrigo Company | Drug | Class II | 1 |
| 28 Dec 2016 | Kabayaki Unagi Bits (Broiled Eel Bits) Tetsujin (76135) | Ming Hong International,Inc. | Food | Class I | 1 |
| 27 Dec 2016 | AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA). | Endologix | Device | Class II | 1 |
| 27 Dec 2016 | AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA). | Endologix | Device | Class II | 1 |
| 27 Dec 2016 | AFX Endovascular AAA System, Endoleak Type IIIA | Endologix | Device | Class II | 1 |
| 27 Dec 2016 | AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment | Endologix | Device | Class II | 1 |
| 27 Dec 2016 | AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA). | Endologix | Device | Class II | 1 |
| 27 Dec 2016 | AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA). | Endologix | Device | Class II | 1 |
| 23 Dec 2016 | Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer. | Elekta, Inc. | Device | Class II | 1 |
| 22 Dec 2016 | Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10 | Sandoz Incorporated | Drug | Class II | 1 |
| 22 Dec 2016 | TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21 | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 22 Dec 2016 | Signature Kitchens Tuna Chunk Light 20 oz. (4 pack), 12 oz., 5 oz. UPC Codes: 2113033549, 2113035609, 2113035612 | SAFEWAY INC | Food | Class II | 2 |
| 21 Dec 2016 | Fresenius 2008T Series Hemodialysis System | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 4 |
| 21 Dec 2016 | AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and… | Beckman Coulter Inc. | Device | Class III | 1 |
| 21 Dec 2016 | Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy. | Elekta, Inc. | Device | Class II | 1 |
| 21 Dec 2016 | the Peanut Principle, Dashing Thru the Dough, Gourmet Chocolate Chip Cookie Dough Peanut Butter, NET WT 16oz, UPC 609207898788 (76063) | Capitol City Specialties Company | Food | Class II | 1 |
| 21 Dec 2016 | Tupperware, Southwest Chipotle Seasoning, Assaisonnement Chipotle du sud-ouest, NET WT. 2.0 OZ. (56g) | J M Exotic Foods Inc | Food | Class I | 2 |
| 21 Dec 2016 | Fresh Express Hearts of Romaine salad, 9 oz., clear/labeled salad bag/ 6 bags per case (76057) | Fresh Express, Inc. | Food | Class I | 1 |
| 20 Dec 2016 | Dieffenbach's Sour Cream and Onion Kettle Chips 9 oz. and 2 oz. bags (76032) | Dieffenbach's Potato Chips, Inc. | Food | Class II | 1 |
| 20 Dec 2016 | Smoked Chipotle Flavored Kettle Cooked Potato Chips 2.625 oz and 8.0 oz | Herr Foods, Inc. | Food | Class II | 2 |
| 20 Dec 2016 | Chocolate Chip Sea Salt Cookies, Hungry Heart brand. Product is packaged in a clear cello bags, heat sealed. 1 unit per bag. Net wt. 2.75 oz. (78g). | Hungry Heart Bakery | Food | Class II | 4 |
| 19 Dec 2016 | SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius | In2Bones, SAS | Device | Class II | 3 |
| 19 Dec 2016 | RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223 | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 19 Dec 2016 | MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc¿ trays per case and 160 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular… | Bard Access Systems | Device | Class II | 2 |
| 19 Dec 2016 | UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304 | Beckman Coulter Inc. | Device | Class II | 2 |
| 19 Dec 2016 | OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and… | GE OEC Medical Systems, Inc | Device | Class II | 3 |
| 19 Dec 2016 | ALN UNICED 1/4 Sheet Split Layer White Cake, Item 00886, three stacked cake layers with plastic liner in between layers are packaged in a corrugated box, a total of 12 cakes per bulk box. UPC 00750903008862 (76022) | Portland Specialty Baking LLC | Food | Class II | 1 |
| 18 Dec 2016 | Winco Foods Creamy Ranch Dressing 16 fl oz. UPC Code: 0 70552 70103 8 | Vanlaw Food Products, Inc | Food | Class I | 1 |
| 18 Dec 2016 | House Autry, stone Ground Buttermilk Corn Bread Mix, Net wt. 8 oz. boxes, UPC Code 0 73484 15512 2, | House-Autry Mills, Inc | Food | Class II | 7 |
| 16 Dec 2016 | IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 16 Dec 2016 | APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 16 Dec 2016 | Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images. (76187) | DICOM GRID INC | Device | Class II | 1 |
| 16 Dec 2016 | Tipiak Pearled Couscous Easy cooking 12.3 Oz (350g) Item Number: 10020450803 Product of France (75988) | TIPIAK Inc | Food | Class II | 1 |
| 16 Dec 2016 | GREEN BEAN SAUCE SEASONING NET WEIGHT: 50.00 LBS | Chesapeake Spice Company, LLC | Food | Class II | 3 |
| 16 Dec 2016 | Fresh Strawberry Boston - FRZ and Fresh Strawberry Boston Cake packaged on plastic trays with domed lids. | HEB Retail Support Center | Food | Class I | 6 |
| 15 Dec 2016 | TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and… (76014) | Infraredx, Inc. | Device | Class II | 1 |
| 15 Dec 2016 | Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007 | Gentell, Inc | Drug | Class II | 2 |
| 15 Dec 2016 | LIZARD FISH (Eviscerated), 15 KGS, PRODUCT OF VIETNAM --- DISTRIBUTED BY ARCADIA TRADING INC. BROOKLYN, NY 11211 (75976) | Arcadia Trading Inc. | Food | Class I | 1 |
| 15 Dec 2016 | Starkey Spring Water, Item code STC.5, 16.9 FL oz. (500 mL) glass bottle. Product UPC 8 11904 02000 7. Case UPC 8 11904 02002 1. (75996) | Individual firm, name withheld | Food | Class III | 1 |
| 14 Dec 2016 | NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and… | Ultradent Products, Inc. | Device | Class II | 1 |
| 14 Dec 2016 | Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01 | Apotex Corp. | Drug | Class II | 2 |
| 14 Dec 2016 | Cranberry Orange Scone, brand Mad Batter Bakery, net wt. 5 oz per unit. Product is sold in a plastic film wrapper with labeling on the back of the package. (75959) | Thomas Hammer Coffee Roasters, Inc. | Food | Class I | 1 |
| 14 Dec 2016 | Delizza Patisserie, Belgian Custard Cream Mini Eclairs, Net Wt. 420g 14.8 oz., UPC Code: 6 76670 00106 9(30 count) and Net Wt. 700g 24.6 oz., UPC Code: 6 76670 00105 2 (50 count). | Poppie International INC | Food | Class I | 3 |
| 14 Dec 2016 | Birdman Bread, each loaf has net wt. 24 oz and 32 oz.. The UPC code ia 6 36428 10200 4. | Great Northern Bakehouse Inc. dba Le Petit Outre | Food | Class II | 7 |
| 14 Dec 2016 | Shelled Pistachios 7.3 oz. packaged in a clear plastic tub, Central Market Shelled Pistachios 7.3 oz. packaged in a clear plastic tub, SunRidge Farms Pistachio Nuts Bulk PLU# 70289 | HEB Retail Support Center | Food | Class I | 4 |
| 13 Dec 2016 | Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces… | Siemens Medical Solutions USA Inc. | Device | Class II | 11 |
| 13 Dec 2016 | Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540. | Sandoz Inc | Drug | Class III | 1 |
| 13 Dec 2016 | Texas Kitchen Salads Tropical Fruit Supreme KEEP REFRIGERATED Nutrition Facts NET WT. 16 oz. in plastic containers, Packed By: Ron's Home Style Foods, Inc. Houston, TX 77021 UPC: 0 96938 84101 3 | Ron's Home Style Foods, Inc. | Food | Class I | 3 |
| 13 Dec 2016 | Williams-Sonoma Meyer Lemon Poppy Quick bread mix, NET WT. 1 LB. 2 OZ (509 g) (75985) | Williams-Sonoma | Food | Class II | 1 |
| 13 Dec 2016 | Linden's brand Chocolate Chip Cookies: a) Chocolate Chippers Bite Size Cookies (Mini), NET WT. 2 OZ., UPC 76809-30017; b) Chocolate Chippers (Mini), NET WT 1.1 OZ., UPC 76809-30090; c) 3 LARGE CHOCOLATE CHIP COOKIES (Pack), NET WT. 1.75 OZ. UPC 76809-30010 --- LINDEN COOKIES, INC. 25 BRENNER DRIVE CONGERS, NY 10920 (75931) | Linden Cookies, Inc | Food | Class I | 1 |
| 12 Dec 2016 | AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton. | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 12 Dec 2016 | Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package. (75948) | Individual firm, name withheld | Device | Class II | 1 |
| 12 Dec 2016 | Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus… (76076) | Great Basin Scientific, Inc. | Device | Class II | 1 |
| 12 Dec 2016 | Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count bottle, Rx only, Made in Canada, NDC 76439-357-90 | Individual firm, name withheld | Drug | Class III | 4 |
| 12 Dec 2016 | 4 oz. Complete Cookie, Chocolate Chip, UPC Code: 7 87692-83461 7, 12pks: 231,114 sleeves (contains 12 cookies) 6pks: 54,660 sleeves (contains 6 cookies) 4pks: 795,528 sleeves (contains 4) Total cookies from all pack sizes above: 6,283,440 | Lenny & Larry's, Inc. | Food | Class I | 2 |
| 12 Dec 2016 | Charles Chocolates Toffee Chocolate Macadamia; NET WT. 6.2 oz .(180 grams) UPC: 8 59033 00440 6 Charles Chocolates, San Francisco, CA (75944) | Chocolate Holdings Inc. DBA Charles Chocolates | Food | Class II | 1 |
| 12 Dec 2016 | Tropical Fruit Supreme, packaged under the following brands: (a) St. Clair, product code 104001, ST. CLAIR FOODS, INC., NET WT. 5 LBS (2.27 kg), MEMPHIS, TN 38116, UPC 7717114001 (b) Classic SYSCO(R), product code 1527001, NET WT. 5 LBS (2.27 kg), DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TX, 77077-2099, UPC… | St Clair Foods, Inc. | Food | Class I | 3 |
| 12 Dec 2016 | NEW HOPE MILLS Crepe MIX, NET WT. 1 LB. 4 OZ, UPC 074703601529 --- 181 York Street, Auburn, New York 13021 ---Product is packaged in a brown paper bag | New Hope Mills Mfg., Inc. | Food | Class II | 1 |
| 9 Dec 2016 | Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior | Merge Healthcare, Inc. | Device | Class II | 1 |
| 9 Dec 2016 | Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. | Medtronic Inc., Cardiac Rhythm and Heart Failure | Device | Class II | 1 |
| 9 Dec 2016 | StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a… | Bard Access Systems | Device | Class II | 2 |
| 9 Dec 2016 | AMERICAN CLASSIC SUB Net Wt 6.5 oz (184g) Smoked ham, deli style bologna, hard salami with American and Swiss cheese on an Italian bun KEEP REFRIGERATED UPC 6 42984 67594 4 | EBY BROWN CO | Food | Class II | 10 |
| 9 Dec 2016 | HEB Homestyle White Corn Tortillas, 12 Count and 30 Count packaged in clear plastic bags. (75927) | H-E-B Corpus Christi Operations | Food | Class II | 1 |
| 9 Dec 2016 | Cardboard sleeve: Double Takes Macaroni & Cheese Dinner, Distributed By: Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320; Double Takes: Best By: 10/11/17 10/12/17 10/13/17 10/19/17 10/20/17 10/24/17 11/28/17 11/29/17 11/30/17; UPC: 63927701208: | Fourth Street Barbeque, Inc. | Food | Class II | 2 |
| 9 Dec 2016 | Dark Chocolate Dolcini, In clear plastic cup, 72 individual servings, Store frozen | Steven Roberts Originals, LLC | Food | Class I | 2 |
| 9 Dec 2016 | Stonewall Kitchen Cinnamon Apple Pancake & Waffle Mix, 16 oz. canister UPC: 711381025659 Item #: 551118 | Stonewall Kitchen, LLC | Food | Class II | 3 |
| 9 Dec 2016 | Opelle Bakery Egg Bagel (C-105), case of 60 (3.5 oz.), Frozen Raw. | O'Pelle Enterprises, Inc. | Food | Class II | 3 |
| 8 Dec 2016 | Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device. | Trilliant Surgical Ltd. | Device | Class II | 1 |
| 8 Dec 2016 | Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are 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 with the Artis… | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 8 Dec 2016 | Grab & Go Chicken Salad on Croissant Packed by World Food LLC Orlando FL 32837 Net WT 8oz | World Food LLC. | Food | Class II | 1 |
| 8 Dec 2016 | In The Mix¿ Monkey Bread Mix NET WT 16 oz (16 lb) 454 g box, INGREDIENTS: BREAD MIX: ***BUTTERMILK*** DISTRIBUTED BY BRAND CASTLE, LLC BEDFORD HTS, OH 44146 www.brandcastle.com UPC 8 44527 03278 2 (75902) | Brand Castle LLC | Food | Class II | 1 |
| 8 Dec 2016 | Sun Caf¿ (D Blend) Spice Chai Net Wt. 2 lbs. Made in USA for Sun Cafe Company for Trading Kingdom of Saudi Arabia 920002017 | American Instants, Inc. | Food | Class I | 4 |
| 8 Dec 2016 | Country Gardens Cuisine, Singles, Broccoli Cheese Soup with Rice, Net Wt. 1.25 oz (35 grams) (75903) | Copperleaf Kitchen, LLC Comfort Foods Division | Food | Class I | 1 |
| 7 Dec 2016 | Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw… | Medacta Usa Inc | Device | Class II | 1 |
| 7 Dec 2016 | Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654 (76233) | Novum Pharma, LLC | Drug | Class III | 1 |
| 7 Dec 2016 | Wilbur; IM10021; B558 Semisweet Chocolate Drops, 2000 CT; Net Weight 50 lb.; This item may contain dairy products; Cargill Cocoa & Chocolate, Inc., Lititz, PA 17543; BATCH 28116AANCB and 28116AANCC Material number: 100000081 packed in cardboard boxes. | Cargill Cocoa & Chocolate, Inc. | Food | Class I | 1 |
| 7 Dec 2016 | Publix Premium Banana-Flavored Chocolate Chip Pancake & Waffle Mix, 16 oz box. | Publix Super Markets, Inc. | Food | Class II | 3 |
| 7 Dec 2016 | United Food Ingredients, Inc. Blue Cheese Snack Seasoning, NET WT. 50.0 lbs., 15W700 South Frontage Road, Burr Ridge, IL 60527 | United Food Ingredients, Inc. | Food | Class I | 2 |
| 7 Dec 2016 | Biscuits & Gravy Seasoning CR/ Barrel O' Fun. Product Code: T3669. 50 lb bags | All American Seasonings, Inc. | Food | Class I | 26 |
| 7 Dec 2016 | N-C Butter Flavor Nat WONF, NET WEIGHT: 50 LBS, FONA International, Inc., 1900 Averill road, Geneva, IL 60134 | Individual firm, name withheld | Food | Class I | 5 |
| 6 Dec 2016 | Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier.… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 6 Dec 2016 | Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects to the appropriate equipment. The cables… | Stryker Sustainability Solutions | Device | Class II | 2 |
| 6 Dec 2016 | 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06 | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 6 Dec 2016 | INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01 (76011) | Cipher Pharmaceuticals US LLC | Drug | Class III | 1 |
| 5 Dec 2016 | OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt. | Acumed LLC | Device | Class II | 1 |
| 5 Dec 2016 | Pudin es Cedo***Homestyle Caramel Bread Pudin***Ready to Eat***Hecho en Puerto Rico***Serving Size 3 oz (85g) (75916) | Elmec Industries, Inc. | Food | Class II | 1 |
| 2 Dec 2016 | Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures requiring percutaneous introduction of… | BARD PERIPHERAL VASCULAR, INC | Device | Class I | 3 |
| 2 Dec 2016 | Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to final implantation into the glenoid vault.… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 2 Dec 2016 | Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through… | CareFusion 303, Inc. | Device | Class I | 1 |
| 2 Dec 2016 | Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external… | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 2 Dec 2016 | Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81 (75880) | Shire PLC | Drug | Class III | 1 |
| 2 Dec 2016 | Derby City Vending Buffalo Chicken Sandwich Deli Selections Ingredients: Chicken***Ranch Cup; Pretzel bun***Lettuce, Tomato CONTAINS WHEAT Fresh Thru 12/4/16 Derby City Vending Louisville, KY 40206 (75849) | Derby City Vending Inc | Food | Class I | 1 |
| 2 Dec 2016 | Refrigerated, Ready to Eat Herring in Brine with no brand name, packaged in bulk 25 lb. white plastic bucket and labeled in part, ** 204250 ** HERRING ISLANDSKAYA JUMBO BY PC ** (label on the metal handle of bucket) | Royal Seafood Baza, Inc. | Food | Class I | 17 |
| 2 Dec 2016 | Non Fat Dry Milk, Grade A - High Heat in 50 # bags , manufactured by Valley Milk Products. Stasburg, Virginia 22657 , Permit No. 51-4136 Net Weight - 50 LBS | Valley Milk Products | Food | Class I | 2 |
| 1 Dec 2016 | Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that… | PerkinElmer Health Sciences, Inc. | Device | Class II | 1 |
| 1 Dec 2016 | TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device | Pride Mobility Products Corp | Device | Class II | 1 |
| 1 Dec 2016 | PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of… | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 1 Dec 2016 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 1 Dec 2016 | Kerry Upgrade Bio WS, Net Wt. 50 lb (22068 kg), Item 5R01451. | Kerry, Inc | Food | Class II | 1 |
| 30 Nov 2016 | Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly. | Boston Scientific Corporation | Device | Class II | 1 |
| 30 Nov 2016 | 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through… | ICU Medical, Inc. | Device | Class II | 1 |
| 29 Nov 2016 | symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, C24136 Product Usage: sterilization container | Symmetry Surgical, Inc. | Device | Class II | 3 |
| 28 Nov 2016 | GoDirect Screw-Retaining Top Part Numbers: 4500-61 | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 25 Nov 2016 | Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports,… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 23 Nov 2016 | MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens. | BioMerieux SA | Device | Class I | 2 |
| 23 Nov 2016 | i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448 (76102) | HEALTH ROBOTICS S.R.L. | Device | Class II | 1 |
| 23 Nov 2016 | Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016. | Allen Medical Systems, Inc. | Device | Class II | 1 |
| 23 Nov 2016 | Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple… | Straumann Manufacturing, Inc. | Device | Class II | 2 |
| 23 Nov 2016 | LONGAN ARIL, NET WT: 10.6oz (300g), contains blue labeling | Midwest International Corp | Food | Class II | 2 |
| 23 Nov 2016 | Andersons Pumpkin Pie ice cream pie, 8 inch round ice cream pie with whipped frosting --- The pie is packaged in a 9 inch round clear plastic dome container (75804) | Individual firm, name withheld | Food | Class I | 1 |
| 22 Nov 2016 | SOMATOM Scope, Computed tomography x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 22 Nov 2016 | G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease… (75882) | Interventional Spine Inc | Device | Class II | 1 |
| 22 Nov 2016 | Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1. | Amendia, Inc | Device | Class II | 1 |
| 22 Nov 2016 | SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK For in… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 22 Nov 2016 | Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241. (75810) | J&J Solutions, Inc. DBA Corvida Medical | Device | Class II | 1 |
| 22 Nov 2016 | MULLIGATAWNY, Net wt 6.9 lbs, UPC 1 80644 00041 0, packaged in a heat sealed flexible plastic bag. | Hale And Hearty Soups, LLC | Food | Class I | 2 |
| 21 Nov 2016 | GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes… (75827) | Tepha Incorporated | Device | Class II | 1 |
| 21 Nov 2016 | Innova 2000 | GE Healthcare, LLC | Device | Class II | 13 |
| 21 Nov 2016 | Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body | Carestream Health Inc | Device | Class II | 1 |
| 21 Nov 2016 | Big Red Fresh Tomatoes, 5x6/6x6/6x7, 25 lb cardboard boxes. Distributed by Big Red Tomatoes. Kept refrigerated. (75777) | BIG RED TOMATO PACKERS, LLC | Food | Class I | 1 |
| 20 Nov 2016 | Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator. | Shimadzu Medical Systems | Device | Class II | 1 |
| 20 Nov 2016 | Shimadzu X-ray TV System, Catalog No. SONIALVISION G4 | Shimadzu Medical Systems | Device | Class II | 1 |
| 18 Nov 2016 | FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 18 Nov 2016 | CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162 | Raritan Pharmaceuticals, Inc. | Drug | Class II | 3 |
| 18 Nov 2016 | Sabra Hummus Caramelized Onion, 10 OZ, UPC 40822014700, SKU 300051 | Sabra Dipping Company, LLC | Food | Class I | 20 |
| 17 Nov 2016 | PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This | MicroPort Orthopedics Inc. | Device | Class II | 1 |
| 17 Nov 2016 | Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium Picolinate 200 mcg/Glutamine (L) 30… | Tri-Coast Pharmacy | Drug | Class II | 80 |
| 16 Nov 2016 | REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116 | Smith & Nephew, Inc. | Device | Class II | 1 |
| 15 Nov 2016 | Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any… | Smith & Nephew, Inc. | Device | Class II | 3 |
| 15 Nov 2016 | DRIED SILVER FISH, N.W. 30 LBS, PRODUCT OF CHINA (75697) | WD IMPORT AND EXPORT INC. | Food | Class I | 1 |
| 11 Nov 2016 | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced… | Smith & Nephew, Inc. | Device | Class II | 2 |
| 11 Nov 2016 | Ashby's Sterling Peanut Butter Landslide Ice Cream, 3 gallon container, frozen | House Of Flavors, Inc. | Food | Class I | 1 |
| 9 Nov 2016 | Market Pantry Peanut Butter Cookies. Net Wt. 10.8 oz (306g) UPC 92180 11707 (75647) | Minnesota Best Maid Cookie Co. Inc. | Food | Class II | 1 |
| 9 Nov 2016 | Kahuko Ogo Stored at 40F: Packed in plastic bags in varying weights from 0.5 lb. to 35 lb. No codes on product. Marine Agrifuture, LLC 56-1081 Kamehameha Hwy Kahuku, HI 96731 | Marine AgriFuture, LLC | Food | Class I | 3 |
| 9 Nov 2016 | Fabi-saa Melcochas Candy Net Wt. 8 oz. Fabi-Saa Inc. 39 Montgomery Street Belleville, NJ 07936 UPC 181683000676 (75800) | Fabi-saa Inc. | Food | Class II | 1 |
| 8 Nov 2016 | PREMIER EHEC and PREMIER EHEC Bulk. | Meridian Bioscience Inc | Device | Class II | 1 |
| 8 Nov 2016 | Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol), packaged in a) 4 oz. bottles (NDC 46706-201-01), b) 8 oz bottles (NDC 46706-201-02), c) 16 oz. bottles (NDC 46706-201-03), d) 12 oz. pumpette (NDC 46706-201-05), e) 32 oz. bottles (NDC 46706-201-06), OTC, Care-Tech… (75535) | Care-Tech Laboratories, Inc. | Drug | Class III | 1 |
| 7 Nov 2016 | Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15. | Exactech, Inc. | Device | Class II | 3 |
| 5 Nov 2016 | Limu Poke is fresh refrigerated product, distributed in bulk kit, net wt. 4.35 lbs. Each kit includes five individually packages [tuna, onions, limu (ogo seeweed), wet sauce mix, and dry sauce mix]. Each bulk kit is labeled with Costco item #13355. Costco deli department would upack the kit, mix all five components,… (75684) | Western United Fish Company, Inc. | Food | Class I | 1 |
| 4 Nov 2016 | Fresh Catch Smoked Baby Clams 3.53 oz. pouch (100g) Item Number 541187381, UPC 087381043895 (75874) | Mitsui Foods Inc | Food | Class II | 1 |
| 3 Nov 2016 | VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restorative, core build-up or luting materials. It can be applied with phosphoric acid etching (selective enamel etching or total-etch) of the dental hard tissue as well as without… | Voco GmbH | Device | Class II | 1 |
| 31 Oct 2016 | ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the… | ConforMIS, Inc. | Device | Class II | 1 |
| 28 Oct 2016 | Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 28 Oct 2016 | Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 27 Oct 2016 | Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic | Brainlab AG | Device | Class II | 1 |
| 18 Oct 2016 | HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459 (75700) | Town and Country Compounding and Consultation Services, LLC | Drug | Class III | 1 |
| 15 Oct 2016 | Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the… (75846) | Natus Manufacturing Limited | Device | Class II | 1 |
| 12 Oct 2016 | Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient | Bausch & Lomb, Inc. | Device | Class II | 1 |
| 12 Oct 2016 | Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04 | Pharm D Solutions, LLC | Drug | Class III | 2 |
| 10 Oct 2016 | Label reads in part as: "Ced¿ Pud¿n***Keep Refrigerated***NET WT 20 OZ (566 g)***Manufactured and Packed by Elmec Industries Inc.***229 Guanajibo Rd. Mayaguez, P.R. 00681". (75392) | Elmec Industries, Inc. | Food | Class II | 1 |
| 5 Oct 2016 | VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ… | ORTHO-CLINICAL DIAGNOSTICS | Device | Class II | 1 |
| 4 Oct 2016 | Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush (75348) | Nurse Assist, Inc | Device | Class I | 1 |
| 27 Sep 2016 | EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level… | Advanced Sterilization Products | Device | Class II | 1 |
| 21 Sep 2016 | Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Wells Pharmacy Network LLC | Drug | Class II | 97 |
| 20 Sep 2016 | BLUE BELL(R) ICE CREAM Chocolate Chip Cookie Dough, Half Gallon, Pint, and 3 Gallon sizes. | Blue Bell Creameries, L.P. | Food | Class I | 4 |
| 20 Sep 2016 | NO EGG CHOCOLATE CHIP COOKIE DOUGH 03-3014, Net Weight 30 lb (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438 | Aspen Hills, Inc. | Food | Class I | 19 |
| 9 Sep 2016 | Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34 | Pfizer Inc. | Drug | Class III | 1 |
| 9 Sep 2016 | Liquid VITAMIN D-3 Drops distributed under the following private labels and sizes: a) NATURE'S ANSWER VITAMIN D-3 DROPS DIETARY SUPPLEMENT, 0.5 FLUID OZ/15 mL, UPC 8300026132 -- Nature's Answer Hauppauge, NY 11788; and b) Seeking Health Optimal Vitamin D, Liquid Vitamin D-3 Drops, 2000 IU per drop, 1 FL. OZ. (30 ML),… (75179) | Bio-Botanica, Inc. | Food | Class II | 1 |
| 5 Sep 2016 | Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal | Alcon Research, Ltd. | Device | Class II | 1 |
| 2 Sep 2016 | IBF Peanut Butter, Net Weight 450 lbs, Hampton Farms, Severen, NC 27877. (75220) | Hampton Farms Industrial Plant | Food | Class II | 1 |
| 31 Aug 2016 | NeuViz 64 Multi-slice CT Scanner Systems | Neusoft Medical Systems Co., Ltd. | Device | Class II | 2 |
| 31 Aug 2016 | Koi Palace Mini Moon Cake: Mini Egg Yolk in White Lotus Seed Paste: Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces). | Magic Gourmet Trading Inc | Food | Class II | 16 |
| 25 Aug 2016 | Wal-Mart, Marketside Veggie Kabobs 23oz | Country Fresh Products, LLC | Food | Class I | 22 |
| 24 Aug 2016 | Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle… | ICU Medical, Inc. | Device | Class II | 1 |
| 22 Aug 2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3 | Noven Pharmaceuticals, Inc. | Drug | Class II | 3 |
| 4 Aug 2016 | Infant Warmer System (IWS) | GE Healthcare, LLC | Device | Class II | 1 |
| 27 Jul 2016 | Carolina Moon, typical wheel is about .55 lb, Chapel Hill Creamery, Chapel Hill, NC 27516, sold by weight. | Chapel Hill CreameryLLC | Food | Class I | 13 |
| 20 Jul 2016 | Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed. | Sterling Diagnostics, Inc. | Device | Class III | 9 |
| 11 Jul 2016 | SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device | C.R. Bard, Inc. | Device | Class II | 1 |
| 5 Jul 2016 | Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit. | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 28 Jun 2016 | NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged. | Medtronic Xomed, Inc. | Device | Class II | 1 |
| 22 Jun 2016 | Star shaped, blue frosted tea cookies. The cookies were delivered in plain white pastry boxes and sold unpackaged at the supermarket on the supermarkets Tea Cookie Display. (74658) | Starlight Creatives, Inc. | Food | Class II | 1 |
| 25 Apr 2016 | BREAM - DRY EVISCERATED SALTED FISH, 5.29 oz. (150g), UPC 4606495001346 --- Product is vacuum packed and consists of salted dry bream fish. | Krasnyi Oktyabr Inc. | Food | Class I | 2 |
| 28 Mar 2016 | Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 15 Oct 2015 | DR Systems Unity PACS software, now known as Merge Unity PACS software. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 13 Oct 2015 | Bionix, 30 capsules per bottle | Sunset Natural Products Inc. | Food | Class II | 163 |
| 7 Aug 2015 | Bayside Seasoning, 2 lb plastic jar, product number 61497 | PIAZZA PRODUCE, INC. | Food | Class II | 24 |
| 13 May 2015 | Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in… | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 19 Feb 2013 | Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device. | Hospira Inc. | Device | Class II | 1 |
| 28 Nov 2012 | Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases. | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 9 Oct 2012 | Digital RID Plate Reader and Software Product Code: AD400 | The Binding Site Group, Ltd. | Device | Class II | 1 |