| 6 Nov 2013 | Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040 (66773) | Candela Corporation | Device | Class II | 1 |
| 6 Nov 2013 | Lifeforce Medical Institute Ultra Power; Optimal Vitamin/Mi neral. Trace Element/Anti-Oxidant Detox Support Dietary Supplement. 10 tablets/Packet and 30 packets/1000cc bottle. Distributed by: Mark Rosenbloom, MD LIFEFORCE Medical Institute 60 Revere Dr., Ste. 820 Northbrook, IL 60062 (847) 905-9505 www.lifeforcemed.com | ProThera, Inc. | Food | Class II | 2 |
| 5 Nov 2013 | Walnut shaped soft Cookie packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20644D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 3/20/14 With Korean language labeling | Cho & So, Inc. DBA Oh Bok Bakery | Food | Class II | 3 |
| 4 Nov 2013 | Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 3 Nov 2013 | Trader Giotto's CAESAR Salad with Caesar Dressing; Perishable, keep refrigerated. Packaged in Net Wt. 8.5 oz (241 g) plastic clamshell. Manufactured for Trader Joe's Manufactured by Ghiringhelli Specialty Foods, inc. Vallejo, CA 94950. (66718) | Ghiringhelli Specialty Foods Inc. | Food | Class I | 1 |
| 1 Nov 2013 | Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line. | SALTER LABS | Device | Class II | 1 |
| 1 Nov 2013 | Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 1 Nov 2013 | Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by SUPERVALU Inc., Eden Prairie, MN 55344, NDC 41163-590-16,… | L. Perrigo Co. | Drug | Class II | 4 |
| 1 Nov 2013 | Digestive Enzymes, 60 Capsules/Bottle under the following brand names: 21st Century Digestive Enzymes, 60 Capsules/Bottle. HyVee Digestive Eymes, 60 Capsules/Bottle. (66743) | 21st Century Healthcare, Inc. | Food | Class II | 1 |
| 31 Oct 2013 | Trader Joe's Southwest Salads, 9oz. Packaged in plastic clamshell with ranch dressing packaged in plastic sealed solo cup. Product labeling reads in part:"TRADER JOE'S ***SOUTHWEST SALAD with Black Beans, Corn, Cotija Cheese and a tangy Ranch Dressing***NET WT. 9 OZ (255g)***DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S… | World Class Distribution, Inc. | Food | Class I | 1 |
| 30 Oct 2013 | Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position. | Ergosafe Products LLC DBA Prism Medical Services USA | Device | Class II | 2 |
| 30 Oct 2013 | Best in Nature Brand Eye Care Essence, 100 Capsules. Product labeling reads in part:"Best in Nature Eye Care Essence***Dietary Supplement 100 capsules***Manufactured for: Best in Nature Walnut, CA 91789***www.1688best.com***8 92418 001069 6***". (66679) | Diamond Nutriceutical, Inc. | Food | Class II | 1 |
| 28 Oct 2013 | TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery,… | Trumpf Medical Systems, Inc. | Device | Class II | 1 |
| 28 Oct 2013 | Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 28 Oct 2013 | Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N… | Synovis Surgical Innovations, Inc. | Device | Class II | 2 |
| 25 Oct 2013 | GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma,… | GE Healthcare, LLC | Device | Class II | 1 |
| 25 Oct 2013 | Fruit Truffles - Cherry, Coconut, Key Lime, Lemon, Mango, Pear, Pineapple and Tangelo flavors. (6 piece count/4.5 oz) Pear, Lemon, Key Lime, Coconut flavors contain FD&C Y5 and/or Y6; (9 piece count/7 oz) Pear, Cherry, Tangelo, Coconut, Lemon, Key Lime flavors contain FD&C Y5 and/or Y6 ; (12 piece count/9 oz) Mango,… (66634) | Torn Ranch Inc. | Food | Class II | 1 |
| 24 Oct 2013 | Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other… (66609) | Ossur North America Inc | Device | Class II | 1 |
| 24 Oct 2013 | Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In… | Nobel Biocare Usa Llc | Device | Class II | 1 |
| 24 Oct 2013 | Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO 64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC… | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 24 Oct 2013 | Dual Action Cleanse by Cellular Research Formulas, 60 ct, Item AN027370, UPC 7 10363 27370 5, Item AN056592HFS, UPC 7 10363 56592 3; Item DR056439, UPC 7 10363 57369 0. | Irwin Naturals | Food | Class II | 3 |
| 24 Oct 2013 | Bairn Biologics Candisol; Natural Enzymes to Support a Health Gastrointestinal Tract. Dietary Supplement; Ingredients: Vegetarian Cellulase, Vegetarian Hemicellulase, Vegetarian Xylanase, Vegetarian Beta-glucanase, microcrystalline Cellulose, L-Leucine, Vegetable Capsule. Packaged in 40 and 120 count amber glass… (66738) | Bairn Biologics | Food | Class II | 1 |
| 24 Oct 2013 | CTF Brand Tapioca Pearl Pandan (Green Color), 14oz Plastic Bags, Packaged at 50 bags per case. Packaged in plastic heat-sealed pouch. Brand name is CTF with an illustration of a deer. Product labeling reads in part:"C.T.F. Brand TAPIOCA PEARL***EXPORTED: COMBINE THAI FOODS CO., LTD.***PRODUCT OF THAILAND NET… (66629) | N A Trading Inc | Food | Class II | 1 |
| 23 Oct 2013 | Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 23 Oct 2013 | Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and… | Carl Zeiss Meditec, Inc. | Device | Class II | 2 |
| 23 Oct 2013 | Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 23 Oct 2013 | Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan, Renfrewshire PA4 9RR… | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 23 Oct 2013 | ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut)… | ConMed Corporation | Device | Class II | 2 |
| 23 Oct 2013 | Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. | Terumo Cardiovascular Systems Corporation | Device | Class II | 4 |
| 23 Oct 2013 | EDGE, Item number 21-620, dietary supplement, 60 packet per box. The Edge product includes two different packets of capsules - a "Before" packet and an "After" packet. The suggested use for the After packet is one packet (or 6 capsules) per day. The suggested use for the "Before" packet is one packet (or 4 capsules)… | New Algae Company | Food | Class I | 2 |
| 21 Oct 2013 | VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital… | Vital Images, Inc. | Device | Class II | 1 |
| 21 Oct 2013 | da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD Vision System provides a high resolution image for… | Intuitive Surgical, Inc. | Device | Class III | 1 |
| 21 Oct 2013 | Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic tissue for the… (66598) | Urologix, Inc. | Device | Class II | 1 |
| 21 Oct 2013 | Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue,… | Applied Medical Resources Corp | Device | Class II | 1 |
| 21 Oct 2013 | Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or… | Individual firm, name withheld | Device | Class I | 8 |
| 21 Oct 2013 | GlutenFlam (K-52) Enzyme & Bioflavonoid Dietary Supplement, 60 vegetarian capsules | Individual firm, name withheld | Food | Class II | 4 |
| 21 Oct 2013 | All-Natural Greens Dietary Supplement; Manufactured Exclusively for NatureRich, Maple Grove, MN 55369. | Empirical Laboratories, Incorporated | Food | Class II | 13 |
| 18 Oct 2013 | Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products | Device | Class II | 1 |
| 18 Oct 2013 | Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed diagnostic EP catheters are indicated for… | Stryker Sustainability Solutions | Device | Class II | 1 |
| 18 Oct 2013 | Organic Chevre sold at Farmer's Market in plastic 6 oz tubs, vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand. Product also sold to in 2 lbs. and 3 lbs. to restaurant. Product is labeled in parts: "***Organic Goat Dairy***Chevre***SUNNY PINE FARM***6 oz***Pasteurized Organic Goat Milk, Salt,… | Individual firm, name withheld | Food | Class II | 4 |
| 17 Oct 2013 | CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline… | Del Mar Reynolds Medical, Ltd. | Device | Class I | 1 |
| 17 Oct 2013 | Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth | GlaxoSmithKline, LLC. | Device | Class II | 1 |
| 17 Oct 2013 | Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices… | Spacelabs Healthcare, Llc | Device | Class II | 1 |
| 17 Oct 2013 | Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms. | Spacelabs Healthcare, Llc | Device | Class II | 1 |
| 17 Oct 2013 | EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis. | Philips Medical Systems North America Inc. | Device | Class II | 1 |
| 17 Oct 2013 | KCB Pista Khatie KCB Bakery Products Corp. 56-28 56th Street, Maspeth, NY 11378 Tel: (718) 786-9463 Fax (718) 361-0171 www.kbcusa.com a) Net Wt. 30 OZ (850 G) b) Net Wt. 13 OZ (369 G) Packaged in a plastic clam shell container with stick-on labels. (66579) | Kashmir Crown Baking LLC | Food | Class I | 1 |
| 15 Oct 2013 | Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube. | Teleflex Medical | Device | Class II | 1 |
| 14 Oct 2013 | Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 14 Oct 2013 | Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare… | Philips Healthcare Informatics, Inc. | Device | Class II | 1 |
| 13 Oct 2013 | Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. | Individual firm, name withheld | Device | Class II | 4 |
| 11 Oct 2013 | US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation… | St. Jude Medical | Device | Class II | 1 |
| 11 Oct 2013 | GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved… | GE Healthcare, LLC | Device | Class II | 1 |
| 11 Oct 2013 | Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 11 Oct 2013 | Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter. | St. Jude Medical | Device | Class II | 1 |
| 11 Oct 2013 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. | Hospira Inc. | Drug | Class II | 1 |
| 11 Oct 2013 | Custom made gift boxes containing: HONEY ROASTED PEANUTS, Net Wt. 11 oz. (311G), Dist.By: Dutch Valley Food Distributors, Inc. Myerstown, PA 10787, UPC 8 77245 00143 3 (66512) | yoders country market | Food | Class I | 1 |
| 11 Oct 2013 | Spectrazyme, 180 count, 60 count, 12 bottles/case, 20000 tablets/box, 14000 capsules/pail. (66511) | Metagenics, Inc. | Food | Class II | 1 |
| 10 Oct 2013 | Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip. | Biomet, Inc. | Device | Class II | 1 |
| 10 Oct 2013 | the Snack Artist BBQ Flavored Potato Chips, Net Wt. 10 oz. (283 g), UPC 21130-29106. Distributed by Safeway, Inc. Pleasanton, CA 94566 (66484) | Barrel O' Fun Snack Foods Co. | Food | Class I | 1 |
| 10 Oct 2013 | Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 28054 00149 7; Manufactured by: ProThera, Inc., Reno, NV 89521 | ProThera, Inc. | Food | Class II | 5 |
| 9 Oct 2013 | Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction… | Zimmer, Inc. | Device | Class II | 1 |
| 9 Oct 2013 | Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92 | Sandoz, Inc | Drug | Class II | 1 |
| 8 Oct 2013 | White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE HOMINY; NET WT 36.8 oz. (2 lb. 4.8 oz.) 1043g | Quaker Foods and Snacks North America | Food | Class II | 2 |
| 8 Oct 2013 | Good Sense Spicy Sweet Mix, 25-oz (1lb 9oz) plastic container, UPC: 030243787178 (66466) | Krispak Inc | Food | Class II | 1 |
| 7 Oct 2013 | GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic | Smith & Nephew Inc | Device | Class II | 2 |
| 7 Oct 2013 | Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients. | Medtronic Vascular, Inc. | Device | Class II | 1 |
| 7 Oct 2013 | Pringles(R) SALT & VINEGAR Potato Chips, 168 g (UPC 064100852464) and 181 g (UPC 037000230090), Pringles Manufacturing Company, 1306 Highway 70 Bypass, Jackson, TN, USA 38301-5072 (66476) | Kellogg Canada Corporate Office | Food | Class II | 1 |
| 7 Oct 2013 | Beachbody Optimize Enzymes Capusles, 126 CT, 8 oz. Container size: JAR 8OZ WHITE 70MM NECK POLYPROPYLENE 126 capsules per bottle. Product labeling reads in part:" BEACHBODY ULTIMATE OPTIMIZE Promotes healthy metabolism and effective body funtions***DIETARY SUPPLEMENT 126 Capsules***BEACHBODY, LLC Santa Monica, CA***". | Cgnp Manufacturing | Food | Class II | 2 |
| 6 Oct 2013 | Red and Green Bell Peppers, 25 lbs. (66453) | Orange County Produce | Food | Class I | 1 |
| 4 Oct 2013 | VIT-RA-TOX Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged in 150 tablets glass, amber bottles. No. 48. National Distributors: V.E. Irons, Inc, N. Kansas City, MO. Springreen Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged in 150 tablets glass, amber bottles. No. 88.… (66446) | Vitalab Co Inc | Food | Class II | 1 |
| 4 Oct 2013 | 10 inch Apple Pie (baked and unbaked), NET WT 42 oz.(2 lb 10 oz), UPC 41735-22064 (unbaked) and 41735-23712 (baked), Price Chopper label. (66471) | Price Chopper Supermarkets | Food | Class II | 1 |
| 4 Oct 2013 | Digestive Health, 90 vegetable capsules (66510) | Ultra Laboratories | Food | Class II | 1 |
| 3 Oct 2013 | Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach,… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 3 Oct 2013 | Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 3 Oct 2013 | Cellulase: ACTA 4-702 APEX 17-6262 APEX 6-9762 ARTH EB 10831 BETA GLUCANASE 1000 BROOK 8-352 CELLULASE 1000 CELLULASE 4000 CELLULASE CONC. CENTURY 7-152 CLENZSEB DIGESEB DIGESEB PB DIGESEB PLUS DIGESEB PLUS 401 DIGESEB SUPER DIGESEB SUPER 118 EB 10-14081 EB 10-15351 EB 12-706 EB 14-14201 EB 16-15612 EB 17-14161 EB… | Individual firm, name withheld | Food | Class II | 5 |
| 2 Oct 2013 | The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended… | EKOS Corporation | Device | Class II | 1 |
| 2 Oct 2013 | REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 2 Oct 2013 | Single Site Bipolar Maryland Forceps Intuitive Surgical, 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 an operating room environment for endoscopic manipulation of tissue,… | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 2 Oct 2013 | WELLTRIENTS DIGESTAIDS FORMULA #2, 90 capsules per bottle. Item #61256-90 (66508) | Creation's Garden Natural Products Inc | Food | Class II | 1 |
| 1 Oct 2013 | Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 (66423) | Helix Medical LLC | Device | Class III | 1 |
| 1 Oct 2013 | Western Nut Salt Lake City Roasted and Salted Inshell Peanuts, 6 oz (170g). Packaged in OPP (oriented polypropylene) bags. Receive bulk roasted/salted inshell peanuts from US Foods in 25 lb lined cases. Manufactured by Hampton Farms, Portales, NM for Western Nut. (66520) | Western Nut Company, Inc. | Food | Class II | 1 |
| 1 Oct 2013 | Apotheca Energique Gastrozyme, dietary supplement, 100 vegetarian capsules. (66443) | Grato Inc. | Food | Class II | 1 |
| 30 Sep 2013 | Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or… | Individual firm, name withheld | Device | Class II | 2 |
| 30 Sep 2013 | Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbid obesity | Ethicon Endo-Surgery Inc | Device | Class II | 3 |
| 30 Sep 2013 | Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. | Individual firm, name withheld | Device | Class II | 2 |
| 30 Sep 2013 | Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care | Draeger Medical, Inc. | Device | Class II | 1 |
| 30 Sep 2013 | Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A | American Laboratories Inc | Food | Class II | 9 |
| 27 Sep 2013 | Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or… (66410) | Individual firm, name withheld | Device | Class II | 1 |
| 27 Sep 2013 | OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline… | Insulet Corporation | Device | Class II | 2 |
| 27 Sep 2013 | Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for thromboembolitic disease, -… | Cordis Corporation | Device | Class II | 1 |
| 27 Sep 2013 | Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Vanilla UPC 36632 02721 | The Dannon Company, Inc. | Food | Class II | 6 |
| 26 Sep 2013 | HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its… | Hamilton Medical, Inc. | Device | Class II | 1 |
| 26 Sep 2013 | 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good… | OrthoPediatrics Corp | Device | Class II | 1 |
| 26 Sep 2013 | Swanson, Premium Brand, Full Spectrum Black Cumin Seed (Nigella Sativa) Dietary Supplement capsules, 400 mg, SW1361, UPS 0 87614 11361 6. | Swanson Health Products, Inc | Food | Class III | 1 |
| 26 Sep 2013 | Cellulase Enzyme Blends, bulk, custom blended formulations identified as Cellulase BX and Celluase Conc, packed in boxes or drums ranging from 1 kg to 25 kg, item # CELIND, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail:… | Bio-Cat Inc | Food | Class II | 3 |
| 25 Sep 2013 | Giant Eagle Candy Place Candy Corn Mix in a clear plastic container, net wt. 13 oz, Distributed by Giant Eagle Inc. UPC#3003406974 | Giant Eagle, Inc. | Food | Class I | 1 |
| 25 Sep 2013 | Angel Food Cake; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cake 0 lb. 12 oz. (340 g) Black or White Base with Clear Lid | Safeway Inc | Food | Class I | 5 |
| 24 Sep 2013 | S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less. | Sorin Group Deutschland GmbH | Device | Class II | 1 |
| 24 Sep 2013 | COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of… | Beckman Coulter Inc. | Device | Class II | 1 |
| 24 Sep 2013 | UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop… | Beckman Coulter Inc. | Device | Class II | 1 |
| 24 Sep 2013 | SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient… | Baxter Healthcare Corp. | Device | Class II | 1 |
| 24 Sep 2013 | Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 24 Sep 2013 | Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on… | Siemens Healthcare Diagnostics | Device | Class II | 1 |
| 24 Sep 2013 | Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 USA +1-201-760-8000 XIA 3 Spinal… (66657) | Individual firm, name withheld | Device | Class II | 1 |
| 24 Sep 2013 | Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-3414-01 | Hospira Inc. | Drug | Class II | 2 |
| 23 Sep 2013 | Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and… | Baylis Medical Corp * | Device | Class I | 1 |
| 23 Sep 2013 | Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional… | Smiths Medical ASD, Inc. | Device | Class II | 9 |
| 23 Sep 2013 | ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations | Ivoclar Vivadent, Inc. | Device | Class II | 1 |
| 23 Sep 2013 | Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9702-01. | West-Ward Pharmaceutical Corp. | Drug | Class II | 2 |
| 23 Sep 2013 | Jim Dandy¿ Iron Fortified Quick Grits, 1lb paper box, Labeled in part "INGREDIENTS: IRON, WHITE CORN GRITS, NIACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 11501 5***3067 511 Best If Used By 8-NOV-14***" | J M Smucker Co | Food | Class II | 12 |
| 20 Sep 2013 | Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US) | Aesculap, Inc. | Device | Class II | 1 |
| 20 Sep 2013 | Serene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dietary supplement, 45 Tablets, Item #: SN0237; 90 Tablets, Item #: SN0240; 180 Tablets, Item #: SN0268; Product label states, "manufactured for Source Naturals, Inc., P.O. Box 2118, Santa Cruz, CA 95062"; and distributed by Threshold… | Threshold Enterprises Ltd | Food | Class II | 1 |
| 19 Sep 2013 | Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes:… (66433) | Atossa Genetics, Inc. | Device | Class I | 1 |
| 19 Sep 2013 | AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When… | GE Healthcare, LLC | Device | Class II | 1 |
| 18 Sep 2013 | Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile;… | Richard Wolf Medical Instruments Corp. | Device | Class II | 1 |
| 18 Sep 2013 | P.F. Chang's Home Menu, Pork & Leek Dumplings, frozen, packaged in 12.5 oz bags. UPC: 0 36200 21215 8 | Conagra Inc | Food | Class I | 1 |
| 17 Sep 2013 | Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5. | Amgen, Inc. | Drug | Class II | 1 |
| 16 Sep 2013 | Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0¿ 6… | Edwards Lifesciences, LLC | Device | Class I | 1 |
| 16 Sep 2013 | COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 16 Sep 2013 | PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation. | Pentax Medical Company | Device | Class I | 1 |
| 16 Sep 2013 | Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all… | Carestream Health Inc. | Device | Class II | 50 |
| 16 Sep 2013 | Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43 (66218) | Kremers Urban Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 13 Sep 2013 | pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). Used in the hemodialysis setting to calibrate pH meters. | Mesa Laboratories, Inc. | Device | Class II | 1 |
| 13 Sep 2013 | Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. | Mylan Pharmaceuticals Inc. | Drug | Class II | 12 |
| 13 Sep 2013 | Idahoan, Steakhouse Parmesan topping, Net Weight 35 lbs., Item Code ZID800Bulk. | Kerry Foods | Food | Class II | 1 |
| 12 Sep 2013 | MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system. | Maquet Medical Systems USA | Device | Class II | 1 |
| 12 Sep 2013 | Access 2 Immunoassay System, Part Number: 81600N 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 | 1 |
| 12 Sep 2013 | Schwebel's Golden Rich Bun with Honey, 18 oz plastic bag, 12 count, UPC 0 71319 00083 8 Product labeled in part, "INGREDIENTS: ENRICHED WHEAT FLOUR***CONTAINS: WHEAT, SOY SCHWEBEL BAKING CO. YOUNGSTOWN, OH 44501" (66265) | Schwebel Baking Company | Food | Class I | 1 |
| 12 Sep 2013 | St. Marcellin Au lait pasteurise fabrique en Dauphine l'unite: poids net 80ge Fromagerie Qurtet 38470 VINAY (66463) | Epicure Food Corp. | Food | Class I | 1 |
| 10 Sep 2013 | Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 10 Sep 2013 | Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These… | Integra Limited | Device | Class II | 1 |
| 10 Sep 2013 | Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental… (66391) | Wexford Labs Inc | Device | Class II | 1 |
| 9 Sep 2013 | ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples. | Beckman Coulter Inc. | Device | Class II | 2 |
| 9 Sep 2013 | Multi Complete (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case.+++Multi Complete (club size) (Full Strength Mini and Multi Softgels), 180 Count Bottle. 20 units per master case. Product labeling reads in part:"NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made… | Pharmavite Corporation | Food | Class II | 4 |
| 8 Sep 2013 | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-149-04. | Hill Dermaceuticals, Inc. | Drug | Class III | 2 |
| 6 Sep 2013 | Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma… (66362) | Small Bone Innovations, Inc. | Device | Class II | 1 |
| 6 Sep 2013 | chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens. | bioMerieux, Inc. | Device | Class II | 1 |
| 5 Sep 2013 | Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110. (66200) | Fallon Wellness Pharmacy Llc | Drug | Class II | 1 |
| 4 Sep 2013 | Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total… (66331) | SEPPIM SAS | Device | Class II | 1 |
| 4 Sep 2013 | Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated… | Baxter Healthcare Corp. | Device | Class II | 1 |
| 4 Sep 2013 | Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31 | Pfizer Us Pharmaceutical Group | Drug | Class II | 1 |
| 4 Sep 2013 | Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2. | Greenstone Llc | Drug | Class II | 2 |
| 3 Sep 2013 | BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 3 Sep 2013 | ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring. | Siemens Healthcare Diagnostics | Device | Class II | 4 |
| 1 Sep 2013 | Creafuse Grape, 600 Grams | GE PHARMA LLC - | Food | Class II | 2 |
| 31 Aug 2013 | Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function | Invacare Corporation | Device | Class II | 1 |
| 30 Aug 2013 | Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 30 Aug 2013 | Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip. | Zimmer, Inc. | Device | Class II | 13 |
| 30 Aug 2013 | Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 30 Aug 2013 | GoPicnic Black Bean Dip & Plantain Chips; ready-to-eat meal kit with professor zim zam's extraordinary sweets dark chocolate with orange packaged in paperboard container; NET WT 4.2 OZ (116.2g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com; | GoPicnic, Inc. | Food | Class I | 2 |
| 29 Aug 2013 | DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients | Carestream Health Inc. | Device | Class II | 2 |
| 29 Aug 2013 | Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 29 Aug 2013 | 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 3 |
| 29 Aug 2013 | DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components… | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 2 |
| 28 Aug 2013 | Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft | Globus Medical, Inc. | Device | Class II | 1 |
| 28 Aug 2013 | Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx¿ II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for… | Zimmer, Inc. | Device | Class II | 1 |
| 28 Aug 2013 | VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty. | Zimmer, Inc. | Device | Class II | 1 |
| 28 Aug 2013 | S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor… | SpineFrontier, Inc. | Device | Class II | 1 |
| 28 Aug 2013 | *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be identified by the "E10" that is printed beneath… | Hospira Inc. | Device | Class II | 1 |
| 26 Aug 2013 | Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours)… | Edwards Lifesciences, LLC | Device | Class II | 2 |
| 26 Aug 2013 | Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or… | Bayer Healthcare Llc | Device | Class II | 1 |
| 26 Aug 2013 | Amport Foods Chocolate Raisins. Net Wt. 12 oz (340g). UPC 71725-71190. Allergy Information: This product is produced on equipment shared with peanuts and tree nut products. | American Importing Co, Inc | Food | Class II | 1 |
| 22 Aug 2013 | Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully… (66353) | Individual firm, name withheld | Device | Class II | 1 |
| 22 Aug 2013 | BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system | Ebi, Llc | Device | Class II | 1 |
| 17 Aug 2013 | Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 | Amneal Pharmaceuticals of New York, LLC. | Drug | Class II | 1 |
| 16 Aug 2013 | Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 16 Aug 2013 | ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems. | Siemens Healthcare Diagnostics, Inc | Device | Class III | 1 |
| 15 Aug 2013 | Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as… | Steris Corporation | Device | Class II | 1 |
| 13 Aug 2013 | Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 12 Aug 2013 | DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye | DeRoyal Industries Inc | Device | Class II | 1 |
| 12 Aug 2013 | Mixed nuts in a plastic bag labeled in part: PREMIUM QUALITY; Terri Lynn Inc.; Deluxe Mixed; No Peanuts; NET WT. 16 OZ. (1 LB.) 454 g; P.O. BOX 5118 ELGIN, IL 60121 | Terri Lynn Inc. | Food | Class I | 2 |
| 5 Aug 2013 | Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging | Toshiba American Medical Systems Inc | Device | Class II | 4 |
| 31 Jul 2013 | Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. (66144) | Fujinon Inc | Device | Class II | 1 |
| 31 Jul 2013 | PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. | DePuy Spine, Inc. | Device | Class II | 5 |
| 30 Jul 2013 | US Pistachio Shelled, Halves, Raw, Net Weight: 30lbs. (65864) | Primex Intl Trading Corp | Food | Class I | 1 |
| 26 Jul 2013 | DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas. | Carestream Health, Inc. | Device | Class II | 1 |
| 25 Jul 2013 | HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden | HemoCue AB | Device | Class II | 1 |
| 24 Jul 2013 | ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process. (66587) | Trumpf Medical Systems | Device | Class III | 1 |
| 23 Jul 2013 | Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors. | Elekta, Inc. | Device | Class II | 1 |
| 16 Jul 2013 | HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in… | HemoCue AB | Device | Class II | 1 |
| 28 Jun 2013 | PRIESTER'S PECANS brand brand ROASTED SALTED PISTACHIOS, item #18010, Net Wt. 1 lb (454g), UPC 720056180104; item #15502, Net Wt. 8 oz (226.8g), UPC 001001155027; Stock No. 189, Net Wt. 2 lb (907g) | Priester Pecan Company, Inc. | Food | Class I | 3 |
| 27 Jun 2013 | MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired. | Insight Instruments, Inc. | Device | Class II | 1 |
| 19 Jun 2013 | DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas | Carestream Health Inc. | Device | Class II | 1 |
| 12 Jun 2013 | VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. | Ortho-Clinical Diagnostics | Device | Class II | 37 |
| 11 Jun 2013 | The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare… | GE Healthcare It | Device | Class II | 1 |
| 10 Jun 2013 | SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 6 Jun 2013 | Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images. | Carestream Health, Inc. | Device | Class II | 1 |
| 23 May 2013 | Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles. | Pinook-Usa | Device | Class II | 2 |
| 20 May 2013 | Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures. | Olympus America Inc. | Device | Class II | 1 |
| 15 May 2013 | pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter… | Sysmex America Inc | Device | Class II | 1 |
| 6 May 2013 | Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 10 Apr 2013 | Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera Ranch, CA (64878) | Affirm XL, Inc. | Drug | Class I | 1 |
| 3 Apr 2013 | Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59 | Boehringer Ingelheim Roxane Inc | Drug | Class II | 1 |
| 15 Mar 2013 | The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered… | Hospira Inc. | Device | Class I | 2 |
| 12 Mar 2013 | 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 II | 1 |
| 11 Mar 2013 | Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and… | GE Healthcare It | Device | Class II | 1 |
| 1 Feb 2013 | The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad… | Hospira Inc. | Device | Class II | 8 |
| 21 Jan 2013 | Artis zee systems x-ray, angiographic system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 13 Dec 2012 | Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in… | Riverpoint Medical, LLC | Device | Class II | 1 |
| 29 Nov 2012 | Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) Handset component devices operate the Minivator Bath Bliss Reclining Bath Lift, a non-AC-powered patient lift… (63859) | Individual firm, name withheld | Device | Class II | 1 |
| 19 Sep 2012 | Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System. | Medtronic Vascular, Inc. | Device | Class II | 1 |
| 17 Sep 2012 | Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the… | Siemens Healthcare Diagnostics Inc | Device | Class II | 7 |
| 15 Jun 2012 | Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy… | Ge Healthcare It | Device | Class II | 1 |
| 15 May 2012 | Big Burst Orange Drink in a 16 oz PET bottle with a sports cap, American Beverage Corp., Verona, PA. | American Beverage Corp | Food | Class II | 27 |
| 5 Feb 2012 | Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care | Hospira Inc. | Device | Class II | 7 |
| 17 Oct 2011 | da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 8 Aug 2011 | Siemens syngo.plaza image processing system image processing radiological system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 6 May 2011 | Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone. | The Anspach Effort, Inc. | Device | Class II | 3 |
| 27 Jul 2010 | Xoran Mini CT Scanner | Xoran Technologies, Inc. | Device | Class II | 1 |
| 27 Jul 2010 | Xoran MiniCAT00202 | Xoran Technologies, Inc. | Device | Class II | 1 |
| 27 Jul 2010 | Xoran Minicat00202 | Xoran Technologies, Inc. | Device | Class II | 2 |
| 27 Jul 2010 | Xoran MiniCAT CT Scanner | Xoran Technologies, Inc. | Device | Class II | 1 |
| 14 Dec 2009 | Xoran MiniCAT CT Scanner ID ENT00001 | Xoran Technologies, Inc. | Device | Class II | 1 |
| 11 Dec 1930 | Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument… | Intuitive Surgical, Inc. | Device | Class II | 1 |