| 14 Apr 2014 | Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102"). | Merit Medical Systems, Inc. | Device | Class II | 2 |
| 14 Apr 2014 | Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06 | Upsher Smith Laboratories, Inc. | Drug | Class III | 1 |
| 14 Apr 2014 | Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL… | P&L Developments, LLC | Drug | Class III | 1 |
| 11 Apr 2014 | Jolly Time Microwave popcorn, Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton UPC 028190007876, on the 12-ct case - UPC 10028190007804 and 48-ct case UPC 128190487873 American Pop Corn Company, Sioux City, IA. | American Pop Corn Co | Food | Class II | 3 |
| 9 Apr 2014 | Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS. | Edwards Lifesciences, LLC | Device | Class II | 2 |
| 9 Apr 2014 | ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter | Ev3, Inc. | Device | Class II | 1 |
| 8 Apr 2014 | Tikosyn (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60 | Pfizer Inc. | Drug | Class II | 1 |
| 7 Apr 2014 | Natural Grocers by Vitamin Cottage, Pepper Black Whole Organic, about 0.30 lb, UPC 201046804762, packaged in plastic bags. | Natural Grocers by Vitamin Cottage | Food | Class I | 1 |
| 4 Apr 2014 | Sprouts Farmers Market Organic Whole Black Peppercorns, 2.12oz., UPC Code 8-74875-00425-4, Lot Numbers 3287 and 3246. Packaged in glass jars with plastic lid. Product labeling reads in part:"SPROUTS FARMERS MARKET organic Black Peppercorns ***NET WT 2.12 OZ (60g)***Manufactured Exclusively For Sprouts Farmers Market… | Sprout's Farmers Market | Food | Class I | 1 |
| 4 Apr 2014 | The Kitchen Whole Foods Chipotle Chicken Wrap; Good to Go. Net Weight: 10 oz.. (283 g) individually wrapped sandwich wraps. Distributed by Green Shoots Distribution' So. San Francisco, 94083 | Whole Foods Market | Food | Class II | 1 |
| 4 Apr 2014 | Lisy Sweet Basil Albahaca Net WT/Cont. Neto 6oz. (171g) Item 1132 www.lisycorp.com Packed on a clear plastic container with a UPC # 0 96786 30032 8 Event 67962 | Lisy Corp. | Food | Class I | 1 |
| 4 Apr 2014 | 1) Frontier Natural Products Co-op, Whole Black Peppercorns, Certified Organic, Piper nigrum. Net 11.3 Kg 25 LB. Packaged in corrugated cardboard boxes. Firm name on the label is Frontier in Norway, IA. UPC 0-89836-82603-9.; 2) Frontier Natural Products Co-op, Whole Black Peppercorns, Certified Organic, Piper nigrum.… | Frontier Natural Products Co-op | Food | Class I | 1 |
| 3 Apr 2014 | iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology. | Boston Scientific Corporation | Device | Class II | 1 |
| 2 Apr 2014 | GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device. | GE Healthcare, LLC | Device | Class II | 1 |
| 2 Apr 2014 | Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 2 Apr 2014 | Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 2 Apr 2014 | Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator. | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 1 Apr 2014 | TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component. | Zimmer, Inc. | Device | Class II | 1 |
| 1 Apr 2014 | Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery. | Micro Therapeutics Inc, Dba Ev3 Neurovascular | Device | Class I | 2 |
| 31 Mar 2014 | Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator. | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 31 Mar 2014 | The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic,… | GE OEC Medical Systems, Inc | Device | Class II | 1 |
| 28 Mar 2014 | GLOBAL Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulated reamer(s) and cannulated central drills in… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 28 Mar 2014 | Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431 | Terumo Cardiovascular Systems Corp | Device | Class II | 1 |
| 28 Mar 2014 | i heart keenwah Chocolate Sea Salt All Natural Quinoa Clusters. UPC 736211802446 for the 4 oz UPC 713757598101 for the 1 oz | keen-wah LLC | Food | Class II | 5 |
| 27 Mar 2014 | Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 27 Mar 2014 | Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less. Event 67876 | Central Purchasing LLC DBA Harbor Freight Tools | Device | Class II | 1 |
| 27 Mar 2014 | GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging. | GE Healthcare, LLC | Device | Class II | 1 |
| 27 Mar 2014 | Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer… | Boehringer Ingelheim Roxane Inc | Drug | Class III | 1 |
| 27 Mar 2014 | Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA | Hospira Inc. | Drug | Class II | 1 |
| 27 Mar 2014 | Luna Chocolate Chunk; Whole Nutrition Bar for Women; 15 count box. Clif Bar & Company, Emeryville, CA | Clif Bar And Company | Food | Class II | 1 |
| 26 Mar 2014 | ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only. Event 67818 | Branan Medical Corporation | Device | Class II | 1 |
| 26 Mar 2014 | Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 26 Mar 2014 | Herring Fillets in Wine Sauce sold under the ELF brand in 12 oz. plastic jars. | Vita Food Products, Inc. | Food | Class I | 1 |
| 26 Mar 2014 | Creative Snacks Co. Dried Apricots (10.5 oz Rigid Plastic Cup, and 7 oz Clear Plastic Bag), Distributed by: Creative Snacks, Co., Greensboro, NC 27409 | Creative Snacks Co., LLC | Food | Class I | 1 |
| 25 Mar 2014 | Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during… | Draeger Medical, Inc. | Device | Class II | 1 |
| 25 Mar 2014 | Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment. | Ormco/Sybronendo | Device | Class II | 1 |
| 25 Mar 2014 | Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment. | Ormco/Sybronendo | Device | Class II | 1 |
| 25 Mar 2014 | Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL. | Hospira Inc. | Drug | Class III | 1 |
| 25 Mar 2014 | OPTIMUM E-1000 IU Gluten Free Dietary Supplement 100 SOFTGELS Product is packaged in a white HDPE bottle with foil cap under the white plastic cap. Bottle contains 100 softgel caps. UPC 0 43292 56291 7. Event 67915 | Magno Humphries Laboratories, Inc | Food | Class II | 1 |
| 24 Mar 2014 | Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter. | Arrow International Inc | Device | Class II | 1 |
| 24 Mar 2014 | Orton Bros. Brand Zesty Lemon Cookie Buttons; 6 oz. yellow box, UPC code 20104 19100. The lot code and expiration date are stamped on the bottom of the box; LOT14021M with the expiration date of 10-21-14. Event 67816 | Vermont Common Foods, LLC | Food | Class I | 1 |
| 21 Mar 2014 | Kellogg's Eggo Buttermilk au babeurre waffles 280g 8ct, UPC 0 64100 23817 6 Ingredients/ Ingredients: Water, Wheat Flour, soybean and palm oil shortening, whole egg, baking powder, sugar, salt milk ingredients, hydrogenated soybean oil, soy lecithin Contains wheat, egg, milk and soy ingredients .... Imported by /… | Kellogg Company | Food | Class II | 1 |
| 21 Mar 2014 | 2521 Cherry Glaze Pop (Flavoring for popcorn) - Paperboard Carton | Gold Medal Products | Food | Class II | 4 |
| 21 Mar 2014 | Peanut Butter sold under the following sizes, brands, and textures: 1. 16 oz tubs with snap on lid (12 tubs in box) Parkers Farm CREAMY (55100) 2. 34 oz. tubs with snap on lid (6 tubs in box) Parkers Farm CREAMY (55300) 3. 5 lb. pail (2 pails in box) Parkers Farm Creamy (55105) 4. 34 oz. tubs with snap on lid (8 tubs… | Parkers Farm Inc | Food | Class I | 40 |
| 20 Mar 2014 | On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks. | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 20 Mar 2014 | FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures. | Solta Medical, Inc. | Device | Class II | 1 |
| 20 Mar 2014 | 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage | Aspen Surgical Products, Inc. | Device | Class II | 19 |
| 20 Mar 2014 | "Honey Roasted Peanuts Golden Roast" sold under the Fisher brand and packaged in 14 oz. plastic jars. | John B. Sanfilippo & Son Inc. | Food | Class II | 1 |
| 19 Mar 2014 | SmartSite Extension Set, Model No. 20029E, intravascular administration set. | CareFusion 303, Inc. | Device | Class II | 1 |
| 19 Mar 2014 | Strawberry Fruit Bar, 3 oz., Helados La Tapatia Fresno, CA 93706 | Helados La Tapatia, Inc | Food | Class II | 53 |
| 18 Mar 2014 | Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the package. Event 67597 | Energizer Personal Care | Device | Class II | 1 |
| 18 Mar 2014 | Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05. | Glenmark Generics Inc., USA | Drug | Class II | 1 |
| 17 Mar 2014 | 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY. | 3M Company - Health Care Business | Device | Class II | 1 |
| 17 Mar 2014 | Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions | Smiths Medical ASD, Inc. | Device | Class II | 2 |
| 17 Mar 2014 | Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England. | Remel Inc | Device | Class II | 2 |
| 17 Mar 2014 | Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85 | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 17 Mar 2014 | Macaroni and cheese packaged in plastic bags, 12 oz. to a bag, and sold under the Sweet Street Desserts brand. Cases of product contain 36 bags for a total case weight of 27 lbs. Event 67794 | Name withheld | Food | Class I | 1 |
| 17 Mar 2014 | Cinnamon Cookie Manjoo, 200g Net Weight. Packaged in clear plastic bag, 10 per bag. Product package labeled in part:"***Cinnamon Cookie (Manjoo)*** Net Wt. 200g, 7.1oz***Manufactured by: CJ Foodville USA, Inc. (323)480-9105***6834 E. Slauson Ave, Commerce, CA 90040***2229039219***. | CJ Bakery, INC | Food | Class II | 3 |
| 17 Mar 2014 | Simply Lite brand 50% CaCao Low Carb Sugar Free Dark Chocolate (NET WT 3 oz (85g), packaged in a brown plastic foil wrapper. Produced by Simply Natural Foods, LLC. 74 Mall Drive Commack, New York 11725. Event 67742 | Simply Natural Foods LLC | Food | Class I | 1 |
| 14 Mar 2014 | Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation. Event 67755 | Alcon LenSx, Inc. | Device | Class II | 1 |
| 14 Mar 2014 | Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support. | Breg Inc | Device | Class II | 2 |
| 14 Mar 2014 | VPRIV (velaglucerase alfa for injection), Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04. Event 67690 | Shire Human Genetic Therapies, Inc. | Drug | Class I | 1 |
| 14 Mar 2014 | Fannie May Assorted Chocolates Rich dark & milk chocolate & pastels with an assortment of decadent fillings NET WT 14 OZ (396 g) Assorted Chocolates Nutrition Facts:***Ingredients: SUGAR, MILK CHOC LATES***CONTAINS: EGGS, MILK, SOY, TREE NUTS. WHEAT, GLUTEN***Distributed By: Fannie May Confections Brands, Inc.,… Event 67756 | Fannie May Confection Brands Inc | Food | Class I | 1 |
| 14 Mar 2014 | Enhanced Bali Leaf Powder, Max Kratom, Capsule, UPC Code 5410600332, 20 count pack, 5 servings per pack, Herbal Dietary Supplement. | Smiley National Inc | Food | Class II | 4 |
| 13 Mar 2014 | Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 13 Mar 2014 | 5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in… | Intuitive Surgical, Inc. | Device | Class II | 4 |
| 13 Mar 2014 | Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer. | Merit Medical Systems, Inc. | Device | Class II | 2 |
| 13 Mar 2014 | Italian blend Salad (Romaine Lettuce and Radicchio) packaged under the following brand names: Dole Italian Blend, (UPC 7143000819); Fresh Selections Italian Style Blend (Kroger) (UPC 1111091045); Little Salad Bar Italian Salad, (UPC 4149811014); Marketside Italian Style Salad, (Wal Mart) (UPC 8113102780) 10 oz. bags… | Dole Fresh Vegetables Inc | Food | Class I | 1 |
| 11 Mar 2014 | Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5. | Teleflex Medical | Device | Class II | 1 |
| 11 Mar 2014 | Weck Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. | Teleflex Medical | Device | Class II | 15 |
| 11 Mar 2014 | Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48 | Teleflex Medical | Device | Class II | 1 |
| 11 Mar 2014 | Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. | Teleflex Medical | Device | Class II | 6 |
| 11 Mar 2014 | Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. An endoscope and accessories is a device used to provide access,… | Teleflex Medical | Device | Class II | 6 |
| 11 Mar 2014 | Hard Blast Pink Lemonade Net Wt. 19 oz. Developed and exclusively distributed by: TBI Labs LLC, Miami, FL 33137 www.tbilabs.com 888-253-0958 Made in USA UPC 628586182561 | Command Nutritionals, LLC | Food | Class II | 2 |
| 11 Mar 2014 | Sausage & Egg English Muffin, Good and Fresh brand, 4.1 oz, packaged in clear plastic wrap. UPC 855173005204. | Flying Food Group LLC | Food | Class II | 1 |
| 10 Mar 2014 | SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator. | Del Mar Reynolds Medical, Ltd. | Device | Class I | 1 |
| 10 Mar 2014 | Cookin' Cajun (TM) Acadiana Style Etouffee Seasoning Blend, UPC 898851004 Event 67759 | Creole Delicacies Kitchens Inc | Food | Class II | 1 |
| 8 Mar 2014 | Kirkland Signature brand Real Sliced Fruit, Item # 527069. The UPC on the master cardboard case is 0 96619 52706 9. Each cardboard case consists of 20 plastic pouches (7.41 oz): 10 pouches of Fuji Apple Slices, 5 pouches of Strawberry Banana Slices, and 5 pouches of Fuji Apple Slices with Cinnamon. The UPC on Fuji… Event 67728 | Oregon Freeze Dry Inc | Food | Class I | 1 |
| 8 Mar 2014 | Wing Bran-Bkrs 40# 30/PAL720600, #14535 , Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72060 5, Ingredients Wheat Bran. Wingold Bran - Bakers 40#720500, Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72050 6, Ingredients What Bran. Event 67760 | Bay State Milling Company | Food | Class II | 1 |
| 7 Mar 2014 | Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 6 Mar 2014 | Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 6 Mar 2014 | ZYM B Reagent (REF 70493). The ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms. | BioMerieux SA | Device | Class II | 4 |
| 5 Mar 2014 | Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System. | Pega Medical Inc. | Device | Class II | 1 |
| 5 Mar 2014 | Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator. | ZOLL Medical Corporation | Device | Class II | 1 |
| 5 Mar 2014 | MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 5 Mar 2014 | AXIOM Vertix MD Trauma systems radiographic X-ray | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 5 Mar 2014 | VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 5 Mar 2014 | Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833 | Draeger Medical Systems, Inc. | Device | Class I | 1 |
| 5 Mar 2014 | FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device. | Remington Medical Inc. | Device | Class II | 1 |
| 4 Mar 2014 | HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. | Thoratec Corporation | Device | Class I | 4 |
| 4 Mar 2014 | Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tube and accessories, consisting of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. | Teleflex Medical | Device | Class II | 1 |
| 4 Mar 2014 | Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054 | LumiQuick Diagnostics Inc. | Device | Class II | 80 |
| 4 Mar 2014 | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06 | Teva Pharmaceuticals USA | Drug | Class II | 3 |
| 4 Mar 2014 | Belmont Premium Ice Cream, Chocolate Chip Cookie Dough, All Natural, 1.5 Quarts (1.42 L), Nutrition Facts....., Ingredients: Skim milk, Cream, Sugar, Cookie dough pieces (unenriched wheat flour, sugar, butter (cream, salt), brown sugar, water, corn oil, fructose, corn syrup solids, salt, vanilla extract, sodium… | House Of Flavors, Inc. | Food | Class I | 1 |
| 4 Mar 2014 | Graeter's Ice Cream Big Scoop COOKIES AND CREAM Ingredients: cream, milk, cane sugar***locust bean gum. Manufactured Under Authority of Graeter's Inc., 1175 Regina Graeter Way Cincinnati, Ohio 45216 022715" Event 67931 | Tedesco LLC | Food | Class II | 1 |
| 4 Mar 2014 | Stage 2 World Baby Thailand; Roasted Pumpkin & Coconut Rice, 3.5 oz. pouch. Product of USA distributed by Plum Inc., Emeryville, CA | Plum Inc | Food | Class II | 2 |
| 3 Mar 2014 | FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli… | Medtronic Vascular, Inc. | Device | Class II | 3 |
| 3 Mar 2014 | Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into… | Biocardia, Inc. | Device | Class II | 2 |
| 3 Mar 2014 | Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05 | Novartis Pharmaceuticals Corp. | Drug | Class III | 2 |
| 3 Mar 2014 | Pleo Not OINTMENT 3X, 30 g Tube, Topical Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2305-1. | Terra-Medica Inc. | Drug | Class II | 22 |
| 3 Mar 2014 | 8 oz. Tuscan Style Combo on Tomato Basil Spread sandwiches individually wrapped in clear plastic wrap sold under the Fresh To Go brand. Event 67662 | Name withheld | Food | Class I | 1 |
| 28 Feb 2014 | Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6>Roche OMNI S6 system 4. 03337138001, cobas b… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 28 Feb 2014 | Popsicle Orange Cherry Grape 20 pops Net 33 fl oz Unilever Englewood Cliffs, NJ 07632 USA UPC 077567121301 | Unilever United States, Inc. | Food | Class I | 1 |
| 28 Feb 2014 | UNCLE BEN's(R) READY RICE(R) Original Enriched Long Grain White Rice, 8.8 oz. (250g), UPC 054800 031764 | Mars Food US | Food | Class II | 1 |
| 28 Feb 2014 | Diced Dry Bean Curd. Manufactured by: E Won Trading Company, LTD. Distributed by: Win Luck Trading Co. LLC, 100 Pulaski Street, Bayonne, NJ 07002. UPC 4716670715248. 10.58 oz (300g) plastic bag. Event 67878 | Lam Sheng Kee (Usa) Enterprise C | Food | Class II | 1 |
| 27 Feb 2014 | D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution,… | Bio-Rad Laboratories, Inc. | Device | Class II | 1 |
| 27 Feb 2014 | Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to… | Trivascular, Inc | Device | Class II | 1 |
| 27 Feb 2014 | PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070 | Bard Access Systems | Device | Class II | 1 |
| 26 Feb 2014 | my essentials brand sour cream, NET WT. 24 OZ. (680g), UPC 7 25439 10546 0 --- Firm on label: DISTRIBUTED BY DZA BRANDS, LLC 2110 Executive Drive, Salisbury, NC 28147 --- The sour cream is packed in a plastic container. | HP Hood LLC | Food | Class II | 1 |
| 26 Feb 2014 | Frozen Ice Cake (Watermelon), 17.98 oz, 6 retail units/carton, UPC 8 801062 443055 Event 67634 | JIN SUN MI INTERNATIONAL INC | Food | Class I | 1 |
| 25 Feb 2014 | LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers. | Hospira Inc. | Device | Class II | 1 |
| 24 Feb 2014 | AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern. Event 67647 | Name withheld | Device | Class II | 1 |
| 24 Feb 2014 | vitacost brand L-Citrulline Amino Acid 750 mg, 90 CAPSULES, DIETARY SUPPLEMENT, ITEM # NSI 3003310, UPC 8 35003 00331 0 --- Manufactured for Vitacost Lexington, NC 27295 | Nature's Value Inc. | Food | Class II | 2 |
| 24 Feb 2014 | Net Food Turkey Dried Apricots Net Weight 16.1 oz (454 g) Thunderbolt Export & Imports 743 Fairview Avenue. Suit :2 Arcadia, CA 91007 USA UPC 8697445250019 Event 67681 | Net Food Import and Export llc. | Food | Class I | 1 |
| 24 Feb 2014 | L-Citrulline, bulk product, 25 kg Event 67616 | Name withheld | Food | Class I | 1 |
| 21 Feb 2014 | Poor Boy Sandwich, 7oz. Product labeling reads in part:"POOR BOY SANDWICH***Perishable Keep Refrigerated***Net Wt. 7 oz***Mrs. Riggs Sandwiches 1792 Callens Rd Ventura CA 93003***" | Name withheld | Food | Class II | 2 |
| 20 Feb 2014 | Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03… | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Drug | Class III | 10 |
| 20 Feb 2014 | Ideal Protein Double Chocolate Brownie. Individually wrapped, sold in boxes of 7. Event 67649 | Laboratories Cop Inc | Food | Class II | 1 |
| 20 Feb 2014 | Asian Taste (Brand) Green Tea Pumpkin Seeds, 8 oz., UPC 673367418186. | Walong Marketing, Inc. | Food | Class III | 1 |
| 20 Feb 2014 | FAIRWAY brand CONDIMENT GRILLING SAUCE, NET WT 12 oz (340 g), UPC 7 58940 70609 3 -- Distributed By: Fairway Group Central Services LLC New York, New York 10027 --- The product is packaged in a glass bottle, 12 bottles per case. Event 67600 | Wolfgang B. Gourmet Foods, Inc. | Food | Class II | 1 |
| 19 Feb 2014 | Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. | Ethicon, Inc. | Device | Class II | 1 |
| 19 Feb 2014 | Tom Yom Soup, 24 oz. plastic cups, packed 6 cups\cardboard case, and labeled in part ***Manufactured by Whole Foods Market, Landover, MD 20785***UPC 00000601467*** Event 67577 | Whole Foods Market Mid-Atlantic Kitchen | Food | Class I | 1 |
| 19 Feb 2014 | Requeson Mexicana Part-Skim Ricotta, 15 oz., packaged in a plastic cup, Distributed by Roos Foods Inc., Kenton, DE 19955, UPC code 095548003415, (Ingredients: Pasteurized milk, whey, skim milk, cultured milk, solids, carrageenan, salt, potassium sorbate, (preservative)) . Requeson Mexicana Part-Skim Ricotta, 16 oz.… | Roos Foods Inc | Food | Class I | 18 |
| 18 Feb 2014 | Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP)… | Lin-Zhi International Inc | Device | Class III | 1 |
| 17 Feb 2014 | TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS). Event 67628 | Name withheld | Device | Class III | 1 |
| 14 Feb 2014 | Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers. | Spacelabs Healthcare, Llc | Device | Class II | 1 |
| 14 Feb 2014 | RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 14 Feb 2014 | etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-03), Rx only, Distributed by Pfizer… Event 67580 | Agila Specialties Private Ltd. | Drug | Class II | 1 |
| 13 Feb 2014 | MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 13 Feb 2014 | The Other Macaroon G'nache P'nache 5.3 oz. Manufactured and Distributed by:Northern Valley Baking Co LLC, Dumont, New Jersey USA Event 67737 | Northern Valley Baking Co. | Food | Class II | 1 |
| 11 Feb 2014 | The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures. | Synthes, Inc. | Device | Class II | 1 |
| 11 Feb 2014 | Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. | Philips Medical Systems (Cleveland), Inc. | Device | Class II | 1 |
| 11 Feb 2014 | AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum. | AMS Diagnostics, LLC | Device | Class II | 3 |
| 11 Feb 2014 | Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only. Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13 Event 67606 | Viiv Healthcare Company | Drug | Class III | 1 |
| 11 Feb 2014 | QVAR (beclomethasone dipropionate HFA), C4 INHALATION AEROSOL in Aluminum Cylinders, Mktd by: Teva Respiratory, LLC, Horsham, PA 19044 Mfd by: 3M Drug Delivery Systems, Northridge, CA 91324. | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 11 Feb 2014 | Mrs. Griffin's Hot Barbecue Sauce, Net 1 Gallon (13.785L), Made by Griffin Barbecue Sauce, Inc., Macon GA 31206 | Name withheld | Food | Class I | 3 |
| 7 Feb 2014 | Artis Zee Angiographic x-ray systems. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 7 Feb 2014 | SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of… | Baxter Healthcare Corp. | Device | Class I | 1 |
| 7 Feb 2014 | AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 7 Feb 2014 | Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital. | Draeger Medical Systems, Inc. | Device | Class I | 1 |
| 7 Feb 2014 | Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod. | Pega Medical Inc. | Device | Class II | 1 |
| 7 Feb 2014 | Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets,… | Ohm Laboratories, Inc. | Drug | Class II | 1 |
| 7 Feb 2014 | Evolution fresh Organic sweet Greens and Ginger, 15.2 fluid-ounce bottle, 6 bottles/case, UPC code is 762357378927. Event 67488 | Evolution Fresh Inc | Food | Class III | 1 |
| 6 Feb 2014 | RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 6 Feb 2014 | RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 4 Feb 2014 | Evropa Zele Bonboni Jelly Candy Net Wt. 500 g Imported in USA by: Fast-Pak Trading Inc., 375 County Ave., Secaucus, NJ 07094 UPC 5310002480041 Event 67629 | Fast-Pak Trading Inc. | Food | Class III | 1 |
| 3 Feb 2014 | IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an… | Siemens Medical Solutions Diagnostics | Device | Class II | 1 |
| 3 Feb 2014 | Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 3 Feb 2014 | Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure. | Altasource LLC dba Meta Labs LLC | Device | Class II | 4 |
| 31 Jan 2014 | HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01 | American Health Packaging | Drug | Class II | 2 |
| 31 Jan 2014 | DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20 | Hill Dermaceuticals, Inc. | Drug | Class III | 9 |
| 31 Jan 2014 | New Horizon Cuisine Chicken Demi-Glace Xpress, packaged in 16-oz. plastic cups (6/case) and New Horizon Cuisine Chicken Demi-Glace packaged in 16-lb. (2-gal.) buckets. The firm name on the label is New Horizon Cuisine, Ankeny, IA. Event 67397 | New Horizon Cuisine | Food | Class III | 1 |
| 30 Jan 2014 | Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion. | Synthes, Inc. | Device | Class II | 1 |
| 29 Jan 2014 | VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD ---… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 27 Jan 2014 | Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02. | Lupin Pharmaceuticals Inc. | Drug | Class III | 2 |
| 27 Jan 2014 | Golden Natural Fruit Island Net Wt. 25.00 oz Product of Crown Food North Bergen, NJ 07047 Packed by: Crown Food/North Bergen 07047 USA UPC 098346021032 Event 67671 | Crown Food Distributors Inc | Food | Class I | 1 |
| 24 Jan 2014 | Bonduelle USA Inc (Oakfield) BEANS GREEN CUT GRADED, Net weight: 1,480 lbs (bulk form in Totes), Keep frozen. | Bonduelle USA Inc | Food | Class III | 2 |
| 23 Jan 2014 | Chicken Soup for the Soul Thai-Style Chicken Broth, 32 oz. (2 lb., 907 g. paperboard carton. Distributed by Chicken Soup For The Soul Foods, LLC, Stamford, CT 06902-7532 UPC: 8 19239 01021 2. Event 67369 | Chicken Soup For The Soul Food | Food | Class II | 1 |
| 20 Jan 2014 | Winn-Dixie Chocolate Flavored Drink Mix NET WT 30 OZ (1 LB 14 OZ) 851 G Distributed by: Winn-Dixie Stores, Jacksonville, FL 32254 Event 67361 | Winn-Dixie Logistics, Inc. | Food | Class I | 1 |
| 14 Jan 2014 | St. Mary's River Smokehouses Oven Smoked Atlantic Salmon Stix, Chili Mango Flavor Event 67341 | Delhaize America (Hannaford Bros) | Food | Class I | 1 |
| 13 Jan 2014 | Kinnikinnick Original Homestyle Waffles 210 g/7.4 oz Cardboard Box UPC 620133001981 | World Pure Foods Wholesalers, Inc. | Food | Class I | 3 |
| 7 Jan 2014 | Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. | Synthes, Inc. | Device | Class II | 1 |
| 6 Jan 2014 | Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring. Event 67582 | Infantino LLC | Device | Class II | 1 |
| 1 Jan 2014 | i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances. | Abbott Point Of Care Inc. | Device | Class II | 1 |
| 31 Dec 2013 | Prego Italian Sauce Traditional, NET WT. 24 OZ (1 LB. 80 Z.)(680 g) in glass jars. | Campbell Soup Supply Co., LLC | Food | Class II | 1 |
| 31 Dec 2013 | Peanut Butter Cookies | Butter Creek Farms, Inc. | Food | Class I | 11 |
| 19 Dec 2013 | Thickened Water Pudding Thick 32 oz. (944ml) Phase 3 Ingredients: Pasteurized Filtered Water, Cellulose Gum Fibre, Potassium Sorbate. | Nutra Balance Products | Food | Class II | 2 |
| 13 Dec 2013 | CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve… | Codman & Shurtleff, Inc. | Device | Class II | 1 |
| 12 Dec 2013 | Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205. | Zions RX Formulations Services LLC dba RX Formuations Serv. | Drug | Class I | 7 |
| 10 Dec 2013 | Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Domestica 50 mg, Propetary Blend 300 mg Cynara Scolymus, Hoodia, Siruline, Chitosan, 60-count bottles, Distributed by Natural Products, Doral, FL 33178. | Slim Beauty USA | Drug | Class I | 3 |
| 9 Dec 2013 | Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for… | Gambro Renal Products, Incorporated | Device | Class II | 1 |
| 6 Dec 2013 | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and… | HeartWare Inc | Device | Class I | 1 |
| 5 Dec 2013 | Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 4 Dec 2013 | Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy | Ion Beam Applications S.A. | Device | Class II | 1 |
| 18 Nov 2013 | Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264 | Brainlab AG | Device | Class II | 1 |
| 18 Nov 2013 | RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309 Event 66878 | Fossil Fuel Products, LLC | Drug | Class I | 1 |
| 13 Nov 2013 | Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045. Event 67026 | Brookfield Prescription Center Inc | Drug | Class I | 1 |
| 7 Oct 2013 | Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules. | B @ B Trade Inc. | Drug | Class I | 3 |
| 27 Sep 2013 | Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles Made in the USA Distributed by: Prolifta LLC 1+877.239.8231 www.proliftaherbal.com. | Haute Health, LLC | Drug | Class I | 3 |
| 16 Sep 2013 | 1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045. | Hospira, Inc. | Drug | Class I | 1 |
| 29 Aug 2013 | BIOMET 3i Endosseous Dental Implant. | Biomet 3i, LLC | Device | Class II | 1 |
| 25 Jul 2013 | DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating,… Event 67615 | Velocity Medical Solutions, LLC | Device | Class II | 1 |
| 17 Jul 2013 | Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC. | Arrow International Inc | Device | Class II | 1 |
| 20 May 2013 | JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle | Dolphin Intertrade Corporation | Drug | Class I | 2 |
| 10 May 2013 | 400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients. Event 67804 | ErgoSafe Product LLC dba Prism Medical Services | Device | Class II | 1 |
| 30 Apr 2013 | Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com. | American Lifestyle.Com | Drug | Class I | 2 |
| 28 Mar 2013 | The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite… Event 64791 | Name withheld | Device | Class III | 1 |
| 28 Mar 2013 | Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. | Elekta, Inc. | Device | Class II | 1 |
| 24 Feb 2013 | Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. | Clinical Diagnostic Solutions | Device | Class II | 1 |