| 10 Nov 2015 | MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 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. | Codman & Shurtleff, Inc. | Device | Class II | 2 |
| 14 May 2014 | Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3. | Oasis Medical Inc | Drug | Class III | 1 |
| 12 May 2014 | Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30 | Forest Pharmaceuticals Inc | Drug | Class II | 1 |
| 9 May 2014 | CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535) | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 8 May 2014 | PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01 | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 5 May 2014 | Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting… | Philips Healthcare Informatics, Inc. | Device | Class II | 1 |
| 3 May 2014 | Purity Organic - Organic Mango Mango Tommy Atkins CAT 1, Size 07, 08, 10 and 12. Product of Mexico, Pacific.com distributed by: Pacific Organic Produce, San Francisco, CA 94080 Event 68194 | Pacific Organic Produce | Food | Class I | 1 |
| 2 May 2014 | Blue Bunny Premium Ice Cream, Bordeaux Cherry Chocolate, 1.75 quart. Packaged in 4/56-oz carton cases. Item # 745152, UPC 070640034123. Manufactured by Wells Enterprises, Inc., Le Mars, IA. | Wells Enterprises, Inc. | Food | Class I | 1 |
| 1 May 2014 | Lipton Pure Leaf Iced Tea Unsweetened 18.5OZ PL 6 Pack and 12 Pack | Pepsi Beverages Company | Food | Class II | 6 |
| 29 Apr 2014 | Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402. Event 68199 | Independent Nutrition Center, Inc. | Drug | Class II | 1 |
| 29 Apr 2014 | Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-Seine Cedex, barcode *3421357* | Flawless Beauty LLC | Drug | Class II | 6 |
| 29 Apr 2014 | Bolivian Artichoke Salad sold at Whole Foods 10 lb bulk bags, refrigerated | Whole Foods Market Group Inc. | Food | Class II | 1 |
| 28 Apr 2014 | Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR… | Greatbatch Medical | Device | Class II | 1 |
| 25 Apr 2014 | MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 25 Apr 2014 | Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K | Fresenius Medical Care Holdings, Inc. | Device | Class II | 2 |
| 25 Apr 2014 | Private Selection Chocolate Hazelnut Mascarpone Ice Cream, 16 fl oz lamented carton. Product labeled in part, "PRIVATE SELECTION" CHOCOLATE HAZELNUT MASCARPONE ICE CREAM chocolate covered hazelnuts folded into creamy mascarpone ice cream***INGREDIENTS: ICE CREAM MILK, CREAM SUGAR***MASCARPONE CHEESE (MILK, CREAM,… | Kroger Co | Food | Class I | 2 |
| 24 Apr 2014 | Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients. Event 68114 | Name withheld | Device | Class II | 1 |
| 24 Apr 2014 | Stonyfield YoBaby Pear/Peach Organic Whole Milk Yogurt multipack- 6 pack plastic cups- 3 peach and 3 pear/4 oz each cups UPC-052159701161 | Name withheld | Food | Class II | 3 |
| 23 Apr 2014 | Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or… Event 68223 | Heraeus Kulzer, LLC. | Device | Class II | 1 |
| 23 Apr 2014 | GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices. | GE Healthcare, LLC | Device | Class II | 1 |
| 23 Apr 2014 | Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to ozone occurs in a reaction cell excited… Event 68143 | William C. Domb, D.M.D., A Professional Corporation | Device | Class II | 1 |
| 23 Apr 2014 | Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous… | CareFusion 303, Inc. | Device | Class I | 1 |
| 23 Apr 2014 | QVAR (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 23 Apr 2014 | On cap 100% Spring Water Bottled at Aqua Filter Fresh, Inc., Pittsburgh, PA 15239 Source Boiling Spring, Oakland, MD 21550 On bottle side: Tyler Mountain Water & Coffee In 3 gallon and 5 gallon plastic bottles | Aqua Filter Fresh, Inc. | Food | Class II | 2 |
| 22 Apr 2014 | SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures. | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 22 Apr 2014 | ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant. | Biomet, Inc. | Device | Class II | 1 |
| 22 Apr 2014 | Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa. | SigmaPharm Laboratories LLC | Drug | Class II | 1 |
| 21 Apr 2014 | Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile. Event 68095 | Bausch & Lomb Inc- Greenville Solutions Plant | Device | Class II | 1 |
| 21 Apr 2014 | 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04. | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 21 Apr 2014 | Scale label printed with "EASTER BREAD NET WT 17oz (1.06lb)" UPC 0 77890 32431 8, packaged in clear plastic bag | Wegmans Food Markets, Inc. | Food | Class II | 1 |
| 18 Apr 2014 | RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care. | Med-Mizer, Inc. | Device | Class II | 3 |
| 18 Apr 2014 | Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. | Nellcor Puritan Bennett Inc. (dba Covidien LP) | Device | Class II | 1 |
| 18 Apr 2014 | Hickory Farms Farmstand Recipe Chipotle Ranch Sauce Net Weight 9 Ounces Event 68051 | Hickory Farms Inc | Food | Class I | 1 |
| 18 Apr 2014 | Hickory Farms Chipotle Ranch Sauce; 9 oz. clear plastic pinch waist bottle Event 68112 | Woeber Mustard Manufacturing Co Inc | Food | Class I | 1 |
| 17 Apr 2014 | McKesson Radiology-PACS. McKesson Radiology is a medical image and information 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 |
| 17 Apr 2014 | HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy. | Elekta, Inc. | Device | Class II | 1 |
| 16 Apr 2014 | 12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the… Event 68045 | Name withheld | Device | Class II | 1 |
| 16 Apr 2014 | Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis. | Gambro Renal Products, Incorporated | Device | Class II | 2 |
| 16 Apr 2014 | Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of… | Alere San Diego, Inc. | Device | Class I | 1 |
| 16 Apr 2014 | RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe Strip, Blue. H93890227 RAPIDFILL Syringe… | Baxter Corporation Englewood | Device | Class II | 1 |
| 16 Apr 2014 | HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including… | HeartWare Inc | Device | Class II | 1 |
| 15 Apr 2014 | Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The… | Fisher & Paykel Healthcare, Ltd. | Device | Class I | 1 |
| 15 Apr 2014 | Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family… | P&L Developments, LLC | Drug | Class III | 1 |
| 14 Apr 2014 | Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through… Event 68012 | Microline Surgical | Device | Class II | 1 |
| 14 Apr 2014 | TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue. Event 68074 | Tenex Health Inc | Device | Class II | 1 |
| 14 Apr 2014 | ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 14 Apr 2014 | phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02 | Fresenius Medical Care Holdings, Inc. | Drug | Class II | 1 |
| 14 Apr 2014 | Frozen Corkscrew Pasta and Creamy tomato Vodka Sauce meal, Net Wt 9oz Event 68064 | Dd Foodsolutions Inc. | Food | Class I | 1 |
| 11 Apr 2014 | NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020. | Blue Belt Technologies MN | Device | Class II | 1 |
| 11 Apr 2014 | Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B)… | Aaron Industries Inc | Drug | Class III | 1 |
| 11 Apr 2014 | PRIVATE SELECTION SWEET STRAWBERRY SORBET, Labeled in part: "INGREDIENTS: WATER, SUGAR***DISTRIBUTED BY, THE KROGER CO., CINCINNATI, OHIO 45232***SELL BY AUG 11 15 3948 00:48 LIA" 0 11110 52108 8 | Kroger Co | Food | Class I | 1 |
| 10 Apr 2014 | Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle 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 I | 1 |
| 10 Apr 2014 | Verdex Fresh Snow Peas packed in 10 pounds cartons, keep refrigerated, Lot # 2161100811 product from Guatemala Event 68108 | Harvest Sensations LLC | Food | Class III | 1 |
| 10 Apr 2014 | Pastene MAFALDINE 5, 16 oz cellophane bag Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7062 UPC: 066086070627 | The Pastene Companies Ltd. | Food | Class II | 24 |
| 9 Apr 2014 | GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location. | GE Healthcare, LLC | Device | Class II | 1 |
| 9 Apr 2014 | Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83 | Caraco Pharmaceutical Laboratories, Ltd. | Drug | Class III | 2 |
| 9 Apr 2014 | Bissinger's Dark Chocolate Bunny Ears, 1 oz, individually wrapped in clear plastic with an ingredient card insert and packaged in a 24-ct. "point of purchase" display case. UPC 846107009785 (individual unit UPC 846107009788) Product number 16593. Bissinger's Handcrafted Chocolatier, St. Louis, MO. Event 67952 | Karl Bissinger LLC | Food | Class I | 1 |
| 9 Apr 2014 | Fernandez True Chile Flavor, Medium Hot Chile Molido Puro, 4 oz. | Fernandez Chile Company, Incorporated | Food | Class I | 2 |
| 8 Apr 2014 | Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and… | Bio-Rad Laboratories, Inc. | Device | Class II | 1 |
| 7 Apr 2014 | PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established. Event 67950 | Laurimed LLC | Device | Class III | 1 |
| 7 Apr 2014 | GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. | GE Healthcare, LLC | Device | Class II | 1 |
| 7 Apr 2014 | Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25. | Piramal Critical Care, Inc. | Drug | Class II | 1 |
| 7 Apr 2014 | BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5. | Teva Pharmaceuticals USA | Drug | Class II | 2 |
| 7 Apr 2014 | Archer Farms Brand Chocolate Hazelnut Swirl Gelato (Italian Ice Cream), 30 FL OZ. plastic tub, frozen. Product of Italy UPC 085239-703618 Event 67992 | Sinco Inc. | Food | Class I | 1 |
| 5 Apr 2014 | TRADER GIOTTO'S CAESAR SALAD with Caesar Dressing, NET WT. 8/5 OZ (241g). Event 67946 | H Group | Food | Class I | 1 |
| 4 Apr 2014 | Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps. Event 68031 | Name withheld | Device | Class II | 1 |
| 4 Apr 2014 | TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207, 10 MM X 18 CM, 130 degree, (7) REF 71675208, 11.5… | Smith & Nephew Inc | Device | Class II | 2 |
| 4 Apr 2014 | Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters. | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 4 Apr 2014 | Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting. | BD Biosciences, Systems & Reagents | Device | Class II | 1 |
| 4 Apr 2014 | Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25 | Boehringer Ingelheim Roxane Inc | Drug | Class III | 2 |
| 4 Apr 2014 | RISING MOON ORGANICS BASIL ASIAGO PINE NUT PESTO RAVIOLI; 8 OZ PACKAGE (227g) Keep Frozen USDA Organic: Distributed by Rising Moon Organics 313 Iron Horse Way Providence, RI 02908 | Carmel Food Group, Inc. | Food | Class III | 1 |
| 3 Apr 2014 | syngo Imaging XS Syngo Imaging XS 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 Imaging XS also supports storage and archiving of… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 3 Apr 2014 | Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices. | Shimadzu Medical Systems | Device | Class II | 1 |
| 3 Apr 2014 | Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 3 Apr 2014 | the BREAD STOP Country White Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag. | Bread Stop Bakery, LLC | Food | Class III | 8 |
| 2 Apr 2014 | Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate… | GE Healthcare | Device | Class II | 5 |
| 2 Apr 2014 | ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE,… | Baxter Corporation Englewood | Device | Class I | 1 |
| 2 Apr 2014 | Soy Bean Cake Net Wt. 9. oz. Ingredient: Soybeans, water, salt, Soy sauce, Spice, Calcium Sulfate. Perishable, keep refrigerated. Fong Kee Tofu Inc. 1135 Revere Ave. San Francisco, CA 94124. Event 67951 | Fong Kee Tofu Co., Inc. | Food | Class II | 1 |
| 1 Apr 2014 | 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 1 Apr 2014 | PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures. | Ortho Development Corporation | Device | Class II | 1 |
| 1 Apr 2014 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1. | Wockhardt Usa Inc. | Drug | Class II | 1 |
| 1 Apr 2014 | Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2 Event 68098 | Genesis Pharmaceutical, Inc. | Drug | Class III | 1 |
| 1 Apr 2014 | PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10. Event 68052 | Konsyl Pharmaceuticals Inc | Drug | Class III | 1 |
| 1 Apr 2014 | Fish Oil Softgel Capsules in white High Density Poly-Ethylene bottles labeled in part: "Major [brand] Fish Oil Cholesterol Free 1000 MG *** 100 Softgels *** Distributed by Major Pharmaceuticals ***Livonia, MI 48150 USA ***". Event 67999 | Nutri-Force Nutrition, Inc. | Food | Class II | 1 |
| 28 Mar 2014 | "Emparedados Boricua, Pollo & Queso (Chicken & Cheese), Net Wt. 6.5 oz, Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956" | Name withheld | Food | Class I | 4 |
| 28 Mar 2014 | Fresh Express, Italian, Crunchy Romaine Lettuce and Red Cabbage Salad, 10oz clear plastic bags, UPC: 71279-21100. Event 67877 | Chiquita Brands International, Inc. | Food | Class I | 1 |
| 28 Mar 2014 | Swanson Full Spectrum Cilantro (Coriander) Herbal Supplement, 60 capsules, 425 mg, SW1112. UPC 87614-11112 | Swanson Health Products, Inc | Food | Class I | 1 |
| 27 Mar 2014 | INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the… | INO Therapeutics (dba Ikaria) | Device | Class II | 1 |
| 27 Mar 2014 | Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 07206 Event 67880 | Deb-El Food Products, LLC. | Food | Class I | 1 |
| 26 Mar 2014 | VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY | Ortho-Clinical Diagnostics | Device | Class II | 2 |
| 26 Mar 2014 | The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage:… | Acumed LLC | Device | Class II | 2 |
| 26 Mar 2014 | Meijer Baby Pediatric Electrolyte Fruit Flavor 8oz x 4 with Best by: 10/01/15; 24 bottles per case, 6-4packs | H:20 Innovations LLC | Food | Class II | 2 |
| 25 Mar 2014 | Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 25 Mar 2014 | AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender. Event 67986 | AlloSource, Inc. | Device | Class II | 1 |
| 25 Mar 2014 | LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage | Hospira Inc. | Device | Class II | 5 |
| 25 Mar 2014 | Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA Event 67846 | First Aid Only Inc | Drug | Class II | 1 |
| 25 Mar 2014 | Holiday Foods, Cheddar Cheese Puffs, 4800308, UPC 70220748003081, 100 PCS, Not Fully Cooked - Cook Before Eating, Keep Frozen, For Institutional Use Only, Prepared by Holiday Food Inc, Hollywood, Florida 33020. | Schwan's Global Supply Chain, Inc. | Food | Class I | 2 |
| 24 Mar 2014 | GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05 | Teva Pharmaceuticals USA | Drug | Class II | 4 |
| 21 Mar 2014 | Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures. | Maquet Datascope Corp - Cardiac Assist Division | Device | Class I | 1 |
| 21 Mar 2014 | 2372 HOT & SPICY; 4 pound plastic gallon containers; UPC 0 9093912372 7 | Gold Medal Products | Food | Class III | 1 |
| 20 Mar 2014 | Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body. | Medline Industries Inc | Device | Class II | 1 |
| 20 Mar 2014 | Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of congestive heart… | Alere San Diego, Inc. | Device | Class II | 1 |
| 20 Mar 2014 | Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1. | Apotex Inc. | Drug | Class III | 1 |
| 20 Mar 2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202;… | Caraco Pharmaceutical Laboratories, Ltd. | Drug | Class II | 2 |
| 19 Mar 2014 | Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance. | RM Temena GmbH | Device | Class II | 2 |
| 19 Mar 2014 | Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery. Event 68093 | Biorep Technologies | Device | Class II | 1 |
| 19 Mar 2014 | Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 19 Mar 2014 | DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction. | Zimmer, Inc. | Device | Class II | 4 |
| 18 Mar 2014 | JK Bariatric Beds, True Air Technologies, Inc. | SCM True Air Technologies LLC | Device | Class II | 3 |
| 18 Mar 2014 | Losurdo IMPORTED GRATED PECORINO ROMANO, NET WT. 80 OZ. (5 LB.) 2.27 Kg, UPC 0 75009 00232 4. Product packaged within black plastic bag, with 5 bags per carton (20 LB) total per carton. Distributor LOSURDO FOODS, INC. 20 Owens Roads Hackensack, NJ 07601. Event 67765 | Losurdo Foods Inc | Food | Class II | 1 |
| 17 Mar 2014 | Phosphatidylcholine Solution for Injection, 50 mg/ mL, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203. | John W Hollis Inc | Drug | Class II | 4 |
| 17 Mar 2014 | Adult Herbal Blend 992 Item #H039 30 KGS PO#33590 Raw Deal Inc. PO Box 412 Allamuchy, NJ 07820 Phone: 973-347-6400 Fax: 973-347-5999 www.raw-deal.net | Name withheld | Food | Class I | 3 |
| 14 Mar 2014 | InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty. Event 67964 | InterValve Inc | Device | Class II | 1 |
| 13 Mar 2014 | Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05 | Blu Pharmaceuticals Inc | Drug | Class II | 2 |
| 13 Mar 2014 | REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original. Event 67726 | Pain Free By Nature | Drug | Class I | 1 |
| 11 Mar 2014 | Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation. | Teleflex Medical | Device | Class II | 7 |
| 11 Mar 2014 | CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137. | Teleflex Medical | Device | Class II | 2 |
| 10 Mar 2014 | Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 10 Mar 2014 | Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field. | Integra LifeSciences Corp. | Device | Class II | 1 |
| 10 Mar 2014 | Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3346-03, UPC 3… | AbbVie Inc | Drug | Class II | 5 |
| 7 Mar 2014 | Organic Basil 2.5 oz | Infinite Herbs, LLC | Food | Class I | 1 |
| 6 Mar 2014 | Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia,… | Pfizer Us Pharmaceutical Group | Drug | Class I | 1 |
| 5 Mar 2014 | Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel” Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs. | Alfa Wassermann, Inc. | Device | Class II | 2 |
| 5 Mar 2014 | DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation… | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 27 Feb 2014 | Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703), Itrel 4 (37704), RestorePrime (37701),… | Name withheld | Device | Class II | 3 |
| 26 Feb 2014 | Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter. Event 67720 | Name withheld | Device | Class II | 1 |
| 24 Feb 2014 | ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET… | Brainlab AG | Device | Class II | 1 |
| 20 Feb 2014 | VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease. | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 18 Feb 2014 | ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb. | Siemens Healthcare Diagnostics | Device | Class II | 1 |
| 18 Feb 2014 | GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX. | Hospira Inc. | Device | Class I | 1 |
| 14 Feb 2014 | Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5. Event 67526 | Legacy Pharmaceutical Packaging | Drug | Class II | 1 |
| 14 Feb 2014 | Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02 | Ben Venue Laboratories Inc | Drug | Class I | 1 |
| 12 Feb 2014 | Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland;… | Teva Pharmaceuticals USA | Drug | Class II | 2 |
| 11 Feb 2014 | Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11 | Baxter Healthcare Corp. | Drug | Class I | 1 |
| 7 Feb 2014 | PDP reads in part "***GOOD FOOD MADE SIMPLE***breakfast in a bowl *** SOUTHWESTERN VEGGIES***" UPC 0 80618 41801 5 | J. R. Simplot Co. Corporate HQ | Food | Class III | 1 |
| 5 Feb 2014 | Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab,… Event 67786 | Fisher Scientific Co | Device | Class II | 1 |
| 29 Jan 2014 | SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for… Event 67970 | Name withheld | Device | Class II | 1 |
| 13 Jan 2014 | PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA Event 67265 | HUMAN SCIENCE FOUNDATION | Drug | Class I | 1 |
| 13 Jan 2014 | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889 | Merck & Co Inc | Drug | Class III | 4 |
| 9 Jan 2014 | XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL. | Schindele Enterprises dba Midwest Wholesale | Drug | Class I | 7 |
| 8 Jan 2014 | ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 27 Dec 2013 | Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703. | Mangiacotti | Drug | Class II | 6 |
| 23 Dec 2013 | Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05. | Hospira Inc. | Drug | Class I | 1 |
| 20 Dec 2013 | IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in… | Siemens Healthcare Diagnostics | Device | Class II | 2 |
| 20 Dec 2013 | IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of… | Siemens Healthcare Diagnostics | Device | Class II | 2 |
| 3 Dec 2013 | Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 21 Nov 2013 | Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11 | B. Braun Medical Inc | Drug | Class I | 12 |
| 19 Nov 2013 | P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466 | Tendex | Drug | Class I | 2 |
| 7 Nov 2013 | Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com. Event 66817 | Name withheld | Drug | Class I | 1 |
| 4 Nov 2013 | Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50). Used to collect mucus specimens during suction… | Medline Industries Inc | Device | Class II | 1 |
| 31 Oct 2013 | Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers. | Hospira Inc. | Device | Class I | 2 |
| 21 Oct 2013 | Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc. Irving, TX, 75063, USA NDC 38779-2673-1, NDC… | Medisca Inc. | Drug | Class I | 1 |
| 27 Sep 2013 | GOOD TASTE brand Plum, 10.5 OZ, PRODUCT OF CHINA, UPC 3 867320 507650 --- AMERICA MANDY STAR TRADING Event 66427 | Mandy Star Trading Inc | Food | Class I | 1 |
| 19 Jul 2013 | Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060 | Herbal Give Care Llc | Drug | Class I | 5 |
| 17 Jul 2013 | Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF. | Arrow International Inc | Device | Class II | 1 |
| 26 Apr 2013 | Kaija Ivasi Lightly Salted Herring Fillets in Oil UPC 3585600709 | Zip International Group LLC. | Food | Class II | 1 |
| 26 Feb 2013 | CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946. | Siemens Healthcare Diagnostics Inc | Device | Class III | 1 |
| 29 Jun 2012 | MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator Event 67958 | Fujifilm Medical System USA, Inc. | Device | Class II | 1 |
| 23 Dec 2011 | SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000. | SpineFrontier, Inc. | Device | Class II | 1 |