| 12 Dec 2013 | King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents. | King Systems Corp. | Device | Class II | 1 |
| 2 Oct 2013 | Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only, Rx Only, 25 x 3 mL Sterile Unit-Dose Vials per carton, Manufactured By: Nephron Pharmaceuticals Corporation, Orlando, FL 32811, NDC 0487-9501-25 | Nephron Pharmaceuticals Corp. | Drug | Class II | 1 |
| 30 Sep 2013 | Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in… | Bard Peripheral Vascular Inc | Device | Class I | 1 |
| 25 Sep 2013 | Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01. | Sandoz Incorporated | Drug | Class III | 1 |
| 23 Sep 2013 | Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality… | Alere San Diego, Inc. | Device | Class III | 1 |
| 23 Sep 2013 | Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Watson Laboratories Inc, 132 Business Center Drive, Corona, CA 92880. | Watson Laboratories Inc | Drug | Class II | 1 |
| 23 Sep 2013 | Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04. | Tolmar, Inc. | Drug | Class III | 1 |
| 23 Sep 2013 | Fancy Mixed Nuts (25lbs), Mixed Nuts (25lbs), and Super King Fancy Mixed Nuts (25lbs) (66369) | American Nut Company | Food | Class II | 1 |
| 20 Sep 2013 | Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct… | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 20 Sep 2013 | Frozen Sliced Carrots, packaged in 2 lbs. bag, sold under Simplot Classic brand. The UPC is 0 71179 1846 3 1. The product is labeled in parts: "***SIMPLOT CLASSIC***Sliced Carrots***NET WT 32 OZ. (2 LBS)***INGREDIENTS: CARROTS***KEEP FROZEN UNTIL READY TO USE. IF THAWED. DO NOT REFREEZE***Preparation… (66375) | Norpac Foods, Inc. | Food | Class I | 1 |
| 19 Sep 2013 | IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS). | AGFA Corp. | Device | Class II | 1 |
| 19 Sep 2013 | Wegmans Bakery Mini Muffins APPLE CINNAMON, NET WT 14 OZ (397g) , UPC 77890 18951 --- Baked By Wegmans Food Markets Inc., Rochester, NY 14603 | Wegmans Food Markets | Food | Class I | 1 |
| 18 Sep 2013 | GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The… (66341) | GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD | Device | Class II | 1 |
| 18 Sep 2013 | STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products | Device | Class II | 1 |
| 18 Sep 2013 | STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products | Device | Class II | 1 |
| 18 Sep 2013 | Sensations Asian Supreme Salad Kit; 220 g/7.8 oz. Product os USA/Produit des E. U. A. Taylor Farms, Salinas, CA 93901 | Taylor Farms Retail, Inc. | Food | Class II | 1 |
| 18 Sep 2013 | Dannon ACTIVIA¿ LIGHT Nonfat Yogurt Strawberry-Banana & Peach Flavor, 12 PACK of 4oz cups, Form fill seal 4oz cup | The Dannon Company, Inc | Food | Class II | 1 |
| 17 Sep 2013 | Fruit Rush Black Cherry Artificially Flavored Fruit Drink, One Gallon, Plant 06-704 | Dean Foods, Inc. | Food | Class III | 3 |
| 16 Sep 2013 | SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 16 Sep 2013 | GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation. | GE Healthcare, LLC | Device | Class I | 1 |
| 16 Sep 2013 | STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy… | Abbott Medical Optics, Inc. | Device | Class II | 4 |
| 16 Sep 2013 | Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line… | Sekisui Diagnostics LLC | Device | Class II | 1 |
| 16 Sep 2013 | NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The… | Medtronic Vascular, Inc. | Device | Class II | 1 |
| 16 Sep 2013 | Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA. | Osmotica Pharmaceutical Corp | Drug | Class III | 1 |
| 13 Sep 2013 | Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 13 Sep 2013 | Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01 | Watson Laboratories Inc | Drug | Class II | 1 |
| 13 Sep 2013 | Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22 | Individual firm, name withheld | Drug | Class II | 2 |
| 13 Sep 2013 | Green Leaf Lettuce is sold in bulk cases under "Garre Farms" or "Rossi Farms" brand. There are 24 heads of green leaf lettuce packed in each cardboard box. The Garre Farms brand is labeled in parts: "***OREGON'S OWN!***Fresh Produce***GARRE FARMS, LLC***PORTLAND, OR 97230***PRODUCE OF U.S.A***". The Rossi Farms brand… (66279) | Garre Farms | Food | Class I | 1 |
| 12 Sep 2013 | Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology. (66361) | Convergent Dental | Device | Class II | 1 |
| 12 Sep 2013 | Honey Roasted Peanuts, net wt. 11 oz.., packed in a clear plastic bag. Ingredients: peanuts, sugar, peanut and/or canola and/or cottonseed oil, honey, salt, modified potato starch, xanthan gum. Allergen info: peanut and soy ingredients. Also states that facility also processes products containing, milk and wheat… | Dutch Valley Food Development Inc. | Food | Class II | 2 |
| 11 Sep 2013 | Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic… (66268) | Harvest Technologies Corporation | Device | Class II | 1 |
| 11 Sep 2013 | P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode,… (66346) | SonoSite, Inc. | Device | Class II | 1 |
| 10 Sep 2013 | Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional… | Smiths Medical ASD, Inc. | Device | Class II | 2 |
| 10 Sep 2013 | Meijer 8 Inch Carrot Uniced Split Cake Layers (product is packed in bulk cartons of 24 units/paper bags lined with flexible blue plastic liner). (66271) | Maplehurst Bakeries, Inc. | Food | Class II | 1 |
| 10 Sep 2013 | Talenti German Chocolate Cake Gelato, One Pint (473 mL), Crafted By: Talenti, Marietta, GA 30062. (66252) | Individual firm, name withheld | Food | Class II | 1 |
| 10 Sep 2013 | First Street Blueberry Muffins (S 45395), 14 oz., 9 trays/case, UPC 0 4151210833 4 | KDK Management, Inc., dba Bubbles Baking Co. | Food | Class I | 2 |
| 9 Sep 2013 | BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria… | Becton Dickinson & Co. | Device | Class II | 1 |
| 7 Sep 2013 | Almond Biscotti, 1 oz. and 0.5 oz. wrapped in plastic, with "Enjoy By dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA. Product size and UPC codes 0.5 oz., case of 100 units 758843915936, 1.0 oz., box of 4 units 758843915738 , 1.0 oz., box of 12 units 758843915950, 1.0 oz., case of 50 units… | Semifreddi's Inc. | Food | Class II | 2 |
| 6 Sep 2013 | ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms:… | Horiba Instruments, Inc dba Horiba Medical | Device | Class III | 1 |
| 6 Sep 2013 | Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same… | Hologic, Inc. | Device | Class II | 1 |
| 6 Sep 2013 | Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518. | Individual firm, name withheld | Drug | Class II | 2 |
| 6 Sep 2013 | Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA. (66272) | Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. | Drug | Class II | 1 |
| 6 Sep 2013 | Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135. | Individual firm, name withheld | Drug | Class II | 2 |
| 6 Sep 2013 | Tullys¿ House Blend Coffee 12-ct K-Cup¿ packs; Product Code: 8802 (Case of 6 - 12 count retail boxes) UPC: 10099555088028 | Green Mountain Coffee Roasters | Food | Class III | 2 |
| 5 Sep 2013 | Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of… (66310) | Perkin Elmer Health Sciences, Inc. | Device | Class II | 1 |
| 5 Sep 2013 | Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined… | Carefusion 211 Inc dba Carefusion | Device | Class I | 1 |
| 5 Sep 2013 | 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045 | Hospira Inc. | Drug | Class II | 1 |
| 5 Sep 2013 | 12/6 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01001-4; 6/16 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01007-6; 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Plain, UPC 8-94700-01013-7; 6/32 oz. Chobani 0% Non-Fat Greek Yogurt Plain-Club Pack, UPC 8-94700-10184-2 | Individual firm, name withheld | Food | Class II | 64 |
| 4 Sep 2013 | McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical… | Mckesson Information Solutions LLC | Device | Class II | 1 |
| 4 Sep 2013 | GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716 | Hi-Tech Pharmacal Co., Inc. | Drug | Class III | 1 |
| 4 Sep 2013 | JAMES FARM brand CUT GREEN BEANS (EJOTES CORTADOS), FRESH FROZEN, NET WT. 32 OZ. (2 LBS.) 907 g, UPC 7 60695 01004 2, PRODUCT OF POLAND -- Distributed by RD/JET, LLC 15-24 132nd Street, College Point, NY 11356 --- Product is harvested, sorted, graded, washed, cut/processed and blanched before snap freezing and… (66255) | Restaurant Depot | Food | Class II | 1 |
| 30 Aug 2013 | CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It… | CareFusion 303, Inc. | Device | Class II | 1 |
| 30 Aug 2013 | SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets… | CareFusion 303, Inc. | Device | Class II | 1 |
| 30 Aug 2013 | GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray… | GE Healthcare, LLC | Device | Class II | 1 |
| 30 Aug 2013 | Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 30 Aug 2013 | Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any… (66211) | Individual firm, name withheld | Device | Class II | 1 |
| 30 Aug 2013 | SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. | CareFusion 303, Inc. | Device | Class II | 1 |
| 30 Aug 2013 | spartan fresh selections american potato salad, Net Wt. 16 oz (1 LB) 454g. UPC 11213-90320. | Garden-Fresh Foods, Inc. | Food | Class I | 1 |
| 30 Aug 2013 | DANNON OIKOS Fruit on the Bottom GREEK NONFAT YOGURT BLUEBERRY 0% FAT | The Dannon Company, Inc. | Food | Class II | 1 |
| 29 Aug 2013 | Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices. | Steris Corporation | Device | Class II | 1 |
| 29 Aug 2013 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who… | Boston Scientific CRM Corp | Device | Class II | 2 |
| 29 Aug 2013 | 5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01 | Hospira Inc. | Drug | Class II | 1 |
| 29 Aug 2013 | Blythedale Farm Vermont Brie, 7 oz. wrapped disc in plastic cup UPC Code: 762713669010 | Blythedale Farm Inc. | Food | Class II | 3 |
| 28 Aug 2013 | GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation. | GE Healthcare, LLC | Device | Class I | 1 |
| 27 Aug 2013 | H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment. (66128) | H & H Associates | Device | Class I | 1 |
| 27 Aug 2013 | Pecan Brittle's label is read in parts: "***PECAN BRITTLE***INGREDIENTS: Sugar, corn syrup, pecans, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***". | Snoqualmie Falls Candy Factory, LLC | Food | Class II | 4 |
| 26 Aug 2013 | Irene's Black & White Cookies, 8 oz. (226.4g) All Natural. Ingredients: Sugar, wheat flour, water, eggs, canola oil, unmodified food starch, corn syrup, vegetable fat, cocoa powder processed with alkali, mono and diglycerides, sea salt, sodium acid pyrophosphate, sodium bicarbonate, mono calcium phosphate, soy… (66319) | Irene's Bakery & Gourmet Kitchen, Inc. | Food | Class I | 1 |
| 23 Aug 2013 | Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss. | Medtronic Xomed, Inc. | Device | Class II | 1 |
| 23 Aug 2013 | BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space. | Becton Dickinson & Company | Device | Class II | 1 |
| 23 Aug 2013 | Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX. (66330) | Walgreens Co | Drug | Class II | 1 |
| 23 Aug 2013 | Fresh Herbs Everyday Basil, Shenandoah Growers brand, packaged in .75 oz; 2 oz.; and 2.5 oz. in 3 count and 6 count cardboard sleeves and labeled in part ***Shenandoah Growers Inc., Harrisonburg, Va 22802*** | Shenandoah Growers, Inc. | Food | Class III | 2 |
| 21 Aug 2013 | SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns. | ASO, LLC | Device | Class II | 1 |
| 20 Aug 2013 | FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System. | Bio-Rad Laboratories | Device | Class III | 1 |
| 20 Aug 2013 | Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk. Mother's Milk Bank 751 S. Bascom Abe.San Jose, CA 95128 (66187) | Mothers Milk Bank | Food | Class II | 1 |
| 20 Aug 2013 | Hartley's Potato Chips Salt & Vinegar 4.5 oz and 2.5 oz bags Hartley's Potato Chip Co., Inc, Lewistown, PA Ingredients: potatoes, vegetable shortening, salt, lactose, sodium diacetate, salt, malic acid, sodium citrate, with not more than 2% silicon dioxide and partially hydrogenated soybean and/or cottonseed oil. (66053) | Hartleys Potato Chip Company Inc | Food | Class I | 1 |
| 19 Aug 2013 | The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE… | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 19 Aug 2013 | TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.com Manufacturer: Tyco Electronics Brand Name: Elo Touch… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 16 Aug 2013 | GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies. | GE Healthcare, LLC | Device | Class II | 1 |
| 15 Aug 2013 | QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 14 Aug 2013 | Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures. | Draeger Medical, Inc. | Device | Class I | 1 |
| 13 Aug 2013 | GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images,… | GE Healthcare, LLC | Device | Class II | 1 |
| 13 Aug 2013 | MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the… | Codman & Shurtleff, Inc. | Device | Class I | 8 |
| 12 Aug 2013 | Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine. | Abbott Laboratories, Inc | Device | Class II | 1 |
| 12 Aug 2013 | ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts. | Siemens Healthcare Diagnostics | Device | Class II | 1 |
| 12 Aug 2013 | Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system. | Cordis Corporation | Device | Class II | 1 |
| 9 Aug 2013 | VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 9 Aug 2013 | Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma. | OPTI Medical Systems, Inc | Device | Class II | 1 |
| 8 Aug 2013 | Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8. (65967) | Marlex Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 7 Aug 2013 | Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 1 Aug 2013 | Breaded, frozen shrimp packaged in plastic bags labeled in part: BREADED SHRIMP; NET WEIGHT; 2.0 LBS or 3 LBS (66102) | Gourmet Express Marketing, Inc. | Food | Class II | 1 |
| 31 Jul 2013 | Coconut Tree Brand; Mut Gung Non; Ginger Candy; Ing: Ginger, Sugar, Water Sold in 8 oz sealed plastic pouches, and 12 oz sealed shrink wrapped plastic tubs. P. By: E.T.I. San Jose, CA | Evershing International Trading Inc. | Food | Class II | 1 |
| 30 Jul 2013 | Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes. (66000) | Individual firm, name withheld | Device | Class II | 1 |
| 30 Jul 2013 | Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery. | Synergetics Inc | Device | Class II | 1 |
| 26 Jul 2013 | Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in… | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 23 Jul 2013 | DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of… (65883) | Microgenics Corp | Device | Class II | 1 |
| 22 Jul 2013 | MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 16 Jul 2013 | UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures. | Aesculap, Inc. | Device | Class II | 1 |
| 15 Jul 2013 | ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery. | Endoplus, Inc. | Device | Class II | 2 |
| 12 Jul 2013 | Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. | Atrium Medical Corporation | Device | Class II | 14 |
| 10 Jul 2013 | Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 2 Jul 2013 | Monaco RTP System Radiation treatment planning | Elekta, Inc. | Device | Class II | 1 |
| 2 Jul 2013 | Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10 (65889) | Core Pharma Llc | Drug | Class II | 1 |
| 28 Jun 2013 | Vinco's OsteoSheath Enhanced Bone Support, Calcium Supplement, 90 Tablets, distributed by Vinco, Inc., Evans City, PA; | Vinco Inc. | Food | Class II | 3 |
| 11 Jun 2013 | Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. Used in direct monitoring of the… | Integra LifeSciences Corp. | Device | Class II | 10 |
| 10 Jun 2013 | Dietary Supplements under the same formulation, Labeled and Packaged in the Following: MAX Brand Proste-Support, 150 Count Tablets. Product labeling reads in part:"Manufactured for: HealthMax Products Inc. Altadena, CA 91001***". | Healthmaxx Global Inc. | Food | Class I | 28 |
| 5 Jun 2013 | NatureMost LABORATORIES NATURAL WHEY POWER W / YERBA MATE VANILLA / ALMOND Dietary Supplement NET WEIGHT 3 LBS. (1362g). Product Number: 9950 | NatureMost of New England, Inc. | Food | Class I | 2 |
| 4 Jun 2013 | Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position. | Invacare Corporation | Device | Class II | 1 |
| 22 May 2013 | Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning. | Elekta, Inc. | Device | Class II | 1 |
| 7 May 2013 | Benefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sugar Free, packaged in 5.7-oz. (35 servings) bottles, UPC 300670068356, 9.4-oz (58 servings) bottles, UPC 300670068585, and 18.7-oz. (115 servings) bottles, UPC 300670068158. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ… | Novartis Consumer Health | Food | Class II | 6 |
| 9 Apr 2013 | GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w… | GE Healthcare, LLC | Device | Class II | 1 |
| 9 Apr 2013 | Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device. | Ebi, Llc | Device | Class II | 1 |
| 26 Mar 2013 | GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. | GE Healthcare, LLC | Device | Class II | 2 |
| 8 Mar 2013 | Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 8 Mar 2013 | Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 7 Mar 2013 | DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from… | DeVilbiss Healthcare LLC | Device | Class II | 1 |
| 11 Jan 2013 | Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 4 Jan 2013 | The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11,… (64454) | PhotoMedex, Inc. | Device | Class II | 1 |
| 19 Dec 2012 | Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 8 Oct 2012 | Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood. | Radiometer America Inc | Device | Class II | 1 |
| 2 Oct 2012 | Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information… | GE Healthcare It | Device | Class II | 1 |
| 23 Aug 2012 | Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece. | King Systems Corp. | Device | Class I | 1 |