| 5 Sep 2014 | Avocados, PLU#4770, size 32, 32 pcs/case. Packed in boxes with green, yellow, and red print with a black and white label. (69193) | Calavo Growers, Inc. (Corporate) | Food | Class I | 1 |
| 4 Sep 2014 | Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use. | Teleflex Medical | Device | Class II | 1 |
| 4 Sep 2014 | Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02 | Hospira Inc. | Drug | Class II | 1 |
| 28 Aug 2014 | TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System. (69113) | Motion Concepts | Device | Class II | 1 |
| 28 Aug 2014 | Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) container, Solace International, Inc., Reno, NV 89509, USA | Solace International Inc | Drug | Class II | 2 |
| 27 Aug 2014 | Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013 | Sage Products Inc | Drug | Class II | 1 |
| 27 Aug 2014 | OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21 | Qualitest Pharmaceuticals | Drug | Class II | 1 |
| 27 Aug 2014 | Dole Spinach: Thoroughly Washed, Preservative Free Net Wt. 8 oz. bag; Perishable, keep refrigerated. UPC 071430009765 SKU 320 Dole Fresh Vegetables Monterey, CA 93940 | Dole Fresh Vegetables Inc | Food | Class I | 2 |
| 26 Aug 2014 | Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 26 Aug 2014 | ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012… | Bio-Detek, Inc. | Device | Class II | 3 |
| 25 Aug 2014 | Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin. | Beckman Coulter Inc. | Device | Class II | 1 |
| 25 Aug 2014 | Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3. | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class III | 1 |
| 25 Aug 2014 | Activia Lowfat Yogurt Blueberry 4 x 4oz, Form Fill Seal plastic cups. (69110) | The Dannon Company, Inc - Discovery & Innovation Center | Food | Class III | 1 |
| 21 Aug 2014 | Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9 | Apotex Corp. | Drug | Class III | 1 |
| 21 Aug 2014 | Lean Cuisine Culinary Collection Chicken with Peanut Sauce. Packaged in 9 oz (255g) Plastic Tray in Fiberboard Carton 12 cartons per case by Nestle USA, INC, Solon, OH 44139 USA. (68942) | Nestle USA, Inc. | Food | Class I | 1 |
| 20 Aug 2014 | CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005. (69076) | ChiroNutraceutical LLC | Drug | Class III | 1 |
| 19 Aug 2014 | Siemens CentraLink Data Management System, software version 14. 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. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 19 Aug 2014 | Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409. | St Jude Medical Cardiac Rhythm Management Division | Device | Class II | 1 |
| 19 Aug 2014 | Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons, Distributed by: CVS… (69048) | Perrigo Holland Inc | Drug | Class III | 1 |
| 18 Aug 2014 | 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 18 Aug 2014 | FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation. | Elekta, Inc. | Device | Class II | 1 |
| 18 Aug 2014 | Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given… | Elekta, Inc. | Device | Class II | 1 |
| 18 Aug 2014 | Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 15 Aug 2014 | ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen… | Data Innovations, LLC | Device | Class II | 1 |
| 15 Aug 2014 | Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension. | Medtronic Cardiovascular Surgery-the Heart Valve Division | Device | Class II | 1 |
| 15 Aug 2014 | Thien Minh Cashew Kernels, Net Wt. 50 lb. Product of Vietnam | Specialty Commodities, Inc. | Food | Class I | 1 |
| 13 Aug 2014 | ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379,… | Siemens Healthcare Diagnostics | Device | Class II | 2 |
| 13 Aug 2014 | JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an… (69032) | Individual firm, name withheld | Device | Class III | 1 |
| 13 Aug 2014 | Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data. | Volcano Corporation | Device | Class II | 1 |
| 13 Aug 2014 | V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 13 Aug 2014 | McCormick Ground Oregano in 0.75 oz plastic bottle. UPC NUMBER: 52100003566 (as seen on label: 0-523561-6) MCCORMICK ITEM NUMBER: 900356 (69044) | McCormick & Company, Inc. | Food | Class I | 1 |
| 12 Aug 2014 | AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 12 Aug 2014 | PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158). Skin stapler for use in a single… | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 11 Aug 2014 | Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress, Prime Care ¿ Transcend Advanced Perimeter Mattress, Prime Plus ¿ Bariatric Mattress and Prime Plus ¿ Bariatric Perimeter Mattress, individual units packaged seperately. Model Numbers: TCM3576,… | Primus Medical LLC | Device | Class II | 1 |
| 11 Aug 2014 | LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group | Datascope Corporation | Device | Class III | 1 |
| 8 Aug 2014 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5… | GE Healthcare, LLC | Device | Class II | 1 |
| 8 Aug 2014 | Avocados approximately 14-30 oz each in packed 20 units in cardboard boxes with black lettering labeled in part: in part: "USDA/FL 2/196 LOT# 2610". (67993) | Brooks Tropicals, LLC | Food | Class I | 1 |
| 7 Aug 2014 | PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J +6MM; and | Zimmer, Inc. | Device | Class II | 6 |
| 6 Aug 2014 | ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on… | Siemens Healthcare Diagnostics | Device | Class II | 1 |
| 6 Aug 2014 | B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. | B. Braun Medical, Inc. | Device | Class II | 1 |
| 6 Aug 2014 | iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery. (69021) | Ellex iScience, Inc. | Device | Class II | 1 |
| 5 Aug 2014 | DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed. (69066) | Catheter Connections, Inc. | Device | Class II | 1 |
| 5 Aug 2014 | CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The… (68961) | Curbell Medical, Inc. | Device | Class II | 1 |
| 4 Aug 2014 | Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients. | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 4 Aug 2014 | RegeneSlim Appetite Control, 2 capsules/ packet, Dietary Supplement (68981) | Regeneca, Inc | Food | Class II | 1 |
| 3 Aug 2014 | Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric. (68997) | EMG Technology Co., Ltd. | Device | Class II | 1 |
| 1 Aug 2014 | CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery. | Civco Medical Instruments Inc | Device | Class II | 1 |
| 1 Aug 2014 | Clover, Crimson, Net Wt. 50 LB. PRODUCT OF USA, International Specialty Supply, 1011 Volunteer Drive, Cookeville, TN 28506 | International Sprout Holding Inc. | Food | Class I | 1 |
| 1 Aug 2014 | Ortho Molecular Products LifeCORE, Rich Dark Chocolate, Dietary Supplement Net Wt. 732.2 Grams (25.8Oz), Product #927001, UPC 15033-00927 | Ortho Molecular Products Inc | Food | Class I | 2 |
| 31 Jul 2014 | Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 31 Jul 2014 | Lacteos Santa Martha Quesito Casero Fresh Curd Net Weight 12oz Distributed by Oasis Brands Inc., Miami FL 33192 (68958) | Oasis Brands, Inc | Food | Class I | 1 |
| 30 Jul 2014 | Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made. | Zimmer, Inc. | Device | Class II | 1 |
| 30 Jul 2014 | Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization… | Integra York PA, Inc | Device | Class II | 1 |
| 30 Jul 2014 | Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis. | Zimmer, Inc. | Device | Class II | 1 |
| 30 Jul 2014 | CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic | Wright Medical Technology, Inc. | Device | Class II | 9 |
| 30 Jul 2014 | 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03 | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 29 Jul 2014 | Sunburst SUPERFOODS ORGANIC RAW CAROB POWDER in ONE POUND and 5 POUNDS bags --- Firm on label: SunburstSuperfoods.com Clifton, NJ (old label) and SunburstSuperfoods.com Tuckahoe, NY (new label) (68964) | Super Organic Foods, Inc | Food | Class I | 1 |
| 28 Jul 2014 | RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data. | Radiometer America Inc | Device | Class II | 1 |
| 28 Jul 2014 | Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging… | Illumina Inc | Device | Class II | 1 |
| 28 Jul 2014 | BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial. | Becton Dickinson & Co. | Device | Class II | 1 |
| 28 Jul 2014 | Swanson 100% Certified Organic, Carob Powder, Raw Chocolate Substitute, Net wt 1 lb (454 grams), in round 1000 cc High Density Poly-ethylene plastic containers, Product of Italy, Distributed by Swanson Health Products, PO Box 2803, Fargo ND 58108 USA, SWF115. | Swanson Health Products, Inc | Food | Class I | 1 |
| 27 Jul 2014 | Organic Carob Powder, 1 lb., 20 lb., and 55 lb. bags Expiry date: 6/5/2015, UPC Code 803813-04429-8 (68907) | Individual firm, name withheld | Food | Class I | 1 |
| 25 Jul 2014 | SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin. | JK Products & Services, Inc | Device | Class II | 1 |
| 25 Jul 2014 | ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a… | OrthoPediatrics Corp | Device | Class II | 1 |
| 25 Jul 2014 | GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature. | Galt Medical Corporation | Device | Class II | 2 |
| 25 Jul 2014 | Organic Raw Carob Powder is shipped in original twenty pound case from supplier or re-packaged and sold in five pound plastic bags. Five pound bags are labeled in part "OG RAW CAROB POWDER*** C110-5# Lot: *** 5 lbs***Distributed by Hummingbird Wholesale Eugene, OR 97401 Certified Organic by Oregon Dept. of… | Honey Heaven Wholesale, Inc. | Food | Class I | 1 |
| 25 Jul 2014 | Rising Moon Organics Butternut Squash Ravioli, Organic, Vegetarian & Delicious; Keep Frozen; Net Wt. 8 oz. UPC: 7-85030-55557-6. Manufactured for Rising Moon Organics. Manufactured by: Carmel Food Group, Hayward, CA | Carmel Food Group, Inc. | Food | Class II | 1 |
| 25 Jul 2014 | Green Vibrance- A Comprehensive Restorative Advanced Daily Superfood (Dietary Supplement) packaged as follows: A. 15-day, 181.5g, 6.4 oz. powder- Product Code GV15; B. 30-day, 363g, 12.8 oz. powder; Product Code GV 30; C.60-day, 726g, 25.61 oz. family size powder, -Product Code GV60; D. Bulk Supply Kilo Canister, 1… | Vibrant Health | Food | Class I | 4 |
| 25 Jul 2014 | Tiny Isle Chocolate Truffles: Gluten Free, Raw, Vegan; Sold in 4 pack box - 4 oz: Flavors: Sea Salt, Coconut, Macadamia Nut, Mint Crunch Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 | Florimont, Inc. | Food | Class I | 14 |
| 24 Jul 2014 | Raw Milk Mild Cheddar Cheese, in 8 oz, (UPC 79004-10002) and 5 lb. (no UPC) size packages. (68933) | SW Wisconsin Dairy Goat Products Coop | Food | Class I | 1 |
| 24 Jul 2014 | Puratos Chocolante, Dark Organic 1M Chip, Item Number 0065064002SH11, Net Weight: 25 lbs. (68968) | Puratos Chocolate USA | Food | Class I | 1 |
| 24 Jul 2014 | Avocados Simmons in white cardboard flats with black lettering "FLORIDA AVOCADO US COMB" 10 count (68975) | Homestead Pole Bean Cooperative, Inc. | Food | Class I | 1 |
| 24 Jul 2014 | gomacro MACROBAR brand almond butter + carob. Net Wt. 2 oz (57 g) | GoMacro, Inc. | Food | Class I | 2 |
| 23 Jul 2014 | The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie. | Becton Dickinson & Co. | Device | Class II | 1 |
| 23 Jul 2014 | Brown carob powder packed in a plastic heat sealed 16oz. bag, labeled in part "Live Superfoods Carob Powder***NET WT 16 OZ***Live Superfoods Bend, Oregon". UPC code 797734313543 The product also sold in 10 lbs. bags. (68990) | Individual firm, name withheld | Food | Class I | 1 |
| 22 Jul 2014 | Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM | Zimmer, Inc. | Device | Class II | 7 |
| 22 Jul 2014 | Organic Carob Powder; Certified Organic, Product of Italy. Store in Cool, Dark place. Packaged in 16 oz., 5 lb., 20 lb and 55 lb. containers. 16 oz.. - 6 per case; 5 lb. - 6 per case; 20 lb. - 2 per case; 55 lb. - 1 per case. Earth Circle Organics; Grass Valley, CA (68875) | River Canyon Retreat | Food | Class I | 1 |
| 21 Jul 2014 | Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.). (69057) | GF Health Products, Inc./d.b.a.Basic American Metal Products | Device | Class II | 1 |
| 21 Jul 2014 | JSF Ground Tuna - IQF - Origin: Indonesia - 2/11LB, frozen (68861) | Japanese Specialty Food Distributors Ltd, Co. | Food | Class II | 1 |
| 18 Jul 2014 | Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on… | Diagnostica Stago, Inc. | Device | Class III | 1 |
| 18 Jul 2014 | Whole Foods Market Chocolate Chewies Cookies in clamshell packaging, sold by the lb. Item # 6126 | Whole Food Market | Food | Class I | 1 |
| 17 Jul 2014 | CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including but not limited to, wire… | Cook Inc. | Device | Class I | 1 |
| 17 Jul 2014 | Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion | Genesis BPS, LLC. | Device | Class II | 3 |
| 16 Jul 2014 | Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 15 Jul 2014 | AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543. | Ab Sciex | Device | Class II | 1 |
| 14 Jul 2014 | ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter with***Retractable Collar***Fluid path is Sterile, Nonpyrogenic***Indications for Use: For the administration of fluids from a container into the patient's vascular system through a… | Baxter Healthcare Corp | Device | Class II | 3 |
| 11 Jul 2014 | Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. | Amerx Health Care Corp. | Device | Class II | 4 |
| 11 Jul 2014 | 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. | Baxter Healthcare Corp. | Drug | Class I | 3 |
| 10 Jul 2014 | Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter. | Zimmer, Inc. | Device | Class II | 4 |
| 8 Jul 2014 | Choripdong Chocolate Almond Richmond Ice Bar 4 bars/432 mL Seoul Trading USA Inc., Englewood NJ 07631 code # IC2006 and upc code: 761898669792 (68972) | Seoul Shik Poom, Inc. | Food | Class I | 1 |
| 7 Jul 2014 | Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 7 Jul 2014 | Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered… | Individual firm, name withheld | Device | Class II | 2 |
| 7 Jul 2014 | 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit | Smiths Medical ASD, Inc. | Device | Class I | 6 |
| 5 Jul 2014 | VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK | Device | Class II | 1 |
| 3 Jul 2014 | CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography. | CooperSurgical, Inc. | Device | Class II | 1 |
| 3 Jul 2014 | BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells. | Becton Dickinson & Company | Device | Class II | 1 |
| 2 Jul 2014 | ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment. | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 2 Jul 2014 | EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted. | Mentor Texas, LP. | Device | Class II | 1 |
| 1 Jul 2014 | Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01 | American Health Packaging | Drug | Class I | 2 |
| 27 Jun 2014 | Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality. (69043) | Life Force of Tampa, LLC | Device | Class II | 1 |
| 26 Jun 2014 | Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. | Hill-Rom, Inc. | Device | Class II | 1 |
| 25 Jun 2014 | Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature. | Concentric Medical Inc | Device | Class II | 1 |
| 25 Jun 2014 | BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration. | Biomet 3i, LLC | Device | Class II | 1 |
| 24 Jun 2014 | Marjon Alfalfa Sprouts, Pre-Washed Ready to Eat: Keep Refrigerated. NET WT. 6/4 oz. packaged in cups and bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 20077554000231. Used by 7/06/14. | Marjon Specialty Foods, Inc. | Food | Class II | 4 |
| 23 Jun 2014 | Cordis EMPIRA NC RX PTCA Dilatation Catheter | Cordis Corporation | Device | Class II | 2 |
| 23 Jun 2014 | BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 6 |
| 20 Jun 2014 | Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11. | Novel Laboratories, Inc. | Drug | Class III | 1 |
| 19 Jun 2014 | Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05. | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 19 Jun 2014 | Fresh Atlantic Salmon. No finished packaging. Fresh Salmon is placed in white styrofoam box and delivered to area restaurants. | CT Concerns, Inc. | Food | Class II | 2 |
| 17 Jun 2014 | C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide… | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 17 Jun 2014 | GONG XIFACAI GIFT CHOCOLATES, 238 grams, UPC 6 934169 900335 --- MANUFACTURER: JIANGXI GOLDEN EAGLE FOOD CO. LTD, ADD: NO. 188, YONGQIANG ROAD (NORTH), WANGCHENG TOWN, XINJIAN COUNTY, JIANGXI, CHINA 330100 --- The product is packed in a plastic tray with a plastic overwrap package. | Domega NY International Co Ltd | Food | Class I | 1 |
| 13 Jun 2014 | Shoprite Spring Water Net 1 GAL (120 Fl Oz.) 3.78L Distributed by Wakefern Food Corp Elizabeth, NJ Made in USA UPC 041190007196 | Readington Farms Inc. | Food | Class II | 2 |
| 12 Jun 2014 | La Finquita Quesito Fresco Campesino / Fresh Farmers Cheese. The product is packaged in a 14.11oz. plastic container, UPC Code: 0 94922 76809 4 (68542) | Individual firm, name withheld | Food | Class II | 1 |
| 10 Jun 2014 | Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to be used with the patient type who: sits… (68113) | ARJOHUNTLEIGH POLSKA SP. ZO.O. | Device | Class II | 1 |
| 2 Jun 2014 | ORGANIC TRADITIONS SPROUTED CHIA SEED POWDER NET WT. 8 oz. and 16 oz., UPC 854260006162, item number AHM616 and UPC 854260005462, item number AHM546 | Health Matters America Inc. | Food | Class I | 5 |
| 28 May 2014 | PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 | Central Admixture Pharmacy Services, Inc. | Drug | Class I | 4 |
| 20 May 2014 | Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel clamp, femoral angiography drape,needle 18G,&… | Customed, Inc | Device | Class I | 233 |
| 12 May 2014 | COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vial Rx Only Distributed by Bristol Meyers Squibb Company, Princeton, NJ 08543 USA NDC 0590-0324-96 (68276) | Individual firm, name withheld | Drug | Class I | 1 |
| 6 May 2014 | Ultraslim. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims that the program combines detoxification,… | Advanced Photonic Systems, LLC | Device | Class II | 3 |
| 21 Apr 2014 | Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68. | Pharmakon Pharmaceuticals | Drug | Class I | 4 |
| 11 Apr 2014 | YF brand CRACKER (SESAME), Net Wt. 14 oz. (400g), UPC 6 920580 733416 --- The product is packed in a plastic package. | Domega NY International Co Ltd | Food | Class I | 1 |
| 9 Apr 2014 | THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA. (68455) | Individual firm, name withheld | Drug | Class I | 1 |
| 28 Mar 2014 | AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City. | Nova Products, Inc. | Drug | Class I | 8 |
| 24 Mar 2014 | Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3 | Apotex Inc. | Drug | Class II | 9 |
| 18 Mar 2014 | Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test. | Nanosphere, Inc. | Device | Class III | 1 |
| 13 Mar 2014 | Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to… | Medtronic MiniMed Inc. | Device | Class II | 1 |
| 4 Mar 2014 | VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451. | Alkermes, Inc. | Drug | Class II | 1 |
| 4 Mar 2014 | Mut Dua Non YOUNG COCONUT CANDY, Net Weight: 10.6oz (300g), UPC 8 935054 702377 -- Product of Vietnam -- Packed for: HONG LEE TRADING INC. 225 JOHNSON AVE BROOKLYN, NEW YORK 11206 (718) 386-2100 --- NUTRITION FACTS: Serving Size 30oz. (85g), Servings per container 6 (67655) | Hong Lee Trading Inc | Food | Class I | 1 |
| 4 Mar 2014 | Golden Natural Mix Party Net Wt 23.00 oz. in a plastic round tub Product of Crown Food North Bergen, NJ 07047 UPC 098346021049 (68576) | Crown Food Distribution Inc | Food | Class I | 1 |
| 26 Feb 2014 | H-E-B Chipotle Con Queso; HOT; with Real Chipotle Peppers; NET WT; 16 OZ (1 LB) 454g; Made with Pride and Care for H-E-B, SAN ANTONIO, TEXAS 78204. Distributed in cases of 12/16 oz. jars. | Durrset Amigos, Ltd. | Food | Class II | 5 |
| 26 Feb 2014 | Price Chopper Orange Juice; 100% Pure ORANGE JUICE FROM CONCENTRATE; DISTRIBUTED BY THE PRICE CHOPPER, INC., SCHENECTADY, NY 12306; in one gallon plastic containers | Dean Foods, Inc. | Food | Class I | 4 |
| 25 Feb 2014 | DOS PADRES BRAND; SOUTHWEST QUESO; NET WT. 15.6 oz. (442g); Distributed by; Cyclone ENTERPRISES; Houston, Texas 77060 UPC: 64258 20110 | Consolidated Mills, Inc | Food | Class II | 3 |
| 25 Feb 2014 | SILVER STAR; TEX-MEX QUESO; CHIPOTLE QUESO; Medium Dip; NET WT. 16 OZ; (453g); Brought To You By: Silver Star Salsas; Box 50583; Austin, TX 78763 | Creative Foodworks, Inc | Food | Class II | 5 |
| 17 Feb 2014 | Cheese Pre-mix, CF 21-1, in 50 lbs bags, intended to be used in the manufacture of cheese dip | Custom Ingredients LLC | Food | Class II | 20 |
| 10 Feb 2014 | The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the… (68986) | Thermedx LLC | Device | Class II | 1 |
| 19 Dec 2013 | MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX | Individual firm, name withheld | Drug | Class I | 2 |
| 14 Nov 2013 | Grace Classic Coconut Milk Net 13.5 FL OZ (US) (400 mL) PRODUCT OF THAILAND Packed for: GraceKennedy Limited, 73 Harbour Street Kingston, Jamaica, W.I. (68680) | Grace Foods (USA) Inc | Food | Class III | 1 |
| 20 Sep 2013 | Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system… | Biomet Microfixation, LLC | Device | Class II | 1 |
| 18 Sep 2013 | El Tampiqueno Original Queso Fresco White Soft Cheese, Manufactured and distributed by El Tampiqueno Cheese Products, 1210 Summit St. Schulenberg, Texas 78956 (66327) | El Tampiqueno Food Products, LLC | Food | Class I | 1 |
| 13 Aug 2013 | Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 20 Jun 2013 | Oxyphen XR, 12 HR / CLINICAL STRENGTH FAT BURNER, 45 FAST ACTING EXTENDED RELEASE CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599747 | Beta Labs | Food | Class I | 4 |
| 14 Jun 2013 | Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is… | PIONEER SURGICAL TECHNOLOGY, INC. | Device | Class II | 1 |
| 17 Apr 2013 | NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502 (67904) | Unique Pharmaceutical, Ltd | Drug | Class II | 1 |
| 12 Mar 2013 | Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033 | Bio-Detek, Inc. | Device | Class II | 1 |
| 10 Sep 2012 | STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY | PIONEER SURGICAL TECHNOLOGY, INC. | Device | Class II | 1 |
| 31 Aug 2012 | The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 1 Sep 2011 | The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports,… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 7 Jul 2008 | Apple Cider Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed. | Jenis Splendid Ice Creams LLC | Food | Class II | 32 |