| 7 Jan 2014 | AMS-530 7” Microbore Trifurcated Extension sets Product Usage: Intravascular administration set. | Churchill Medical Systems, Inc. | Device | Class II | 1 |
| 3 Jan 2014 | Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during… | Davol, Inc., Subs. C. R. Bard, Inc. | Device | Class II | 2 |
| 2 Jan 2014 | Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-84 | Pfizer Inc. | Drug | Class III | 1 |
| 27 Dec 2013 | Candy Place Chocolate Santas, in 11 oz clear plastic bags, individually wrapped assortment of double chocolate, caramel, and peanut butter flavored chocolates, distributed by Giant Eagle, Pittsburgh, PA. Ingredients: Sugar, partially hydrogenated vegetable oil (Palm kernel, coconut, and/or palm), cocoa (processed… Event 67185 | Name withheld | Food | Class I | 1 |
| 26 Dec 2013 | Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient. | Vital Signs Colorado Inc. | Device | Class II | 1 |
| 24 Dec 2013 | NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the… | ICU Medical, Inc. | Device | Class II | 50 |
| 23 Dec 2013 | Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05. | Watson Laboratories Inc | Drug | Class II | 1 |
| 20 Dec 2013 | Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical… | Zeiss, Carl Inc | Device | Class II | 1 |
| 20 Dec 2013 | Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is… Event 67150 | Optimedica Corporation | Device | Class II | 1 |
| 19 Dec 2013 | Weck, Electrosurgical Coagulation Suction Tube 6” (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770. Intended to remove tissue and control bleeding by use of high-frequency electrical current. | Teleflex Medical | Device | Class II | 2 |
| 19 Dec 2013 | Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 | Biomet, Inc. | Device | Class II | 1 |
| 19 Dec 2013 | On Site Gas Systems POGS 33C Portable Oxygen Generation System Event 67132 | On Site Gas Systems Inc. | Device | Class II | 1 |
| 19 Dec 2013 | Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty. | Zimmer, Inc. | Device | Class II | 2 |
| 18 Dec 2013 | Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon. | Boston Scientific Corporation | Device | Class II | 3 |
| 18 Dec 2013 | TopCare Clifford THE BIG RED DOG power toothbrush for kids! | Ranir Corporation | Device | Class II | 2 |
| 18 Dec 2013 | Organic Almonds: Baugher Ranch Organics; Certified Organic by California Organic Farmers May Contain occasional Shell fragments. Keep Refrigerated; 25 lbs. Baugher Farms, Orland, CA Event 67148 | Baugher Ranch Organics, Inc | Food | Class II | 1 |
| 18 Dec 2013 | Hood brand Fat Free Chocolate Milk, 8 oz. UPC: 0 44100 11244 7 | HP Hood LLC | Food | Class II | 1 |
| 18 Dec 2013 | SOLID MILK CHOCOLATE SANTA candy Event 67127 | Concertos In Chocolate LLC | Food | Class I | 1 |
| 17 Dec 2013 | Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 17 Dec 2013 | Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach cutting burrs are intended for cutting and… | The Anspach Effort, Inc. | Device | Class II | 4 |
| 16 Dec 2013 | Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients. | Covidien | Device | Class I | 1 |
| 16 Dec 2013 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) | GE Healthcare, LLC | Device | Class II | 1 |
| 16 Dec 2013 | STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments. | Advanced Sterilization Products | Device | Class II | 3 |
| 16 Dec 2013 | Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL). | Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 16 Dec 2013 | Fosforel Atlantika Herring Fillet in Oil (200 g) Product of Russia Imported by: Zip International Group LLC 160 Raritan Center Parkway, Unit 6 Edison, NJ 08837 UPC: 4607106577526 | Zip International Group LLC. | Food | Class I | 1 |
| 13 Dec 2013 | King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile Lubricant 32-5332 05/10 Intended for use in adult patients (in… | King Systems Corp. | Device | Class II | 1 |
| 13 Dec 2013 | DEL CAMPO PAPA SECA DRIED POTATO NET WT 14 OZ IMPORTED BY MEGABUSINESS PRODUCT OF PERU. UPC CODE 891726000218 Event 67089 | MEGABUSINESS LLC. | Food | Class I | 1 |
| 12 Dec 2013 | Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. | Hospira Inc. | Drug | Class II | 1 |
| 12 Dec 2013 | Candy Sweet Spots, 2oz. (3 display packages/case; 12-2oz packages/display case). UPC 0-73563-00471-6 Event 67077 | Bee International, Inc. | Food | Class I | 1 |
| 11 Dec 2013 | SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de l’Esplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 11 Dec 2013 | AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures | AdvanDx, Inc. | Device | Class III | 1 |
| 11 Dec 2013 | HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01. | KVK-Tech, Inc. | Drug | Class II | 3 |
| 11 Dec 2013 | Down Unders Cookie Mobile Meal sold under brand Down Unders, approximately 6.75 oz. (189 gram). Event 67105 | Cuisine Med. Catering | Food | Class II | 1 |
| 10 Dec 2013 | Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 10 Dec 2013 | Draeger Infinity Acute Care System Monitoring Solution | Draeger Medical Systems, Inc. | Device | Class II | 1 |
| 10 Dec 2013 | CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen… | Zimmer, Inc. | Device | Class II | 3 |
| 10 Dec 2013 | Antonina's Artisan Bakery brand, Gluten Free, Blueberry Mini Muffins, 12 pieces per package. Net wt. 12.6 oz. The UPC Code is 8 18703 01102 1. Event 67081 | Pin Hsiao & Associates | Food | Class I | 1 |
| 9 Dec 2013 | Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only | ArthroCare Medical Corporation | Device | Class II | 1 |
| 9 Dec 2013 | Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN and microspeed motor systems to hold burrs which cut and shape bone. | Aesculap, Inc. | Device | Class II | 1 |
| 6 Dec 2013 | Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal… | Lab Vision Corporation | Device | Class II | 1 |
| 6 Dec 2013 | Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into… | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 6 Dec 2013 | MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used… | Bard Access Systems | Device | Class II | 2 |
| 6 Dec 2013 | Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, Quick‐Connect Rx only, STERILE | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 6 Dec 2013 | Stuffed Foods Asiago Risotto Bites; UPC 850821-00301 | Stuffed Foods LLC | Food | Class II | 1 |
| 5 Dec 2013 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner.… | GE Healthcare, LLC | Device | Class II | 3 |
| 5 Dec 2013 | Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under… | CareFusion 303, Inc. | Device | Class I | 1 |
| 5 Dec 2013 | PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 5 Dec 2013 | Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 5 Dec 2013 | Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 5 Dec 2013 | Safeway Kitchens In Shell Edamame; Net Wt: 48 oz. (3 lb, 1.35Kg) 12 x 3 lb bags per case: Product of China: Packed in Canada Safeway, Pleasanton, CA. | Safeway Inc | Food | Class III | 1 |
| 5 Dec 2013 | Lobster Bisque, product 45036. Net WT 4.0 lbs. Keep Frozen. Event 67051 | Colony Brands, Inc. | Food | Class II | 1 |
| 5 Dec 2013 | Shredded Swiss Cheese, INGREDIENTS: Milk, Cheese Culture, Enzymes......Aged 60 days. CONTAINS: MILK NET WT. 80 OZ. (5 LB.) 2.2kg MFG By Biery cheese Co., Louisville, OH 44641 Event 67160 | Biery Cheese Co | Food | Class III | 1 |
| 4 Dec 2013 | ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 4 Dec 2013 | Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 4 Dec 2013 | Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9. | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 4 Dec 2013 | Joseph's Gourmet Pasta and Sauces- Asiago and Garlic Tortelloni (par cooked). Sold Frozen in 5 lb. plastic bags for food service Item Number: 22273 (G11008331) UPC Code: 00048769222738 Event 67033 | Nestle Prepared Foods Company | Food | Class II | 1 |
| 29 Nov 2013 | steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images. Event 66980 | Name withheld | Device | Class II | 1 |
| 27 Nov 2013 | GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. | GE Healthcare, LLC | Device | Class II | 1 |
| 27 Nov 2013 | 0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00. | B. Braun Medical Inc | Drug | Class II | 1 |
| 27 Nov 2013 | Diet Coke, 2L, 67.6 FL OZ (2 QT 3.6 FL OZ), UPC 4900005011 Event 67015 | Coca Cola Bottling Company United-East, LLC | Food | Class II | 1 |
| 27 Nov 2013 | Hot Smoked Wine Maple Salmon, Item HS-B, vacuum packaged and either frozen or refrigerated, ranging in size between about one pound to eight pounds. The UPC for net weight 0.445 lbs. is 0 240080 618023. The label is read in part: HOT SMOKED WINE-MAPLE SALMON SALMON, SALT, SUGAR, SOY, COOKING WINE, MAPLE FLAVORING,… | Name withheld | Food | Class II | 3 |
| 26 Nov 2013 | G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 | Biomet, Inc. | Device | Class II | 1 |
| 26 Nov 2013 | Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra„ Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial… | Integra LifeSciences Corp. d.b.a. Integra Pain Management | Device | Class II | 1 |
| 26 Nov 2013 | STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. | Advanced Sterilization Products | Device | Class II | 1 |
| 26 Nov 2013 | BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink injection site. It is screwed down over the Interlink injection site and a blunt plastic cannula inside the housing enters the Interlink injection site to provide a pathway for IV… | Becton Dickinson & Company | Device | Class II | 1 |
| 26 Nov 2013 | Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or Temperature… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 26 Nov 2013 | REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific… | Materialise USA LLC | Device | Class II | 1 |
| 26 Nov 2013 | Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal… | Stryker Medical Division of Stryker Corporation | Device | Class II | 2 |
| 26 Nov 2013 | Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 26 Nov 2013 | Phillips Food Service Lobster Bisque, 4 lb cryobag, frozen Item #45036 Event 66994 | Kettle Cuisine, Inc. | Food | Class II | 1 |
| 25 Nov 2013 | HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195… Event 66971 | Abbott Vascular, Inc. | Device | Class II | 1 |
| 25 Nov 2013 | REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic. | Smith & Nephew Inc | Device | Class II | 1 |
| 25 Nov 2013 | Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during… Event 66930 | C.L.R. Medicals International, Inc. | Device | Class I | 1 |
| 25 Nov 2013 | DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete… | Carestream Health, Inc. | Device | Class II | 3 |
| 25 Nov 2013 | XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a… | Elekta, Inc. | Device | Class II | 1 |
| 25 Nov 2013 | Fosforel Atlantika Herring Fillet in Oil 14.1 oz. (400 g) Product of Russia Imported by: Zip International Group LLC 160 Raritan Center Parkway, Unit 6 Edison, NJ 08837 UPC: 4607095500208 | Zip International Group LLC. | Food | Class I | 1 |
| 25 Nov 2013 | EstroPlus Maximum Strength Menopause Support Dietary Supplement in 28 count and 56 count blister strips under the following labels - CareOne Maximum Strength Multi Symptom Menopause Formula, 28 Caplets/Dietary Supplement; Meijer Maximum Strength Estroplus, Dietary Supplement, 28 Caplets; TopCare Maximum Strength… Event 66943 | Perrigo of SC | Food | Class II | 1 |
| 22 Nov 2013 | Pulmonary Hemi-Artery SG Used in heart surgery | CryoLife, Inc. | Device | Class II | 1 |
| 22 Nov 2013 | Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked and Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 count bottle: NDC: 54868-0816-8, 60 count bottle: NDC: 54868-0816-4, 30 count bottle: NDC: 54686-0816-3. | Physicians Total Care, Inc. | Drug | Class II | 1 |
| 22 Nov 2013 | Heavenly Blue, (Raw milk, salt, culture, coagulant ), Flat Creek Lodge, 367 Bishop Chapel Church Rd, Swainsboro, GA 30401. The raw milk blue cheese is packaged in clear plastic, with sizes ranging from 1/2 lb to whole wheels. | Flat Creek Farm & Dairy | Food | Class I | 1 |
| 21 Nov 2013 | Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | Ziehm Imaging Inc | Device | Class II | 7 |
| 21 Nov 2013 | Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility… | Remel Inc | Device | Class II | 1 |
| 21 Nov 2013 | Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient… Event 66996 | Name withheld | Device | Class II | 1 |
| 21 Nov 2013 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices,… | Steris Corporation | Device | Class II | 1 |
| 21 Nov 2013 | The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care… Event 66919 | Welch Allyn Protocol, Inc | Device | Class II | 1 |
| 21 Nov 2013 | Armanino Alfredo Sauce; Frozen in 10 oz x 12 pouches per case (sample, not for retail sale) and 3 lb. pouches 4 x 3 lb. pouches per case for food service use UPC - 10 oz. samples: 10041622 002635 UPC 3 lb. pouch: 10041622 019428 Distributed by Armanino Foods, Hayward, CA; Manufactured by Del Monaco Specialty Foods,… Event 66915 | Del Monaco Specialty Foods Inc. | Food | Class II | 1 |
| 20 Nov 2013 | ORCHESTRA/ORCHESTRA PLUS Programmer Event 67013 | Sorin Group Italia S.r.l. | Device | Class II | 1 |
| 20 Nov 2013 | Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures. | Edwards Lifesciences, LLC | Device | Class III | 1 |
| 20 Nov 2013 | Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position. | SpineFrontier, Inc. | Device | Class II | 4 |
| 20 Nov 2013 | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system. | SpineFrontier, Inc. | Device | Class II | 3 |
| 20 Nov 2013 | TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. | Boston Scientific Corporation | Device | Class II | 6 |
| 19 Nov 2013 | Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark | Asante Solutions, Inc. | Device | Class II | 8 |
| 19 Nov 2013 | Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum. | Atrium Medical Corporation | Device | Class II | 9 |
| 18 Nov 2013 | Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation. | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 16 Nov 2013 | Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691 Event 66889 | Tower Pharmacy and Compounding | Drug | Class II | 1 |
| 16 Nov 2013 | White bread packaged under the following names and sizes: UPC Name, size 71025-00269 Holsum, Sof-Twist, Giant, 24 OZ 24126-01025 Bunny, Thin Sandwich, 24 OZ 71302-04738 Sunbeam, KING, 24 OZ 71025-00512 Harts, HOME STYLE, 24 OZ 71025-00040 Lewis, CIRCLE B, Texas Toast, 24 OZ 71302-04745 Sunbeam, Texas Toast, 24 OZ… | Lewis Bakeries-Evansville | Food | Class II | 8 |
| 15 Nov 2013 | Wegman's Brand New England Clam Chowder (refrigerated at 38F or below) in a 16 oz plastic cup. | Blount Fine Foods Corporation | Food | Class II | 1 |
| 15 Nov 2013 | Organic Forbidden RICE RAMEN; Gluten Free/Vegan, Black Rice Noodles Ready in 4 minutes; Net Wt. 10 oz; (283 g) 4 ramen per bag USDA Organic; Lotus Foods, Richmond, CA. | Lotus Foods Inc | Food | Class II | 6 |
| 15 Nov 2013 | Chewable EnZym-Complete/DPPIV with Isogest, Kirkman brand. Item # 0934-090. | Kirkman Group Inc. | Food | Class II | 7 |
| 14 Nov 2013 | Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95. | Teva Pharmaceuticals USA, Inc. | Drug | Class III | 1 |
| 13 Nov 2013 | Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for… | Integra LifeSciences Corp. | Device | Class II | 2 |
| 13 Nov 2013 | RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit. | Instrumentation Industries Inc | Device | Class II | 1 |
| 12 Nov 2013 | Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The… | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 12 Nov 2013 | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical… | Ansell Sandel Medical Industries LLC | Device | Class II | 7 |
| 12 Nov 2013 | MegaFood High Active Enzymes - 30 count (Formula 10216) | FoodState (Nutrient Manufacturing) | Food | Class II | 6 |
| 12 Nov 2013 | Artichoke Wheatberry Salad: sold in prepackaged pint and half pint containers in the Prepared Foods Dept. as well as sold fresh from the Deli case and salad bar. | Whole Foods Market | Food | Class II | 2 |
| 9 Nov 2013 | USPlabs OxyELITE Pro Super Thermo DIETARY SUPPLEMENT Manufactured for USPlabs, LLC (Dallas, TX 75220), distributed in the following sizes: 2 count capsules; 10 count capsules; 21 count capsules; 90 count capsules; and 180 count capsules. | USPlabs, LLC | Food | Class I | 7 |
| 9 Nov 2013 | Delish Greek Style Orzo Salad; Traditional orzo, cucumber, red bell peppers, green onion and Kalamata olives tossed with a creamy Greek Style yogurt and feta dressing. 6 oz (170g) in clam shell plastic container. Packaged for Walgreens Manufactured by Glass Onion Catering, Richmond, CA. | Atherstone Foods Inc dba Glass Onion Catering | Food | Class II | 6 |
| 8 Nov 2013 | Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal diagnostic imaging system for radiographic and… | GE Healthcare, LLC | Device | Class II | 1 |
| 8 Nov 2013 | ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. | Materialise USA LLC | Device | Class II | 2 |
| 8 Nov 2013 | IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 8 Nov 2013 | Vega Sport Performance Protein Dietary Supplement Chocolate Powder. Distributed by: Sequel Naturals LTD, Burnaby, BC, Canada. Vegasport.com. Packaged in HDPE jars; in VFF pouch. 29oz/822g, 1.3 oz/36g, 17x1.3oz/36g pouches. | Vega / Sequel Naturals | Food | Class II | 8 |
| 7 Nov 2013 | EOS System X- ray beam Digital radiography system used in general radiographic examinations. Event 66833 | Name withheld | Device | Class II | 1 |
| 7 Nov 2013 | OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery. | OrthoPediatrics Corp | Device | Class II | 1 |
| 7 Nov 2013 | GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698. | GE Healthcare, LLC | Device | Class II | 1 |
| 6 Nov 2013 | Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004 Event 66754 | Data Innovations, Inc. | Device | Class II | 1 |
| 6 Nov 2013 | IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum,… | Siemens Healthcare Diagnostics | Device | Class II | 1 |
| 6 Nov 2013 | Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx only, 6 mg, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in Singapore, NDC 0173-0479-00 | GlaxoSmithKline, LLC. | Drug | Class II | 2 |
| 5 Nov 2013 | FEM COND BUTTRESS PLT, RT. | Zimmer, Inc. | Device | Class II | 8 |
| 5 Nov 2013 | sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1 | Greenstone LLC | Drug | Class II | 1 |
| 4 Nov 2013 | Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial… | Zimmer, Inc. | Device | Class II | 1 |
| 1 Nov 2013 | PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01 Event 66741 | Sigma-Tau Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 1 Nov 2013 | Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8 | Greenstone Llc | Drug | Class II | 1 |
| 1 Nov 2013 | IMT Wellness Legume Digest 2.0** Dietary Supplements 120 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT; in a white 150 cc bottle with white cap | ANAT, LLC | Food | Class II | 2 |
| 31 Oct 2013 | Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10. | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 30 Oct 2013 | Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 29 Oct 2013 | Self-Rising White Cornmeal Mix sold under the Aunt Jemima brand and packaged in a paper bag with a net weight respectively of 32 oz. (2 lb.) 907 g. or 5 lb. (2.26 kg.). | Quaker Foods and Snacks North America | Food | Class II | 4 |
| 28 Oct 2013 | Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16. | Hi-Tech Pharmacal Co., Inc. | Drug | Class III | 1 |
| 28 Oct 2013 | BROCCOLI, SLAW CRUNCH KIT, 390260, 1/6.55# | Taylor Farms Florida, Inc. | Food | Class II | 1 |
| 28 Oct 2013 | CabG Coleslaw Kit with Dressing TF 12.56#, 1400265, Net Weight: 12.5 Lbs, Ingredients: Green Cabbage, Carrots, Dressing; Distributed by Taylor Farms Texas, Dallas, TX 75211 | Taylor Farms Texas, Inc. | Food | Class II | 2 |
| 26 Oct 2013 | Diced Summer Slaw Salad Kit Fresh Food Manufacturing Company 10.5 lbs Event 66628 | Fresh Foods Manufacturing Co. | Food | Class II | 1 |
| 25 Oct 2013 | VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 25 Oct 2013 | Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region. | Civco Medical Instruments Inc | Device | Class II | 2 |
| 25 Oct 2013 | DICED SUMMER SLAW, 310140, TAYLOR FARMS 1/5.25, NET WT: 5 lbs; 2 PK, 310138, TAYLOR FARMS 2/1.25, NET WT: 10.5, TAYLOR FARMS, MD | Taylor Farms Maryland-Assateague Drive | Food | Class II | 5 |
| 22 Oct 2013 | Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01 | Sandoz Incorporated | Drug | Class II | 1 |
| 22 Oct 2013 | Macaroni Reg CAD, Formula MA.50, Macaroni Salad, packaged: -7-Eleven Fresh to Go Macaroni Salad, 12/7-oz carton cases. Distributed by 7-11, Inc., Dallas, TX. UPC 052548517571 -Reser's Fine Foods Macaroni Salad, 6/4-lb (UPC 071117001631) Party Pack, 3/8-lb (UPC 071117002164) and 6/1.25-KG (UPC 071117613223) carton… | Reser's Fine Foods, Inc. | Food | Class I | 213 |
| 19 Oct 2013 | Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | Specialty Medicine Compounding Pharmacy | Drug | Class II | 51 |
| 18 Oct 2013 | Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC… | Compounding Centre At Blue Ridge | Drug | Class II | 5 |
| 15 Oct 2013 | McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). | Mckesson Information Solutions LLC | Device | Class II | 1 |
| 15 Oct 2013 | ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark 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 |
| 14 Oct 2013 | Terrain Zyme Myco-Zyme (Z-13), Enzyme-Based Herbal Dietary Supplement, packaged as 90 capsules per bottle. Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606. | Innovative Labs, LLC | Food | Class II | 2 |
| 11 Oct 2013 | TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical… | Codman & Shurtleff, Inc. | Device | Class I | 2 |
| 11 Oct 2013 | BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C.… | Becton Dickinson & Co. | Device | Class II | 1 |
| 11 Oct 2013 | 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01. | Hospira Inc. | Drug | Class II | 1 |
| 11 Oct 2013 | Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus labels. NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-5233-91 (vial) | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 11 Oct 2013 | Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01, | Sandoz Inc | Drug | Class II | 1 |
| 10 Oct 2013 | Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood. | Nova Biomedical Corporation | Device | Class II | 1 |
| 10 Oct 2013 | Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009 Event 66695 | Airgas Medical Services | Drug | Class II | 1 |
| 7 Oct 2013 | C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and… | RTI Surgical, Inc. | Device | Class II | 1 |
| 7 Oct 2013 | Dexedrine (Dextroamphetamine Sulfate) Spansules Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09 Event 66593 | Amedra Pharmaceuticals LLC | Drug | Class II | 1 |
| 7 Oct 2013 | Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No. 10828-002-06, Cas No: 1115-70-4 Event 67155 | Betachem, Inc. | Drug | Class II | 1 |
| 5 Oct 2013 | Reser's Fine Foods, Cheesy Macaroni Salad, packaged in 454 gm (UPC 071117182415) and 1.25 KG (UPC 071117612271) plastic containers. | Reser's Fine Foods, Inc. | Food | Class I | 1 |
| 4 Oct 2013 | VITROS Chemistry Products COCM Reagent | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 30 Sep 2013 | Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery. | Stryker Howmedica Osteonics Corp. | Device | Class II | 2 |
| 30 Sep 2013 | G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080 | G & W Laboratories Inc | Drug | Class III | 1 |
| 27 Sep 2013 | B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular… | B. Braun Medical, Inc. | Device | Class II | 1 |
| 27 Sep 2013 | Pepper Smoked King Salmon. Product sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: "***BIG BLUE FISHERIES, LLC***Pepper Smoked King Salmon***Ingredients: Wild Alaskan Salmon, Water, Sugar, Salt,… | Big Blue Fisheries | Food | Class II | 11 |
| 26 Sep 2013 | Sitka Sound Seafoods Hickory Smoked Salmon (Coho, King, or Sockeye) is hot smoked salmon, vacuum packaged, random net weight. The product is labeled in parts: "***Sitka Sound Seafoods***329 Katlian St. Sitka, Ak. 99835***Hickory Smoked***Salmon***Ingredients: Wild Alaskan Coho Salmon, Water, Sugar, Salt, &… Event 66549 | North Pacific Seafoods, Inc. | Food | Class II | 1 |
| 24 Sep 2013 | Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle… | SpineFrontier, Inc. | Device | Class II | 3 |
| 20 Sep 2013 | The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity… Event 66603 | Midmark Corp dba Progeny Inc | Device | Class II | 1 |
| 17 Sep 2013 | Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-556-09 | Lupin Pharmaceuticals Inc. | Drug | Class II | 2 |
| 11 Sep 2013 | PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. | SpineFrontier, Inc. | Device | Class II | 1 |
| 10 Sep 2013 | VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes. | Steris Corporation | Device | Class II | 1 |
| 5 Sep 2013 | Gold Label Shrimp Dip in 7 oz plastic containers, Manufactured by Adelphia Seafood, ingredients: cream cheese (pasteurized milk & cream, cheese culture, salt, stabilizers (carob bean and/or xanthan gums), water, shrimp, surimi (fish protein (pollock, cod and/or pacific whiting), water, wheat/corn starch, natural crab… | Hahn, Harry O Seafood Inc | Food | Class III | 4 |
| 4 Sep 2013 | Nature Science Dym-Sdrol capsules, packaged as a bulk product in clear plastic bags. | Mira Health Products Ltd. | Food | Class II | 79 |
| 30 Aug 2013 | Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8. | Hospira Inc. | Drug | Class I | 1 |
| 29 Aug 2013 | Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray… | Carestream Health Inc. | Device | Class II | 1 |
| 29 Aug 2013 | Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum | Vital Diagnostics, Inc. | Device | Class II | 2 |
| 29 Aug 2013 | Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA | Cubist Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 27 Aug 2013 | Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended… | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | Device | Class II | 1 |
| 26 Aug 2013 | Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three dimensional image review,… | GE Healthcare It | Device | Class II | 1 |
| 22 Aug 2013 | Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number Event 66064 | Trans American Medical, Inc. | Device | Class II | 1 |
| 16 Aug 2013 | XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) Medical Food Distributed by Xymogen Orlando, Florida. Also sold and distributed under various brands and firms: *1. 4XLipidComplete (Omega-3 Phospholipid 540 mg) Medical Food Distributed by: N2 Health, La Quinta, CA. *2. AL Metabolic P Manufactured for Integrated Medical… | Atlantic Pro Nutrients, Inc. dba XYMOGEN | Food | Class III | 2 |
| 31 Jul 2013 | Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphate (AP)-linker antibody… Event 66030 | Leica Biosystems Newcastle Ltd. | Device | Class II | 1 |
| 12 Jul 2013 | The refrigerated vacuum packed hot smoked oysters, Original flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part "***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. #… | Name withheld | Food | Class II | 6 |
| 10 Jul 2013 | Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle… | Smiths Medical ASD, Inc. | Device | Class II | 5 |
| 2 Jul 2013 | ISOSORBIDE DINITRATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781155601. | Aidapak Services, LLC | Drug | Class II | 265 |
| 2 Jul 2013 | ZINC GLUCONATE, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904319160. | Aidapak Services, LLC | Drug | Class II | 273 |
| 18 Jun 2013 | Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3. Also packaged… | Novartis Consumer Health | Drug | Class II | 16 |
| 10 Jun 2013 | pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen). | Radiometer America Inc | Device | Class II | 1 |
| 7 Jun 2013 | Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 6 Jun 2013 | Creole & Company Creole Bisque, NET WEIGHT 3.47 oz (98g), manufacture for: Creole & Company, 145 Robert E. Lee Blvd. Penthouse Suite, New Orleans, LA 70124, UPC: 811773014869 Event 65373 | Creole & Company, LLC | Food | Class I | 1 |
| 4 Jun 2013 | Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 3 Jun 2013 | Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit… | Alere San Diego, Inc. | Device | Class II | 1 |
| 15 May 2013 | Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc.,… | Novartis Consumer Health | Drug | Class III | 7 |
| 6 May 2013 | Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 6 May 2013 | Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 29 Apr 2013 | Savory Hot Smoked Salmon is Farmed Raised product, Low salt, vacuum packaged. Savory Smoked Salmon produced by Jensen's Smokehouse is not sold as a vacuum packaged product to the consumer. Products are shipped with "Keep Frozen" sticker on a case label. The case label states ***HOT SMOKED SAVORY SALMON 3/3#… | Jensens Old Fashioned Smokehouse Inc | Food | Class II | 15 |
| 25 Apr 2013 | ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone. | The Anspach Effort, Inc. | Device | Class II | 4 |
| 22 Apr 2013 | HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 16 Apr 2013 | 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond… Event 64966 | Ziemer Usa Inc | Device | Class II | 1 |
| 15 Apr 2013 | Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 10 Apr 2013 | Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 9 Apr 2013 | Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the… | Remel Inc | Device | Class II | 4 |
| 12 Mar 2013 | The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data… | GE Healthcare It | Device | Class II | 1 |
| 27 Feb 2013 | FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA | Mutual Pharmaceutical Company, Inc. | Drug | Class III | 3 |
| 25 Jan 2013 | Puritan Bennett 840 Series Ventilator PB840 Operator’s Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The… | Nellcor Puritan Bennett Inc. (dba Covidien LP) | Device | Class II | 2 |
| 29 Nov 2012 | NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for and Distributed by NewMarket Health Products, LLC. 702 Cathedral St. Baltimore, MD 21201 Event 67088 | Mariposa Labs, LLC | Drug | Class II | 1 |
| 26 Oct 2012 | Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED… | The Anspach Effort, Inc. | Device | Class II | 1 |
| 15 Sep 2012 | Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also… | Ge Healthcare It | Device | Class II | 1 |
| 11 Jun 2012 | Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone. | The Anspach Effort, Inc. | Device | Class II | 2 |
| 16 Apr 2012 | Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user. | Invacare Corporation | Device | Class II | 1 |
| 29 Mar 2012 | Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures | The Anspach Effort, Inc. | Device | Class II | 1 |
| 29 Mar 2012 | Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. | The Anspach Effort, Inc. | Device | Class II | 21 |
| 9 Sep 2011 | Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only | The Anspach Effort, Inc. | Device | Class II | 1 |
| 4 Mar 2011 | Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data… | Ge Healthcare It | Device | Class II | 1 |