| 6 Feb 2015 | Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 30 Jan 2015 | Haitai Tayo Crackers, 140 g, 24 boxes/carton, in box colors: blue, yellow, and red. | HAMCHOROM INC | Food | Class I | 2 |
| 29 Jan 2015 | El Campestre Chicken Sasonador Ingredients: Water, Salt, Orange Juice Concentrate, Paprika, Guar Gum, Vinegar, Bijol, Garlic, Onion, Spices, Sugar, 0.1% Sodium Benzoate, and Potassium Sorbate NET WT. 1 GAL. (3.79L) After Opening Keep Refrigerated Ingredients: Water, Salt, Orange Juice Concentrate, Lemon Juice… | El Campestre, Inc. | Food | Class II | 3 |
| 28 Jan 2015 | Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 . | Akorn, Inc. | Drug | Class II | 1 |
| 28 Jan 2015 | Amana Dinner Rolls, packaged in 1 lb 2 oz plastic bags (70403) | The Jefferson Street Bakery Inc. | Food | Class I | 1 |
| 26 Jan 2015 | Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System. | Haemonetics Corporation | Device | Class II | 1 |
| 26 Jan 2015 | Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection. (70465) | AnazaoHealth Corporation | Drug | Class II | 1 |
| 23 Jan 2015 | PROBAR Frosted Peanut Butter BASE Protein Bar, 2.46 oz film wrapped bar packaged in 12 wrapped units per sleeve/carton. Unit UPC:8-53152-10060-5. 12 count box UPC: 8-53152-10061-2. (70360) | Probar LLC | Food | Class I | 1 |
| 22 Jan 2015 | GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages the Fixture Mount Transfer (FMT) to… | Zimmer Dental Inc | Device | Class II | 1 |
| 22 Jan 2015 | Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures. | Mako Surgical Corporation | Device | Class II | 1 |
| 22 Jan 2015 | FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management… | Carl Zeiss Meditec AG | Device | Class II | 1 |
| 22 Jan 2015 | Go Raw Organic Spice Seed Mix; Net Wt. 1 lb (454 g) USDA Organic UPC 8 59888 00040 Ingredients: Sprouted Organic Pumpkin Seeds, Sprouted Organic Sunflower seeds, Organic Jalapeno, Organic Cilantro, Organic Lime Juice, Organic Spices, Celtic Sea Salt, Organic Garlic Powder. Handmade by Freeland Foods Mountain View, CA… | Freeland Foods Inc. | Food | Class I | 2 |
| 21 Jan 2015 | Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and visualization functions, including basic… (70426) | TeraRecon, Inc. | Device | Class II | 1 |
| 21 Jan 2015 | Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC). Intended… | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 21 Jan 2015 | HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 21 Jan 2015 | Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86 | Sun Pharma Global Fze | Drug | Class II | 1 |
| 16 Jan 2015 | Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 16 Jan 2015 | BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP | CME America, LLC | Device | Class II | 1 |
| 16 Jan 2015 | Chopped Twix, chopped candy bars pieces packaged in 5 lb plastic white film bags, 2 bags per case (70314) | Tarrier Foods Corp | Food | Class I | 1 |
| 15 Jan 2015 | da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 15 Jan 2015 | Twix Bismark. This is not a packaged item. Twix Bismarcks are produced daily to be sold in bakery display cases at certain SA, BP, Circle K and Marathon Stores. | Northern Tier Bakery (dba\ Super Mom's) | Food | Class I | 1 |
| 15 Jan 2015 | Fruitful Juice Products Bloody Mary Beverage Concentrate with Jalapeno Flavor; Contains 59% Juice; 2 + 1 packed in 3 gal Bag in Box UPC 7 00073 02003 4 Manufactured by Damon Industries, Sparks, NV | Damon Industries | Food | Class II | 7 |
| 14 Jan 2015 | Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m) | Baxter Healthcare Corp. | Device | Class II | 1 |
| 14 Jan 2015 | Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier… | Teleflex Medical | Device | Class II | 15 |
| 13 Jan 2015 | Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 13 Jan 2015 | SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It… | CareFusion 303, Inc. | Device | Class II | 1 |
| 13 Jan 2015 | KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices. | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 13 Jan 2015 | LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situation and the… | Teleflex Medical | Device | Class II | 1 |
| 13 Jan 2015 | Condies Foods, Bold & Zesty Salsa, 14 oz, UPC: 05077744220 | Condies Foods, Inc | Food | Class II | 3 |
| 13 Jan 2015 | Mint Bar, refrigerated, single slice wrapped in cellophane, net wt. 8 oz. The product's label read in parts: "***my sweet ol' etcetera bakery***Mint Bar***Ingredients org flour, org. egg, butter (milk), chocolate, sugar, vanilla, peppermint oil, powdered sugar, butter (milk), cream, melted chocolate***8 oz.***250 oak… | Individual firm, name withheld | Food | Class II | 2 |
| 12 Jan 2015 | MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to… | Teleflex Medical | Device | Class I | 1 |
| 12 Jan 2015 | Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for… | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Device | Class II | 1 |
| 12 Jan 2015 | ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 12 Jan 2015 | ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 12 Jan 2015 | La Flor ground COMINO, 1) NET WT. 2 OZ, 2) NET WT 6 OZ (170.1g), 3) NET WT. 5 LBS. Packed By La Flor Products Co., Inc., Hauppauge, NY 11788 Tel 631-851-9601. http://www.laflor.com (70211) | La Flor Products Co., Inc. | Food | Class I | 1 |
| 12 Jan 2015 | Melatonin Control- Released Tablets, 60 tablets, in plastic bottles, Manufactured by Douglas Laboratories, Pittsburgh, PA. (70272) | HVL, LLC | Food | Class III | 1 |
| 10 Jan 2015 | 7-Eleven FRESH TO GO Fruit Mania 6 ounce UPC 0-52548-51982-7; No brand name sold at Circle K stores Fruit Mania 6 ounce UPC 7-17524-77638-9 | Del Monte Fresh Produce North America, Inc | Food | Class I | 6 |
| 9 Jan 2015 | Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc) | Biomet, Inc. | Device | Class II | 2 |
| 9 Jan 2015 | Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body. (70238) | Alltech Medical Systems America Inc | Device | Class I | 1 |
| 9 Jan 2015 | Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing | Arrow International Inc | Device | Class III | 1 |
| 9 Jan 2015 | Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical. | Teleflex Medical | Device | Class II | 1 |
| 9 Jan 2015 | Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and… (70363) | Individual firm, name withheld | Device | Class III | 1 |
| 9 Jan 2015 | MorningStar Farms Spicy Black Bean Burger: 9.50 oz (4 ct) - UPC 2898939207; 18.90 oz (8 ct): UPC 2898971750; 8.7 lb case (48 ct): UPC 2898949938; 9.75 lb case (4 sleeve): UPC 2898997765; 12.75 lb case (4 sleeve): UPC 2898931651 | Kellogg USA Inc | Food | Class II | 2 |
| 9 Jan 2015 | Chicken of the Sea brand Chunk Light Tuna, Case UPC is 4800001164 and the Label UPC is 0 4800001164 0. 100 cases (24 cans/case) | Tri-Union Seafoods, L.L.C dba Chicken of the Sea. | Food | Class II | 1 |
| 7 Jan 2015 | This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD… | GE Healthcare | Device | Class I | 1 |
| 7 Jan 2015 | Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient. | Cincinnati Sub-Zero Products Inc | Device | Class II | 1 |
| 7 Jan 2015 | System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 7 Jan 2015 | Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner. | Elekta, Inc. | Device | Class II | 1 |
| 5 Jan 2015 | ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement. | Arrow International Inc | Device | Class II | 1 |
| 5 Jan 2015 | High Road Craft Ice Cream & Sorbet, Limoncello Sorbet, packed in 4.9L (1.3 gallon) tubs, Manufactured by: High Road Craft Ice Cream & Sorbet, Inc., 2241 Perimeter Park dr. Atlanta, GA 30341 (for restaurant use only). (70193) | High Road Craft Ice Cream, Inc. | Food | Class I | 1 |
| 5 Jan 2015 | Walnut Pieces packaged in the following sizes and brand names: 1. EILLIEN'S 2OZ, UPC 034952-007022, BEST BY 7/31/15; 2. EILLIEN'S 4OZ, UPC 034952-129991, BEST BY 9/10/15; 3. EILLIEN'S 11OZ TRAY, UPC 034952-572759, BEST BY 6/9/15; 4. EILLIEN'S 14OZ, UPC 034952-129977, with the following Best By dates: 7/30/15,… | Eillien's Candies, Inc. | Food | Class I | 1 |
| 3 Jan 2015 | Whole Foods Market Small Cookie Platter 18oz. UPC Code: 24386800000 Lot Code: All Medium Cookie Platter 35oz. UPC Code: 24387300000 Lot Code: All Large Cookie Platter 55oz. UPC Code: 24766100000 Lot Code: All Whole Foods From Whole Foods Markets Contains: Wheat, Eggs, Milk, and Soy Cookie platters and packed within… | Whole Foods Market | Food | Class I | 1 |
| 2 Jan 2015 | Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 2 Jan 2015 | ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins. | Arrow International Inc | Device | Class II | 1 |
| 2 Jan 2015 | EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during… | Natus Medical Incorporated | Device | Class II | 2 |
| 1 Jan 2015 | Hummus; All-natural ZILKS FAMOUS ORIGINAL HUMMUS GLUTEN FREE & NON-GMO NET WT. 8 OZ | Zilks Foods | Food | Class II | 7 |
| 31 Dec 2014 | Thera Tablets with Beta Carotene Dietary Supplement | The Harvard Drug Group, LLC | Food | Class III | 1 |
| 31 Dec 2014 | Cheese sold unde the brand name, EWELICIOUS BLEATING HEART RAW SHEEPS MILK SALT CULTURES. Sold with a Whole Foods Market scale label in clear plastic wrap. Variable weight item. | Whole Foods Market | Food | Class I | 6 |
| 30 Dec 2014 | Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO | Clinical Innovations, LLC | Device | Class II | 1 |
| 30 Dec 2014 | Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8. | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class II | 1 |
| 30 Dec 2014 | Chopped walnuts packaged in 8 oz. (226 g) plastic bags under the Fisher brand. | John B. Sanfilippo & Son Inc. | Food | Class I | 2 |
| 30 Dec 2014 | Ground cumin seed; Received in 50 lb. bags Shipped in 25# bags Country of Origin - Turkey: Certified Kosher; Starwest Botanicals, Sacramento, CA Received from Schiff Food Products Co. ,Inc. Totowa, NJ 07512 | Starwest Botanicals, Inc | Food | Class I | 1 |
| 26 Dec 2014 | Cumin Seed, Ground, packed as NET WT 1 lb, Reorder: #HS300, and NET WT 5 lb, Reorder: #HS310. Regional Access Inc. 607-319-5150, Email: food@regionalaccess.net (70198) | Regional Access Inc | Food | Class I | 1 |
| 24 Dec 2014 | Mimi's Products Ground Cumin, (Comino Molido), 1 oz. (28g), UPC 707425-054242 and 9 oz. (266g), UPC 70742-5032318, Packed by NAC Foods Corp., 235 Commercial Avenue, Palisades Park, NJ 07650. | N.A.C. Foods | Food | Class I | 2 |
| 24 Dec 2014 | Ground Cumin Seeds, ETO Treated, 50 lbs packaged in 50 lb brown paper bags (70114) | Schiff Foods Products | Food | Class I | 1 |
| 24 Dec 2014 | Banana ice cream is packed in 2.5 gallon bulk, 1.5 gallon bulk, or half gallon retail size tubs. Retail size ice cream flavor is labeled in part, "***Husky Ice Cream, Inc. 4721 California Ave SW Seattle, WA 98116 HUSKY "Cream of the Town" HALF GALLON ICE CREAM www.huskydeli.com INGREDIENTS: CREAM, MILK, SKIM MILK… | Husky Ice Cream,Inc | Food | Class I | 44 |
| 24 Dec 2014 | Groove Gluten-Free Chocolate Chip Cookie & French Vanilla Ice Cream Sandwich. The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove. The UPC codes are 8 52692 00404 6 and 8 52692 00400 8. | Great Feeling Foods | Food | Class I | 6 |
| 24 Dec 2014 | Pink's Ice Cream - Black Sesame. 16 oz Paper Carton and 1 gallon plastic container | Individual firm, name withheld | Food | Class I | 8 |
| 23 Dec 2014 | Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients. | Cardinal Health | Device | Class II | 1 |
| 23 Dec 2014 | Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions. (70149) | Shape Medical Systems, Inc | Device | Class II | 1 |
| 23 Dec 2014 | Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446. | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 23 Dec 2014 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30 | Hospira Inc. | Drug | Class II | 1 |
| 23 Dec 2014 | Raw Milk Cheddar Cheese, packaged in 8-oz. blocks and 5-lb. loafs. (70108) | Farm Country Cheese House, Inc. | Food | Class I | 1 |
| 23 Dec 2014 | Pear Huckleberry Sorbet; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon). | Numbskull LLC | Food | Class I | 115 |
| 22 Dec 2014 | Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012). | Stryker Instruments Div. of Stryker Corporation | Device | Class III | 1 |
| 22 Dec 2014 | Salted Caramel ice cream, labeled in part, "***Full Tilt ice cream Salted Caramel***Ingredients: cream, milk, sugar, skim milk powder, vanilla, carob bean gum, guar gum, soy lecithin, carrageenan, salt***Seattle WA 98106 www.fulltilticecream.com***". Ice cream is packaged in 16 oz paper containers, and 1.5 gallon and… | Individual firm, name withheld | Food | Class I | 17 |
| 19 Dec 2014 | Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 19 Dec 2014 | LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300,… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 19 Dec 2014 | BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog… | Becton Dickinson & Company | Device | Class II | 1 |
| 19 Dec 2014 | The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical… | Integra LifeSciences Corporation | Device | Class II | 1 |
| 19 Dec 2014 | HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710 | Fresenius Kabi USA, LLC | Device | Class II | 1 |
| 19 Dec 2014 | Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. | Sunrise Medical (US) LLC | Device | Class II | 2 |
| 19 Dec 2014 | Soybean Sprouts, net wt. 1.5 lbs., sold under brand Winter Blossom Bean Sprouts brand. Product is packaged in plastic bag, multi-colored with orange stripe on top, lower middle portion and at bottom. The orange & black English and Korea letters on white background on front of bag. the UPC is 0 94922 55330 0. Soybean… | Individual firm, name withheld | Food | Class I | 2 |
| 19 Dec 2014 | Caramel Apples packaged in the following configurations with Best By date range - 8/25-11/23/2014, Responsible firm name on label is Happy Apple Inc., Washington, MO., and Orosi, CA.,: Happy Apples Simply Caramel Value 3 Pack, Net Wt. 9 oz., Happy Apples Simply Caramel 4 Pack, Net Wt. 14 oz., Happy Apples Simply… | Lochirco Fruit & Produce Inc | Food | Class I | 8 |
| 19 Dec 2014 | Dried Bean Curd Satay Flavor, 24x150g, Item No. 8533. | Gemini Food Corporation Inc | Food | Class II | 5 |
| 19 Dec 2014 | Raw, Shelled Hazelnuts, sold in self-serve bulk bins. | The Kroger Co | Food | Class I | 1 |
| 18 Dec 2014 | Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 18 Dec 2014 | CARROLL SHELBY'S ORIGINAL TEXAS BRAND CHILI KIT, NET WT. 4 oz. (113 g), Dist. by Reily Foods Company, New Orleans, LA 70130, 1-800-535-1961, UPC 0-00-72396-10000-8 | Reily Foods Co. | Food | Class I | 4 |
| 17 Dec 2014 | Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites,… | Smiths Medical ASD, Inc. | Device | Class III | 1 |
| 17 Dec 2014 | Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. | Aesculap, Inc. | Device | Class II | 1 |
| 17 Dec 2014 | MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR… | Individual firm, name withheld | Device | Class II | 4 |
| 17 Dec 2014 | Market Pantry Brand Dark Chocolate Covered Almonds 9 oz., UPC 085239555644 (70049) | Zachary Confections, Inc. | Food | Class I | 1 |
| 17 Dec 2014 | Bleating Heart Cheese, Ewelicious Blue, Sheep Milk Blue Cheese Handcrafted with whimsy in California; Ingredients: Raw sheep milk, salt, cultures, rennet. Aged 2 months or more. | Bleating Heart Cheese LLC | Food | Class I | 10 |
| 16 Dec 2014 | ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 16 Dec 2014 | CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic… | Maquet Datascope Corp - Cardiac Assist Division | Device | Class II | 1 |
| 15 Dec 2014 | Beckman Coulter, Lipase Assay, Catalog No. OSR6X30 | Beckman Coulter Inc. | Device | Class II | 4 |
| 15 Dec 2014 | 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates. | Synthes, Inc. | Device | Class II | 1 |
| 15 Dec 2014 | Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 12 Dec 2014 | R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. | Teleflex, Inc. | Device | Class II | 1 |
| 11 Dec 2014 | Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in assessing the thickness of the articular surface… | Zimmer, Inc. | Device | Class II | 1 |
| 10 Dec 2014 | 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1 | The Anspach Effort, Inc. | Device | Class II | 1 |
| 10 Dec 2014 | Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. | Covidien | Device | Class I | 2 |
| 8 Dec 2014 | Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 8 Dec 2014 | ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. | Radiometer America Inc | Device | Class II | 1 |
| 8 Dec 2014 | Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system. | Mobius Imaging, LLC | Device | Class II | 1 |
| 5 Dec 2014 | G- Series Beds; G29 full length bed rails assembly | Invacare Corporation | Device | Class II | 1 |
| 5 Dec 2014 | Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery. (69963) | Orthosensor, Inc. | Device | Class II | 1 |
| 5 Dec 2014 | Hot Smoking BBQ Sauce | Son In Law Products | Food | Class II | 5 |
| 4 Dec 2014 | MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases… | Teleflex, Inc. | Device | Class I | 1 |
| 3 Dec 2014 | VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014. | INNOKAS MEDICAL OY | Device | Class II | 1 |
| 26 Nov 2014 | SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0 (69837) | Individual firm, name withheld | Device | Class II | 1 |
| 26 Nov 2014 | VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Plugs are place in the upper and/or lower… (70036) | Lacrimedics Inc | Device | Class III | 1 |
| 25 Nov 2014 | Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic). | Zimmer, Inc. | Device | Class II | 1 |
| 24 Nov 2014 | Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component. | Arthrosurface, Inc. | Device | Class II | 5 |
| 21 Nov 2014 | DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result. (70008) | Express Diagnostics Int'l., Inc. | Device | Class II | 1 |
| 21 Nov 2014 | Jumbo, In-shell, Bulk Hazelnuts packed in 50-lb poly weave plastic sacks. No UPC. (70202) | Willamette Filbert Growers Inc | Food | Class I | 1 |
| 12 Nov 2014 | The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and… | GE Healthcare | Device | Class II | 1 |
| 12 Nov 2014 | BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 10 Nov 2014 | Arriba! 16 oz. Chili Con Queso-Hot; 6 units per case | Riba Foods Inc | Food | Class II | 6 |
| 4 Nov 2014 | Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. (69782) | Pulsion Medical Inc | Device | Class II | 1 |
| 27 Oct 2014 | LaBree's Bakery Chocolate Chip Mini Muffins, 12 pack. Net wt. 10 oz. packaged in plastic clamshell. Frozen Product Code: 7778 (69834) | LaBree's Bakery | Food | Class III | 1 |
| 21 Oct 2014 | HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 17 Oct 2014 | The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105 03.305.500 03.305.500S Intended to stabilize and provide… | Synthes, Inc. | Device | Class II | 1 |
| 16 Oct 2014 | 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045 | Hospira Inc. | Drug | Class I | 1 |
| 10 Oct 2014 | Bologna & Cheese, Net Wt. 3.00 oz., UPC 7-01248-00309-9, MFG Code 1038; Thick Bologna & Cheese, Net Wt. 4.50 oz., UPC 7-01248-00913-7, MFG Code 258 | SunBurst Foods, Inc. | Food | Class I | 121 |
| 6 Oct 2014 | Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01. | Hospira Inc. | Drug | Class I | 4 |
| 22 Sep 2014 | Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients. (69388) | Virtual Imaging, Inc. | Device | Class II | 1 |
| 9 Sep 2014 | Coconut Bun, NET WT. 4 OZ. Product is packaged in an uncoded, plastic bag with green font. MADE BY GOLDEN KING BAKERY, INC. 90 Bowery New York, NY 10013 212-680-0138. (69309) | Golden King Bakery | Food | Class I | 1 |
| 26 Aug 2014 | The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope. (70051) | MAST Biosurgery USA, Inc | Device | Class II | 1 |
| 6 Aug 2014 | MobileDiagnost wDR motorized portable diagnostic X-ray systems. (70237) | Individual firm, name withheld | Device | Class II | 1 |
| 10 Jul 2014 | LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09 | Hospira Inc. | Drug | Class I | 1 |
| 11 Jun 2014 | Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. The pole clamp assembly is used… | Hospira Inc. | Device | Class II | 1 |
| 20 May 2014 | SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory. (70021) | Individual firm, name withheld | Device | Class II | 1 |
| 18 Apr 2014 | 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02. | Hospira Inc. | Drug | Class I | 1 |
| 23 Oct 2012 | The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and… | Siemens Medical Solutions USA, Inc. | Device | Class II | 2 |
| 27 Mar 2012 | MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment. | Nidek Inc | Device | Class II | 1 |
| 22 Feb 2012 | Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used with the Timberline Lateral System to… | Biomet Spine, LLC | Device | Class II | 1 |
| 6 Jan 2012 | Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces. | Synthes, Inc. | Device | Class II | 1 |
| 19 Dec 2011 | Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Inserters. The Inserter… | Biomet Spine, LLC | Device | Class II | 1 |
| 6 Sep 2011 | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. | Animas Corporation | Device | Class II | 1 |