| 12 Feb 2014 | CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO… | Biosense Webster, Inc. | Device | Class II | 1 |
| 7 Feb 2014 | MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other… Event 67492 | Biocardia, Inc. | Device | Class II | 1 |
| 4 Feb 2014 | Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121. | Boston Scientific Corporation | Device | Class II | 2 |
| 30 Jan 2014 | Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips.… | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 6 |
| 30 Jan 2014 | Mid Pac Foods brand sauce for Char Sui; Net 7 FL. oz (207 ml); Made in Hawaii, Keep in cool place UPC: 7336620250 Manufactured by Mid Pac Foods, Inc. Honolulu, HI. Event 67422 | Mid Pac Foods, Inc. | Food | Class II | 1 |
| 30 Jan 2014 | Mega Slim Herbal Appetite Management, 30 Capsules Bottle. Product labeling reads in part:"MEGASLIM Herbal Appetite Management***30 Capsules***YoungYou Weight Loss Center***MegaSim Propriety Blend 590 mg, Garcinia Cambogia Extract, Green Tea, Aloe Ferox, L-Carnitine, Caralluma fimbriata Extract***Distributed by… Event 67402 | YoungYou International Inc | Food | Class II | 1 |
| 29 Jan 2014 | Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary. Event 67446 | Implantech Associates Inc | Device | Class II | 1 |
| 29 Jan 2014 | Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100… | Caraco Pharmaceutical Laboratories Ltd. | Drug | Class II | 1 |
| 29 Jan 2014 | Gano C'Real Spirulina, Net Wt. 450g (30gx15 sachets) Event 67389 | Gano Excel USA Inc | Food | Class I | 1 |
| 27 Jan 2014 | Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral. | Synthes, Inc. | Device | Class II | 1 |
| 27 Jan 2014 | Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible. | Synthes, Inc. | Device | Class II | 1 |
| 27 Jan 2014 | Pringles, the Original, Net Weight 5.68 oz (161 g) UPC code 0 38000 84496 6 Ingredients: INGREDIENTS: DRIED POTATOES, VEGETABLE OIL (CONTAINS ONE OR MORE OF THE FOLLOWING: CORN OIL, COTTONSEED OIL, SOYBEAN OIL, AND/OR SUNFLOWER OIL), CORN FLOUR, WHEAT STARCH, MALTODEXTRIN, SALT, RICE FLOUR AND DEXTROSE. CONTAINS… | Kellogg Company | Food | Class I | 1 |
| 24 Jan 2014 | Gorgonzola Gems Jalapeno Peppers With Gorgonzola and Cream Cheese Blend 8 oz. (227 g) packages, 6/pack Event 67383 | Windsor Frozen Foods | Food | Class II | 1 |
| 24 Jan 2014 | IQF Stuffed Brined Jalapeno Peppers w/Gorgonzola Allergen: Milk, Wheat. Prod.Code: 4013 24/30 lb bags - 720 lb totes Keep Frozen Bin# Comarco Products 501 Jackson Street, Camden, NJ 08104 Event 67480 | Comarco Products, Inc. | Food | Class II | 1 |
| 23 Jan 2014 | Lenguita Cookies net wt. 6 oz., Distributed by Mama Lycha Foods, Houston TX 77055 toll free (877)MAMALYCHA email contact@mamalycha.com www.mamalycha.com Product of Honduras Event 67371 | Gotera, Inc | Food | Class II | 1 |
| 23 Jan 2014 | Gourmet Bar in the following flavors: bacon, cayenne pepper, crispy orange, curry, mendiant dark, mendiant light Araya Artisan Chocolate: 1545 W Grand Parkway S, Katy, TX, 77494 Tlf (281) 395-1050 info@arayachocolate.com | Araya, Inc | Food | Class II | 5 |
| 22 Jan 2014 | Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 22 Jan 2014 | SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle. | CareFusion 303, Inc. | Device | Class II | 1 |
| 20 Jan 2014 | Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation. | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 20 Jan 2014 | Dried Tapioca Pearl, Net Wt. 7oz, 50 bags/carton, UPC Code 0893467803068 Event 67327 | New Japan International, Inc. | Food | Class II | 1 |
| 18 Jan 2014 | Farm To Market Bread Co. San Francisco Sourdough, net weight 1 lb., unbleached enriched flour, water, sea salt, vitamin C. Farm to Market Bread Co., Kansas City, MO. Event 67321 | Farm To Market Bread Co Inc | Food | Class II | 1 |
| 17 Jan 2014 | Panko Style Bread Crumbs net wt. 350g 12.5 oz. gluten free, dairy free, nut free Event 67379 | Braum's Ice Cream and Dairy | Food | Class I | 1 |
| 17 Jan 2014 | Kinnikinnick Original Homestyle Waffles Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box UPC: 62013300198 1 Event 67316 | Cal-Fresh Produce | Food | Class I | 1 |
| 17 Jan 2014 | STEMALIVE, 90 Capsules. The product is in a white plastic bottle with white lid, the brand is StemVida International with a white and gold label. Product labeling reads in part:"STEMVIDA INTERNATIONAL***StemAlive***PROMOTES ADULT STEM CELL FUNCTION AND HEALTH***Dietary Supplement***90 Capsules***Formulated… Event 67295 | STEMVIDA INTERNATIONAL INC | Food | Class I | 1 |
| 16 Jan 2014 | LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or… Event 67315 | Zest Anchors LLC | Device | Class II | 1 |
| 16 Jan 2014 | Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230. | CareFusion 303, Inc. | Device | Class II | 1 |
| 16 Jan 2014 | ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam. | The Mentholatum Co. | Drug | Class II | 5 |
| 16 Jan 2014 | NatureBox Picante Ranch Mix Spicy Snack Mix with Corn Nuts and Masa Chips; Net. WT: 4 oz. (113 g), Stand up Pouch, Vegan Ingredients: Corn Nuts (corn, canola oil, soybean oil, salt), Sugar, Flax Chips (Yellow corn masa, flax seeds, soybean oil, salt) Snack Seasoning(sour cream, salt, whey, corn syrup, tomato,… | NatureBox, Inc. | Food | Class II | 2 |
| 15 Jan 2014 | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01. | Watson Laboratories Inc | Drug | Class II | 1 |
| 15 Jan 2014 | Cactus Leaves/pads ("Nopales"), 40 lbs Event 67281 | Marquez Produce Inc. | Food | Class II | 1 |
| 14 Jan 2014 | Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01 | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 14 Jan 2014 | PASKESZ PREMIUM BELGIAN CHOCOLATE, KOSHER PARVE, Holographic Coins, Net Wt. 0.5 oz (14g) packaged in a carton containing 12 boxes with each box containing 24 mesh bags x 0.5 oz (14g) total weight 12 oz (336g), each mesh bag contains 5 pieces, ITEM 30178. MADE IN HOLLAND FOR: PASKESZ CANDY CO., Inc. Brooklyn, NY 11232. Event 67274 | Paskesz Candy Co.,Inc. | Food | Class I | 1 |
| 13 Jan 2014 | Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy. | Accuray Incorporated | Device | Class II | 1 |
| 13 Jan 2014 | InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908 | Philips Healthcare | Device | Class II | 1 |
| 13 Jan 2014 | Panko Style Bread Crumbs, 12.5 oz, UPC 620133600153, NB Item #636886 | Natures Best Inc | Food | Class I | 5 |
| 13 Jan 2014 | Kinnikinnick Gluten Free Bread Crumbs Panko Style - gluten free, dairy free, nut free. 350g/12.5oz. UPC 62013360015 3 2 | Unified Western Grocers Inc | Food | Class I | 4 |
| 13 Jan 2014 | Kinnikinnick Gluten Free Original Homestyle Waffles Frozen Contains a logos on the package indicating it is gluten free, dairy free, and nut free. 210 g/7.4oz Qty/pkg - 6. UPC 62013300198 1. DPI item # 55844. Event 67294 | DPI Specialty Foods Northwest Inc. | Food | Class I | 1 |
| 10 Jan 2014 | T:slim Insulin Delivery System Insulin Infusion Pump | Tandem Diabetes Care Inc | Device | Class I | 1 |
| 10 Jan 2014 | Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in… | Focus Diagnostics Inc | Device | Class II | 1 |
| 9 Jan 2014 | Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses. | Medtronic Cardiovascular Surgery-the Heart Valve Division | Device | Class II | 1 |
| 9 Jan 2014 | Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05 | Hospira Inc. | Drug | Class II | 2 |
| 9 Jan 2014 | Monarch Breakfast Syrup, in 1.5 oz. portion control cups, Distributed by US Foods, Inc., Rosemont, IL 60018. Event 67301 | Sauer Company The C F | Food | Class I | 1 |
| 8 Jan 2014 | SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. | B. Braun Medical, Inc. | Device | Class II | 1 |
| 8 Jan 2014 | IMPAX RIS QDOC 5.8 | AGFA Corp. | Device | Class II | 1 |
| 8 Jan 2014 | 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system. | OrthoPediatrics Corp | Device | Class II | 1 |
| 8 Jan 2014 | Cactus Pads (Nopal) Mexpogroup: Product of Mexico Event 67296 | Washington Vegetable Co | Food | Class III | 1 |
| 7 Jan 2014 | Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows. | Synthes, Inc. | Device | Class II | 1 |
| 7 Jan 2014 | Simply balanced, herb mixed freeze dried vegetables all natural, Ingredients: Super sweet corn, edamame, peas, carrots, (carrots, sugar, dextrose, tapioca starch), Italian seasoning (Garlic, tomato (tomato, salt), crushed red pepper, basil, oregano), coconut oil, sea salt. May contain peanut, tree nuts, milk, soy,… | American Importing Co, Inc | Food | Class II | 1 |
| 6 Jan 2014 | Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 6 Jan 2014 | Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035” guidewire. | Boston Scientific Corporation | Device | Class II | 1 |
| 6 Jan 2014 | Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227. | Zimmer Dental Inc | Device | Class II | 1 |
| 3 Jan 2014 | SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument. | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 3 Jan 2014 | Marlyce's Homemade Butterballs Event 67277 | L. M. Noodle Company, LLC | Food | Class I | 1 |
| 2 Jan 2014 | Condies Food fine shred lettuce, and 1/4 shred lettuce; 5 lbs bags, 4 bags per case | Condies Foods, Inc | Food | Class II | 1 |
| 30 Dec 2013 | Neptune 2 Rover Ultra Waste Management System. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 2 |
| 27 Dec 2013 | GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal… | GE Healthcare, LLC | Device | Class II | 1 |
| 27 Dec 2013 | The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series… | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 27 Dec 2013 | BACA'S GC Hot 12-13oz Z, Product Item Number 1010-0. Packaged in plastic containers. All packed in cardboard shipper box that is then sealed with attached shipper label. Total package size of 12 units of 13 oz each per case totaling 9.75 lbs. | El Encanto, Incorporated | Food | Class II | 39 |
| 27 Dec 2013 | Uncle Ben's (R), Infused(R) Rice Mexican Flavor rice, NET WT 5 LB (2.27 kg), distributed by MARS Foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059 | Mars Food US | Food | Class II | 1 |
| 26 Dec 2013 | KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A. | Carestream Health, Inc. | Device | Class II | 1 |
| 23 Dec 2013 | Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. | Aesculap, Inc. | Device | Class II | 1 |
| 23 Dec 2013 | Horizon Medical Imaging, Picture Archive Communication System (PACS). | Mckesson Information Solutions LLC | Device | Class II | 1 |
| 23 Dec 2013 | Aztec Cheddar Cheese; Packaged in clear plastic in sizes ranging from 1/2 lb to whole wheels (approximately 13 lbs). Labeled in part: "367 BISHOP CHAPEL CHURCH RD SWAINSBORO, GA 30401***FLAT CREEK LODGE AZTEC CHEDDAR Raw milk, salt,***130823XCAZ" | Flat Creek Farm & Dairy | Food | Class I | 2 |
| 22 Dec 2013 | ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pediatric, Transesophageal, Adult Cephalic,… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 22 Dec 2013 | ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 20 Dec 2013 | Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump. Event 67154 | Perrigo Diabetes Care | Device | Class II | 1 |
| 20 Dec 2013 | CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system… | GE Healthcare, LLC | Device | Class II | 1 |
| 20 Dec 2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6. Event 67259 | Watson Laboratories, Inc.-(Actavis) - Florida | Drug | Class II | 1 |
| 20 Dec 2013 | Walmart Great Value Tex Mex Trail Mix, Net Wt 28 oz (793g), Distributed by Wal Mart Stores, Inc., Bentonville, AR, packed in rigid clear plastic jars. Event 67208 | Ann's House of Nuts, Inc | Food | Class II | 1 |
| 19 Dec 2013 | ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment. | Spacelabs Healthcare, Llc | Device | Class II | 1 |
| 19 Dec 2013 | Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity. Event 67237 | Name withheld | Device | Class II | 1 |
| 19 Dec 2013 | Mexpogroup Cactus Grown in Mexico; 44 lbs, 20 KG; Calle El Rosario #20581 Col Buenos Aires Norte C.P. 22700 Tijuana, Mexico. Event 67187 | Shasta Produce | Food | Class II | 1 |
| 18 Dec 2013 | Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical… | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 18 Dec 2013 | ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems | Siemens Healthcare Diagnostics, Inc | Device | Class II | 2 |
| 18 Dec 2013 | ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control… | Horiba Instruments, Inc dba Horiba Medical | Device | Class III | 1 |
| 18 Dec 2013 | Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister). | Teva Pharmaceuticals USA | Drug | Class II | 2 |
| 17 Dec 2013 | Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 16 Dec 2013 | VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03. | Bracco Diagnostics Inc | Drug | Class III | 1 |
| 13 Dec 2013 | B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications. | B. Braun Medical, Inc. | Device | Class II | 1 |
| 13 Dec 2013 | SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position. | Highland Metals, Inc. | Device | Class II | 2 |
| 13 Dec 2013 | Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories Limited Bachepalli -500 090 INDIA NDC 55111-467-01 Event 67293 | Name withheld | Drug | Class II | 1 |
| 13 Dec 2013 | Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10 Event 67291 | Corepharma LLC | Drug | Class II | 1 |
| 13 Dec 2013 | Fresh Cactus ("Nopal"), 40lbs/bx Event 67280 | Marquez Produce Inc. | Food | Class II | 1 |
| 13 Dec 2013 | Hnos. Perez brand cactus leaves (pads): distributed by: West Coast Produce 300 Franklin St. Oakland, CA 94607 Event 67186 | West Coast Produce, LLC | Food | Class III | 1 |
| 12 Dec 2013 | Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. | GE Healthcare | Device | Class II | 6 |
| 12 Dec 2013 | GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems… | GE Healthcare, LLC | Device | Class II | 1 |
| 10 Dec 2013 | External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental | BioHorizons Implant Systems Inc | Device | Class II | 1 |
| 9 Dec 2013 | BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in… | Becton Dickinson & Co. | Device | Class II | 2 |
| 9 Dec 2013 | Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body 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… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 9 Dec 2013 | Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Synergetics Inc | Device | Class II | 28 |
| 9 Dec 2013 | Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose Delivery System containing 2 mL Sterile Water for Injection, USP per carton (NDC 52544-188-76), 11.25 mg, Rx Only, Dist. By: Watson Pharma, Inc., Morristown, NJ 07962, Mfd. by: Debio RP, CH-1920… | Actavis Inc | Drug | Class II | 1 |
| 6 Dec 2013 | ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA. | RTI Surgical, Inc. | Device | Class II | 1 |
| 6 Dec 2013 | Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 5 Dec 2013 | GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 5 Dec 2013 | Integra Cusa Excel Rx Only CEM" Nosecone for CUSA Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 5 Dec 2013 | Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc.,… Event 67171 | Symmetry Medical/SSI | Device | Class II | 1 |
| 5 Dec 2013 | Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 4 Dec 2013 | S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. | Sorin Group Deutschland GmbH | Device | Class II | 2 |
| 4 Dec 2013 | Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a… | Invivo Corporation | Device | Class II | 1 |
| 4 Dec 2013 | Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476) | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 27 Nov 2013 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station. | GE Healthcare, LLC | Device | Class II | 1 |
| 27 Nov 2013 | Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02. | Wockhardt Usa Inc. | Drug | Class II | 1 |
| 26 Nov 2013 | Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. | Beckman Coulter Inc. | Device | Class II | 2 |
| 26 Nov 2013 | Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument. | Orthofix, Inc. | Device | Class II | 1 |
| 26 Nov 2013 | Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Aqueous solution. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic. Sold under the following… | Humco Holding Group, Inc | Drug | Class II | 1 |
| 25 Nov 2013 | Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move… | Elekta, Inc. | Device | Class II | 1 |
| 25 Nov 2013 | Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. | Elekta, Inc. | Device | Class II | 1 |
| 25 Nov 2013 | XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. | Elekta, Inc. | Device | Class II | 1 |
| 25 Nov 2013 | Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Number 45-020; 4) 8F/SL/Plastic Port/F,… | Navilyst Medical, Inc. | Device | Class II | 1 |
| 22 Nov 2013 | D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole… | Bio-Rad Laboratories, Inc. | Device | Class III | 1 |
| 22 Nov 2013 | Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320 | Faria Limited LLC dba Sheffield Pharmaceuticals | Drug | Class II | 3 |
| 21 Nov 2013 | Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball. | Neuro Kinetics, Inc. | Device | Class II | 1 |
| 21 Nov 2013 | ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex. | Horiba Instruments, Inc dba Horiba Medical | Device | Class II | 1 |
| 20 Nov 2013 | Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 20 Nov 2013 | GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.… | GE Healthcare, LLC | Device | Class II | 1 |
| 20 Nov 2013 | Marina's German Bakery; Assorted Pastries; 2 pieces, Minimum Wt. 6 oz. 170 g; UPC# 010801003018; 2033 Trawood Dr., El Paso, Texas 79935 Event 66910 | Marina's German Bakery | Food | Class I | 1 |
| 20 Nov 2013 | Shortbread Almond Crescent cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz. | The Lambs Farm, Inc. | Food | Class II | 9 |
| 18 Nov 2013 | 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02 | Baxter Healthcare Corp. | Drug | Class I | 1 |
| 18 Nov 2013 | KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9. | Fougera Pharmaceuticals Inc. | Drug | Class III | 1 |
| 18 Nov 2013 | Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3. | SS Wholesale Inc. dba Jobbers Wholesale | Drug | Class I | 3 |
| 15 Nov 2013 | BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision… | Brainlab AG | Device | Class II | 1 |
| 15 Nov 2013 | GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic… | GE Healthcare, LLC | Device | Class II | 1 |
| 15 Nov 2013 | Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 15 Nov 2013 | BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880 | Actavis Inc | Drug | Class III | 1 |
| 14 Nov 2013 | California Girl canned Peach Halves in Juice, 6 cans per case. UPC 52391 72992 Event 66858 | Atlapac Trading Company Inc | Food | Class II | 1 |
| 13 Nov 2013 | Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33 | Forest Pharmaceuticals Inc | Drug | Class III | 3 |
| 12 Nov 2013 | Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation… Event 66835 | Medtronic Advanced Energy, LLC | Device | Class II | 1 |
| 8 Nov 2013 | ZYM B Reagent (REF 70493) 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 France Chemin De L'Or | Device | Class II | 3 |
| 8 Nov 2013 | Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 7 Nov 2013 | Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 7 Nov 2013 | Digestive enzyme capsules sold under the NOW Foods, Beeyoutiful, Best in Nature, Bluegrass Naturals Vitamin Company, Chicago Nutrition Company, Gluten-Free Remedies, Osa's Garden, and Professional Naturopathics brands and packaged in a plastic bottle containing 60 or 120 capsules. | NOW Foods | Food | Class II | 1 |
| 6 Nov 2013 | Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement,… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 4 Nov 2013 | Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6. Event 66771 | Alexion Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 4 Nov 2013 | Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66 | Pfizer Inc. | Drug | Class III | 1 |
| 4 Nov 2013 | Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com Event 66965 | IQ Formulations, LLC | Drug | Class I | 1 |
| 4 Nov 2013 | Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2 | Greenstone Llc | Drug | Class III | 1 |
| 30 Oct 2013 | The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are manufactured from titanium alloy. Surgical… Event 67117 | ACUTE Innovations, LLC | Device | Class II | 1 |
| 29 Oct 2013 | Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes. | Kimberly-Clark Corporation | Device | Class II | 1 |
| 25 Oct 2013 | Digestive, Enzyme Supplement, packaged 90 capsules per bottle, 135 capsules per bottle, or 270 capsules per bottle. They are sold under brand Enzyme Research Products or Empower Life. | Health Wright Products Inc | Food | Class II | 9 |
| 23 Oct 2013 | Lam Sheng Kee Fu Zhou Vermicell, Net Wt. 4.4 LB (2000 g), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6949682 803360; Manufactured by LAM SHENG KEE (HK) INTERNATIONAL LIMITED RM3. 8/F, YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI HK; Distributed by: S&M INT'L INC 100 Pulaski Street,… | Lsg Food World Inc | Food | Class III | 1 |
| 23 Oct 2013 | Bean Paste Bread, Net Wt. 420 g, product is packaged within a plastic bag with twelve (12) bags per carton. | Lsg Food World Inc | Food | Class III | 2 |
| 16 Oct 2013 | Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients. | Bausch & Lomb Surgical, Inc. | Device | Class II | 1 |
| 15 Oct 2013 | Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11 | B. Braun Medical Inc | Drug | Class I | 1 |
| 11 Oct 2013 | Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461. | Zimmer, Inc. | Device | Class II | 44 |
| 11 Oct 2013 | Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGREDIENTS***USE BY***ABBOTT LABORATORIES" | Abbott Nutrition | Food | Class II | 1 |
| 10 Oct 2013 | VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 9 Oct 2013 | GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. | GE Healthcare, LLC | Device | Class II | 1 |
| 8 Oct 2013 | enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides… | Ortho-Clinical Diagnostics | Device | Class II | 2 |
| 7 Oct 2013 | User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 2 Oct 2013 | MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. | Nipro Diagnostics, Inc. | Device | Class II | 2 |
| 2 Oct 2013 | Triarco Industries, LLC an Innophos company Multicolor Lightening Drink Granulation Notice - For Manufacturing Use Only Not for Resale | Triarco Industries, Inc. | Food | Class II | 4 |
| 30 Sep 2013 | Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.… | Merit Medical Systems, Inc. | Device | Class I | 1 |
| 17 Sep 2013 | Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy. | DeRoyal Industries Inc | Device | Class II | 6 |
| 11 Sep 2013 | The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy… Event 67248 | ArjoHuntleigh Inc. | Device | Class II | 1 |
| 11 Sep 2013 | ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon… | Exactech, Inc. | Device | Class II | 1 |
| 9 Sep 2013 | Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons. | PACK Pharmaceuticals, LLC | Drug | Class III | 6 |
| 27 Aug 2013 | T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK. For… | Siemens Healthcare Diagnostics | Device | Class II | 2 |
| 23 Aug 2013 | CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH Event 66313 | Central Shared Services dba Parallon | Drug | Class II | 1 |
| 20 Aug 2013 | Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator… | Carestream Health Inc. | Device | Class II | 1 |
| 23 Jul 2013 | Bolt: Fat Incenerator capsules packaged within a container (60 capsules per bottle). | Mira Health Products Ltd. | Food | Class II | 1 |
| 16 Jul 2013 | Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 12 Jul 2013 | 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover | Custom Medical Specialties, Inc. | Device | Class II | 1 |
| 2 Jul 2013 | MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702. | Ecolab Inc | Device | Class II | 6 |
| 16 May 2013 | Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright… Event 67076 | The Standing Company | Device | Class II | 1 |
| 16 May 2013 | Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of… | Codman & Shurtleff, Inc. | Device | Class II | 7 |
| 15 May 2013 | HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433. Event 65273 | Health & Beyond | Drug | Class II | 1 |
| 8 May 2013 | Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML Event 66139 | Fusion Pharmaceuticals, LLC | Drug | Class II | 1 |
| 24 Apr 2013 | Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393. | Insight Instruments, Inc. | Drug | Class II | 1 |
| 15 Apr 2013 | The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry. Event 64921 | Apothecure, Inc | Drug | Class II | 1 |
| 15 Apr 2013 | HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244 | NuVision Pharmacy, Inc. | Drug | Class I | 2 |
| 31 Mar 2013 | The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories. | Sysmex America, Inc. | Device | Class II | 1 |
| 22 Mar 2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles) | Actavis Inc | Drug | Class II | 1 |
| 20 Nov 2012 | The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data… | GE Healthcare It | Device | Class III | 1 |
| 12 Feb 2012 | The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared… Event 67249 | Ossur Americas, Inc. | Device | Class II | 1 |
| 31 Mar 2011 | AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs. | The Anspach Effort, Inc. | Device | Class II | 2 |
| 7 Mar 2011 | Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are 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… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 1 Jul 2005 | Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients. Event 67241 | Siemens Hearing Instruments, Inc | Device | Class II | 1 |