| 12 Jun 2014 | Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 74002 5 | Thorne Research Inc | Drug | Class II | 2 |
| 4 Jun 2014 | Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide invasive or non-invasive ventilator support… | Nellcor Puritan Bennett Inc. (dba Covidien LP) | Device | Class II | 1 |
| 2 Jun 2014 | RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use (68535) | Ability Dynamics LLC | Device | Class II | 1 |
| 29 May 2014 | Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries. | Kerr Corporation | Device | Class II | 1 |
| 29 May 2014 | Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. | Mckesson Medical Immaging | Device | Class II | 1 |
| 29 May 2014 | iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment. | Elekta, Inc. | Device | Class II | 1 |
| 28 May 2014 | Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-1401-01 | Novartis Pharmaceuticals Corp. | Drug | Class III | 1 |
| 23 May 2014 | GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status. | GE Healthcare, LLC | Device | Class II | 1 |
| 23 May 2014 | MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. | Elekta, Inc. | Device | Class II | 1 |
| 23 May 2014 | Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01 (68513) | Individual firm, name withheld | Drug | Class II | 1 |
| 23 May 2014 | Fayette Creamery Jalapeno Pepper Raw Milk Cheddar Cold Pack Cheese, Net Wt. 8 oz (226g), UPC 09513-00008 (68377) | Brunkow Cheese of Wisconsin, Inc. | Food | Class II | 1 |
| 22 May 2014 | IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352 | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 22 May 2014 | Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 32 |
| 22 May 2014 | Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20. | Sandoz, Inc | Drug | Class II | 1 |
| 22 May 2014 | Whole Foods Thai Soba Noodle Salad , 9 oz. refrigerated plastic container UPC Code: 36406304107 | Whole Foods Market Group Inc. | Food | Class I | 1 |
| 21 May 2014 | RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts. | Teleflex Medical | Device | Class II | 1 |
| 21 May 2014 | Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. | Roche Diagnostics Operations, Inc. | Device | Class II | 3 |
| 20 May 2014 | Bulk shelled walnuts packaged in 25 lb. cardboard boxes labeled with GSF LLC, Combo Halves and Pieces, Visalia, CA. 4024 CHP, also labeled California Walnut Board 40242096 | Sherman Produce Co | Food | Class I | 2 |
| 20 May 2014 | KrustaVita¿ Bread of Life brand Sourdough Dark Rye Bread; Net Weight 20 oz (1.25 lb); packed in a clear plastic bag. UPC: 8 5243000200 6. (68359) | Royal Rye LLC | Food | Class II | 1 |
| 19 May 2014 | La Terra Fina All Natural Spinach & Kale Dip and Spread; Made with Greek Yogurt; Net Wt. 10 oz. (.625 lb) 284 g UPC 6 40410 51350 1; La Terra Fina, Union City, CA. | La Terra Fina Inc. | Food | Class III | 1 |
| 19 May 2014 | Market Basket, Dairy-Free, Gluten-Free Pancakes. Each package contains 12 pancakes in a 14.4 oz. (408 g) box with UPC 4970571120 | Middle East Bakery, Inc. | Food | Class I | 1 |
| 19 May 2014 | Rockman (Brand) Raw Peanuts with Red Skin, 12 oz. Packaged in plastic pouch. 12oz/60bags/carton. Labeled as "PEANUT" on packaging. Product labeling reads in part: "ROCKMAN***PEANUT N.W.: 12 OZ (342G)***DISTRIBUTED BY: ROCKMAN (AUSTRALIA) PTY LTD.***AUSTRALIA***PRODUCT OF CHINA***DISTRIBUTED BY: ROCKMAN COMPANY (USA)… | Rockman Company Usa Inc | Food | Class II | 2 |
| 16 May 2014 | Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy. | Teleflex Medical | Device | Class II | 1 |
| 16 May 2014 | Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15. | Actavis Inc | Drug | Class II | 1 |
| 16 May 2014 | Marzipan - Pink, Orange and Green; Packed in 1 lb, (16 oz.) plastic containers and and 10.5 lb. 4.76 kg) pails. Ingredient: Sugar, almonds, potassium sorbate, oil of bitter almonds. Mandelin: California Almonds and Almond Pastes, Wasco California 93280 (68319) | Mandelin Inc | Food | Class II | 1 |
| 15 May 2014 | Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System. | Ebi, Llc | Device | Class II | 1 |
| 15 May 2014 | IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. | Boston Scientific Corporation | Device | Class II | 6 |
| 15 May 2014 | Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional… | Philips Medical Systems, Inc. | Device | Class II | 2 |
| 15 May 2014 | Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or… | Bacterin International, Inc. | Device | Class II | 1 |
| 14 May 2014 | Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems. | Beckman Coulter Inc. | Device | Class II | 1 |
| 14 May 2014 | liveGfree Gluten Free Blueberry Pancakes NET WT 14.4 OZ, 12 pancakes Keep Frozen Distributed By Aldi, Inc., Batavia, IL 60510 (68290) | American Waffle | Food | Class I | 1 |
| 14 May 2014 | Poco Pac Salad Dressing, Distributed by Diamond Crystal Brands, Inc., Savannah, GA 31405, and packaged in single serve packets of 9 or 12 grams (g) of product. Product is packed as follows: 500 ct-9g (Product Code: 86251), 200ct-9g (Product Code: 86242) and 200 ct-12g (Product Code: 86228). | Diamond Crystal Brands, Inc. | Food | Class I | 1 |
| 14 May 2014 | Gavina Northwest Blend Dark Whole Bean Bag Net Wt. 5lb, Product label reads in part "***085895***DECAF EUROPEAN BLEND 5LBS WHOLEBEAN BAG***" (68301) | F. Gavina & Sons Inc. | Food | Class III | 1 |
| 13 May 2014 | Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005 | CooperSurgical, Inc. | Device | Class II | 1 |
| 13 May 2014 | Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. | Hologic, Inc. | Device | Class II | 2 |
| 13 May 2014 | The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical software for cranial, spine, ENT,… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 2 |
| 13 May 2014 | Dragonfly Brand Crushed Chili Powder, Net Wt. 6.3 oz plastic tubs. Product of Thailand UPC 7 21557-53317 8 Packed for: U.S. Trading Co., 21118 Cabot Blvd., Hayward, CA 94545 (68291) | Us Tov, Inc. Dba U.s. Trading Company | Food | Class I | 1 |
| 12 May 2014 | Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane. | Summit Medical, Inc. | Device | Class II | 1 |
| 12 May 2014 | VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System… | Ortho-Clinical Diagnostics | Device | Class II | 2 |
| 12 May 2014 | Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 12 May 2014 | Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234 | John W Hollis Inc | Drug | Class II | 19 |
| 9 May 2014 | Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 9 May 2014 | LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest. | Physio-Control, Inc. | Device | Class II | 1 |
| 9 May 2014 | Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 9 May 2014 | Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 8 May 2014 | MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator. | ConMed Corporation | Device | Class II | 1 |
| 8 May 2014 | Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment. | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 7 May 2014 | G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458. | Biomet, Inc. | Device | Class II | 2 |
| 7 May 2014 | Raclette du Haut Livradois Ste Fromagere du Livradois 63980 Fournols 13lbs or cut and wrapped (weight may vary) wrap in a wax paper in a case or wrapped in plastic wrap if cut; refrigerated | Individual firm, name withheld | Food | Class I | 2 |
| 6 May 2014 | Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed… | Beaver-Visitec International Inc. | Device | Class II | 1 |
| 5 May 2014 | Chernosliv cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 15.8 oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code | Asian Bakery | Food | Class II | 4 |
| 2 May 2014 | Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. . The Alere… | Alere San Diego, Inc. | Device | Class II | 1 |
| 2 May 2014 | Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers:… | GE Healthcare, LLC | Device | Class II | 1 |
| 2 May 2014 | Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda… (68295) | Individual firm, name withheld | Device | Class II | 1 |
| 2 May 2014 | Product label: Amport Foods, Granola, Cinnamon Crunch, 22 oz (1 lb, 6 0z), UPC 0 71725 72511 0, Best BY 03-26-15, Ingredients: wheat flakes, oat flakes , brown sugar, sugar, coconut oil, coconut, wheat flour, cinnamon, honey, natural vanilla, sea salt. Allergy Information: This product is produced on packaging… | American Importing Co, Inc | Food | Class II | 1 |
| 2 May 2014 | Caravelle CHILI POWDER HOT Net Weight 8 oz. (227G), plastic tub, UPC 080736115551. 24 units/case (68192) | Anhing Corporation | Food | Class I | 1 |
| 1 May 2014 | NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. | Fresenius Medical Care Holdings, Inc. | Device | Class III | 1 |
| 1 May 2014 | Hawaiian Coconut Pudding, Haupia Luau Dessert; Packaged in Net Wt. 2 oz. (57 g); Net wt. 4 oz. (114 g) and Net wt. 48 oz. (3 lb) 1.36 kg. Ingredients: Sugar, coconut "powder, corn starch, locust bean gum, carrageenan, maltodextrin. 2 oz UPC 073562000504; 4 oz UPC 073562000559; 3 lb UPC 073562000511, NOH Foods of… (68178) | E & M Corporation, Dba Noh Foods International Of Hawaii | Food | Class I | 1 |
| 1 May 2014 | Lily Bloom's Kitchen Chocolate Coconut Poparoons (68238) | Lily Bloom's Kitchen | Food | Class I | 1 |
| 1 May 2014 | CAPTAIN KRATOM GOLD XL 30 Grams MAENG DA CAPSULES CAPTAIN KRATOM GOLD 15 GRAMS MAENG DA CAPSULES CAPTAIN KRATOM PREMIUM THAI POWDER 15 Grams CAPTAIN KRATOM PREMIUM BALI CAPSULES 15 Grams CAPTAIN VIETNAM KRATOM PREMIUM PLATINUM STRAIN 15 GRAMS CAPTAIN KRATOM PREMIUM THAI LEAF 15 Grams CAPTAIN KRATOM 30 grams Thai… | Prep Enterprises Llc | Food | Class II | 2 |
| 30 Apr 2014 | IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography. | AGFA Corp. | Device | Class II | 1 |
| 30 Apr 2014 | PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument. | Microport Orthopedics INC. | Device | Class II | 1 |
| 30 Apr 2014 | American Spoon¿ Sour Cherry PRESERVES Richer in Fruit (56 Brix) Made in Small Batches Net Wt. 9.5 oz/269g, glass jar INGREDIENTS: Red Tart Cherries, , Sugar, Lemon Juice, Pectin. ALLERGY INFORMATION: Manufactured in a facility that also processes soybeans, milk, eggs, fish, and tree nuts. Refrigerate after opening… (68232) | American Spoon Foods, Inc. | Food | Class II | 1 |
| 29 Apr 2014 | Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician. | Convatec Inc. | Device | Class I | 1 |
| 29 Apr 2014 | Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor. (68226) | Childrens Medical Ventures | Device | Class II | 1 |
| 29 Apr 2014 | Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or… | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 29 Apr 2014 | Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the… | Synthes, Inc. | Device | Class II | 1 |
| 29 Apr 2014 | Organic Cocoa Cassava bars, 1.59 oz (45 g), individually packaged in foil pouches and sold under the Dr. Mercola brand. Sold at retail locations in display cases containing 12 bars per display case. 12 display cases are packaged in each master case. (68167) | Mercola Group | Food | Class II | 1 |
| 28 Apr 2014 | TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46 | Ferring Pharmaceuticals Inc | Drug | Class II | 1 |
| 25 Apr 2014 | RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 25 Apr 2014 | VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results. | Siemens Medical Solutions Diagnostics | Device | Class III | 1 |
| 25 Apr 2014 | BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries). | CryoLife, Inc. | Device | Class II | 1 |
| 25 Apr 2014 | PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544 | Prestige Brands Holdings | Drug | Class III | 2 |
| 25 Apr 2014 | Raw, frozen, vacuum-packaged rock fish (portions, fillets, and whole fish, various sizes). | T.H. Seafood Inc. | Food | Class II | 4 |
| 25 Apr 2014 | REDVINES FRUIT VINES Bites Cherry ARTIFICIALLY FLAVORED NET WT, 2 oz (57G) Nutrition Facts: ***Sodium 35g***ALLERGEN INFORMATION: CONTAINS WHEAT***AMERICAN LICORICE COMPANY, UNION CITY, CA 94587 UPC 0 41364 82001 9 | American Licorice Company | Food | Class III | 2 |
| 24 Apr 2014 | HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. Product… | Cenorin, LLC | Device | Class II | 1 |
| 24 Apr 2014 | MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 24 Apr 2014 | Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. | Davol, Inc., Subs. C. R. Bard, Inc. | Device | Class II | 15 |
| 23 Apr 2014 | ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 23 Apr 2014 | Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek¿ pouch. It is an undyed, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 metric),… (68153) | C P Medical Inc. | Device | Class II | 1 |
| 23 Apr 2014 | Synergy XVI Intended for radiation therapy treatment. | Elekta, Inc. | Device | Class II | 1 |
| 23 Apr 2014 | ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 23 Apr 2014 | Pacific Cod, skinless boneless fillet; vacuum packaged in a clear plastic bag. The wt of the fish is the only labeling included on this product. | Kodiak Wild Alaska Seafood | Food | Class II | 2 |
| 22 Apr 2014 | Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery. | Synthes, Inc. | Device | Class II | 1 |
| 22 Apr 2014 | United Bakery Grissini Parmesan Bread Sticks,; Made with Extra Virgin Olive Oil and Grano Padano Cheese; All Natural, Trans Fat Free; Packaged in 8 oz (227g) and 4.5 oz (128g) containers. Also packaged for Safeway - Safeway Select Parmesan Grissini Breadsticks, 8 oz. (227g) containers. Made in USA Ingredient: Wheat… (68119) | UB Inc DBA United Bakery & Co | Food | Class I | 1 |
| 22 Apr 2014 | Miravalle (brand) Achiote Molido Ground Annato (spice), 0.75oz. (68120) | Miravalle Foods, Inc | Food | Class I | 1 |
| 21 Apr 2014 | Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System 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 |
| 21 Apr 2014 | Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10. | Hospira Inc. | Drug | Class I | 1 |
| 17 Apr 2014 | enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 17 Apr 2014 | APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male… (68229) | Gen-Probe Inc | Device | Class III | 1 |
| 17 Apr 2014 | CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6. | Cubist Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 16 Apr 2014 | Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient. | Maquet Medical Systems USA | Device | Class II | 1 |
| 16 Apr 2014 | Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc. (68081) | Sakura Finetek USA Inc | Device | Class II | 1 |
| 16 Apr 2014 | Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor. | Integra LifeSciences Corp. | Device | Class II | 1 |
| 15 Apr 2014 | EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. | Biomet, Inc. | Device | Class II | 3 |
| 15 Apr 2014 | ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery. | Brainlab AG | Device | Class II | 1 |
| 14 Apr 2014 | bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing. | Ivoclar Vivadent, Inc. | Device | Class II | 1 |
| 14 Apr 2014 | Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 14 Apr 2014 | Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation. | Arrow International Inc | Device | Class II | 1 |
| 14 Apr 2014 | LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30 | Golden State Medical Supply Inc. | Drug | Class II | 1 |
| 14 Apr 2014 | Organic traditions DARK CHOCOLATE GOLDEN BERRIES***DAIRY & SUGAR FREE 80% DARK CHOCOLATE; Pack sizes 3.5oz/100g, UPC 8 54260 00263 8; 5.3 oz (150g), UPC 8 54260 00266 9; 12kg bulk boxes. | Health Matters America Inc. | Food | Class I | 2 |
| 14 Apr 2014 | Price Chopper brand Hummus TUSCAN WHITE BEAN, NET WT. 10 OZ. Labels applied to clear plastic container with black rim on lid. | Golub Corporation | Food | Class I | 2 |
| 14 Apr 2014 | Greens+ Vegan Crisp Bars - Dark Chocolate Almond Blueberry in 1.4 oz packages. | Orange Peel Enterprises, Inc. | Food | Class II | 3 |
| 11 Apr 2014 | AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 10 Apr 2014 | Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components. | Synthes, Inc. | Device | Class II | 1 |
| 10 Apr 2014 | enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen Lab Automation System is a modification to VITROS Analyzers that includes… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 10 Apr 2014 | Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's sideport permits access for administration… | Smiths Medical ASD, Inc. | Device | Class I | 1 |
| 10 Apr 2014 | VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use. | Ortho-Clinical Diagnostics | Device | Class II | 3 |
| 10 Apr 2014 | ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 7 |
| 10 Apr 2014 | Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02. | Wockhardt Usa Inc. | Drug | Class II | 1 |
| 9 Apr 2014 | Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system. | Cochlear Americas Inc. | Device | Class II | 1 |
| 9 Apr 2014 | Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61 (67978) | Legacy Pharmaceutical Packaging | Drug | Class II | 1 |
| 8 Apr 2014 | Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP). | Synthes, Inc. | Device | Class II | 1 |
| 7 Apr 2014 | SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy. (68039) | Small Bone Innovations, Inc. | Device | Class II | 1 |
| 3 Apr 2014 | Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while… (68293) | Bayer Corp | Device | Class II | 1 |
| 3 Apr 2014 | Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia | B. Braun Medical, Inc. | Device | Class II | 1 |
| 3 Apr 2014 | The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare… | GE Healthcare | Device | Class II | 1 |
| 1 Apr 2014 | Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners) | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 1 Apr 2014 | Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 31 Mar 2014 | Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common… (68279) | NEO METRICS, INC. | Device | Class II | 1 |
| 28 Mar 2014 | Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle,… | Integra LifeSciences Corporation | Device | Class II | 1 |
| 26 Mar 2014 | Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69. | Pharmakon Pharmaceuticals | Drug | Class I | 1 |
| 21 Mar 2014 | Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 21 Mar 2014 | ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 21 Mar 2014 | El Original pa' ya To Go by hot pandeyuca brand Soft Bread Pan Alinado | Hot Pandeyuca & Company Inc | Food | Class II | 3 |
| 20 Mar 2014 | enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 11 Mar 2014 | IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 6 Mar 2014 | Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9. | Greenstone Llc | Drug | Class I | 1 |
| 26 Feb 2014 | Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear (67740) | Wal Mart Stores, Inc | Device | Class II | 1 |
| 26 Feb 2014 | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 20 Feb 2014 | Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36… | ConMed Corporation | Device | Class II | 1 |
| 19 Feb 2014 | Harry & David; WILD 'N SPICY; DOS QUESOS DIP; NET WT 1 lb.; (453g);Mild; in glass jars; MADE FOR HARRY AND DAVID, MEDFORD OR, HARRYANDDAVID.COM; 800-547-3033 | Fischer & Wieser Specialty Foods | Food | Class II | 2 |
| 12 Feb 2014 | ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage:… | Abbott Laboratories | Device | Class II | 2 |
| 6 Feb 2014 | Vitamin D Milk GRADE A PASTEURIZED HOMOGENIZED; 4-oz paper, 300-gal totes, Gallons, 1/2 gallons, pints, quarts, paper 1/2 pints, 5-gal dispense bags. INGREDIENTS: MILK AND VITAMIN D3. Product is sold under the following brand names and UPC codes: American Fare: Gal: 0 72000 15233 1, ¿ Gal: 0 72000 15238 6; Community… (67841) | Borden Dairy Co Of Cincinnati Llc | Food | Class III | 1 |
| 29 Jan 2014 | GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1 | Pfizer Inc. | Drug | Class II | 1 |
| 24 Jan 2014 | LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration. | Hospira Inc. | Device | Class II | 3 |
| 24 Jan 2014 | REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC., Deltona, FL | MyNicNaxs, Inc. | Drug | Class I | 10 |
| 10 Jan 2014 | Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 8 Jan 2014 | 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165. | Cincinnati Sub-Zero Products Inc | Device | Class II | 1 |
| 23 Dec 2013 | Burn 7 Capsules, supplied in 30 capsules bottle (67162) | Individual firm, name withheld | Drug | Class I | 1 |
| 20 Dec 2013 | CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18 | Carefusion 2200 Inc | Drug | Class II | 2 |
| 19 Nov 2013 | vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148. (66839) | Vitality Research Labs LLC | Drug | Class I | 1 |
| 10 Oct 2013 | Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ | Pure Edge Nutrition | Drug | Class I | 6 |
| 10 Oct 2013 | Total Enzyme, Dietary Supplement, Nutri-West, 120 capsules, Servicing Size 1 Capsule | Nutrition Center, Inc. dba Nutri-West | Food | Class II | 2 |
| 7 Oct 2013 | CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment. (68266) | LAP of America Laser Applications, LLC | Device | Class II | 1 |
| 1 Oct 2013 | Tam Tams Snack Crackers Unsalted Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box | R.A.B. Food Group LLC | Food | Class III | 5 |
| 11 Sep 2013 | Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through magnification and illumination. | Leica Microsystems, Inc. | Device | Class II | 2 |
| 19 Jun 2013 | Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography | Beekley Corporation | Device | Class III | 1 |
| 4 May 2013 | NIPRO Safe Touch Safety Scalp Vein Set | Nipro Medical Corporation | Device | Class II | 1 |
| 5 Mar 2013 | Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor. | Philips Healthcare Inc. | Device | Class II | 1 |
| 5 Feb 2013 | Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use. | Cordis Corporation | Device | Class II | 1 |
| 31 May 2011 | BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device. | BioDerm, Inc. | Device | Class II | 3 |