| 18 Mar 2014 | 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 11 Mar 2014 | Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01 | Paddock Laboratories, LLC | Drug | Class II | 1 |
| 7 Mar 2014 | Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or… (67702) | Clarity Medical Systems Inc | Device | Class II | 1 |
| 3 Mar 2014 | Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664. | Boston Scientific Corporation | Device | Class II | 1 |
| 3 Mar 2014 | Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery.… | Terumo Cardiovascular Systems Corporation | Device | Class II | 7 |
| 3 Mar 2014 | Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10 | McKesson Packaging Services | Drug | Class III | 1 |
| 3 Mar 2014 | Starbuck's brand Greek Yogurt Raspberry & Lemon Parfait; 6.1 oz single serve plastic cups, sold as individual unit. Finished product label is affixed to the top of the cup; nutritional labeling is located on the side of the cup, along with the printed code which appears on a white sticky label. UPC 6211198649. (67666) | Individual firm, name withheld | Food | Class I | 1 |
| 28 Feb 2014 | GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on… | GE Healthcare, LLC | Device | Class II | 1 |
| 28 Feb 2014 | Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and… | Teleflex Medical | Device | Class II | 1 |
| 28 Feb 2014 | Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to… | Philips Medical Systems North America Inc. | Device | Class II | 2 |
| 28 Feb 2014 | High Mowing Organic Sprouting Seeds Ancient Eastern Blend , 4 oz. resealable plastic bag UPC Code: 872724005445 (67721) | High Mowing Organic Seed | Food | Class II | 1 |
| 27 Feb 2014 | Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general… | Megadyne Medical Products, Inc. | Device | Class II | 1 |
| 26 Feb 2014 | Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur. | Biomet, Inc. | Device | Class II | 3 |
| 26 Feb 2014 | Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43 | Pfizer Us Pharmaceutical Group | Drug | Class III | 1 |
| 25 Feb 2014 | Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT | Zimmer, Inc. | Device | Class II | 15 |
| 24 Feb 2014 | REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought… | DePuy Orthopaedics, Inc. | Device | Class II | 6 |
| 21 Feb 2014 | MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS). | Medical Information Technology, Inc. | Device | Class II | 1 |
| 21 Feb 2014 | DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others | DeRoyal Industries Inc | Device | Class II | 1 |
| 20 Feb 2014 | PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the… | Biosense Webster, Inc. | Device | Class II | 1 |
| 19 Feb 2014 | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian… | Gyrus Medical, Inc | Device | Class II | 1 |
| 19 Feb 2014 | Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe. (67562) | Medefil Incorporated | Device | Class III | 1 |
| 19 Feb 2014 | FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed by Abbott Diabetes Care, Alameda, CA The… | Abbott Diabetes Care, Inc. | Device | Class I | 2 |
| 19 Feb 2014 | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) Tablets, 30 Tablet Bottles, Rx only. Manufactured for: Bristol-Myers Squibb & Gilead Sciences, LLC, Foster City, CA 94404. Made in Ireland. NDC 15584-0101-1. Manufactured for: Bristol-Myers-Squibb & Gilead Sciences, LLC, Foster… | Gilead Sciences, Inc. | Drug | Class III | 1 |
| 19 Feb 2014 | 4 oz. Heart - Shaped Box of Assorted Chocolates (67587) | Fannie May Confection Brands Inc | Food | Class I | 1 |
| 18 Feb 2014 | Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491 | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 18 Feb 2014 | Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 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… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 18 Feb 2014 | HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC 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 |
| 18 Feb 2014 | HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J 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 |
| 18 Feb 2014 | Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation. | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 18 Feb 2014 | Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. 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. | Remel Inc | Device | Class II | 1 |
| 18 Feb 2014 | M3536A HeartStart MRx with Wireless Link Upgrade (861289) 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 support, advanced… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 18 Feb 2014 | Newman's Own Salsa Con Queso, Medium All Natural Net Wt.16 oz., packaged in a glass jar UPC 0 20662 00353 9 (67565) | Newman'S Own Inc. | Food | Class II | 1 |
| 17 Feb 2014 | Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended… | WalkMed Infusion, LLC | Device | Class II | 1 |
| 17 Feb 2014 | XiO RPT 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 |
| 14 Feb 2014 | GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes,… | GE Healthcare, LLC | Device | Class II | 1 |
| 14 Feb 2014 | Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers. | Horiba Instruments, Inc dba Horiba Medical | Device | Class II | 1 |
| 14 Feb 2014 | Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 14 Feb 2014 | True Botanica brand Enzymes Plus, 45 CAPSULES, Product No. TB043-45, a Dietary Supplement --- Manufactured for True Botanica LLC, 1005 Richards Rd, Suite D, Hartland, WI 53029 | Nature's Value Inc. | Food | Class II | 1 |
| 14 Feb 2014 | Chocolate Ice Cream manufactured under the Dairy Rich brand and packaged in a 1.75 quart (1.66 L) (56 oz.) carton. (67530) | Individual firm, name withheld | Food | Class I | 1 |
| 14 Feb 2014 | Falafel King Green Chile Hummus, 10 oz, Plastic Tub, packaged in 12count and 8 count cases. Labeled in part ** Falafel King green chile hummus GF 100% NATURAL** | Falafel King Ent, Inc. | Food | Class I | 2 |
| 13 Feb 2014 | VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials.… | Accumetrics Inc | Device | Class II | 1 |
| 13 Feb 2014 | GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare… | GE Healthcare, LLC | Device | Class II | 1 |
| 13 Feb 2014 | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3. | Noven Pharmaceuticals, Inc. | Drug | Class II | 2 |
| 13 Feb 2014 | STONEWALL KITCHEN brand Chocolate Coconut Cupcake Mix, Net Wt. 22.5 oz. (637.9 g), UPC 7 11381 31535 4 -- DISTRIBUTED BY STONEWALL KITCHEN, STONEWALL LANE, YORK, ME 03909 | Raymond-Hadley Corp. | Food | Class II | 1 |
| 13 Feb 2014 | MORRISON'S BROWN GRAVY MIX, NET WT 13 OZ (369 g) mislabeled as MORRISON'S PANCAKE MIX, NET WT 5 LB (2.27 kg) (67507) | C. H. Guenther & Sons, Inc. | Food | Class II | 1 |
| 13 Feb 2014 | Bakes Sea Salt Potato Chips, Kettle Brand, Item 07-10982-000. It is packaged in a 4 oz. retail bag, 15 bags per case. Bag UPC 84114 10984 2. Case UPC 84114 10982 5. | Diamond Foods Inc | Food | Class I | 1 |
| 12 Feb 2014 | Jalapeno Ground 40, Elite Spice Code #JP9520, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794*** | Elite Spice Inc. | Food | Class I | 6 |
| 12 Feb 2014 | 18 lb box of Curly Parsley packaged in 3 wire wooden crates (67497) | Roth Farms Inc | Food | Class I | 1 |
| 11 Feb 2014 | Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home,… (67550) | Phillips Respironics, Inc. | Device | Class I | 1 |
| 11 Feb 2014 | 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09 | Hospira Inc. | Drug | Class II | 1 |
| 10 Feb 2014 | bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO. | Biomerieux Inc | Device | Class II | 1 |
| 10 Feb 2014 | BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement. (67475) | Heraeus Kulzer, LLC. | Device | Class II | 1 |
| 10 Feb 2014 | Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50 | Actavis Elizabeth LLC | Drug | Class II | 1 |
| 10 Feb 2014 | Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02 | Hospira Inc. | Drug | Class II | 1 |
| 10 Feb 2014 | Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75 (67688) | Pinnacle Biologics Inc | Drug | Class III | 1 |
| 10 Feb 2014 | Item number T3695, White cheddar jalapeno seasoning powder, 50 lb bags. (67469) | All American Seasonings | Food | Class I | 1 |
| 10 Feb 2014 | FLOUR TORTILLAS: FAJITA 6" 15 0Z UPC Code 1569602222, HOMESTYLE 8" 24 OZ UPC Code 1569602221, BURRITO 10" 28OZ UPC Code 1569602223, GRANDE 12" 36 OZ UPC Code 1569602224, JUAREZ 8" 24 OZ UPC Code 1569603337, 8" RESTAURANT 23 OZ UPC Code 1569602230, 10" RESTAURANT 28 OZ UPC Code 1569602226. Packaged in clear poly… | Tortillas Mexico Mexico, Incorporated | Food | Class II | 3 |
| 8 Feb 2014 | Heart of the Valley brand Parsnips, produce of U.S.A., packaged in the following sizes: 16 ounces (453 grams), UPC 31446-22016; 20 ounces (566 grams), UPC 31446-22020; 20 lb. bags; and 40 lb boxes (67479) | Ed Fields & Sons, Inc | Food | Class III | 1 |
| 7 Feb 2014 | HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope¿¿ System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display,… (67418) | Leica Biosystems Imaging, Inc. | Device | Class II | 1 |
| 7 Feb 2014 | GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is… | GE Healthcare, LLC | Device | Class II | 3 |
| 7 Feb 2014 | FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip. (67468) | Djo Surgical | Device | Class II | 1 |
| 7 Feb 2014 | Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the… | Convatec Inc. | Device | Class II | 6 |
| 7 Feb 2014 | Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77. | Actavis | Drug | Class III | 1 |
| 7 Feb 2014 | Whole (round) Tomatoes packed in cardboard boxes of 20 and 25 lbs each. (67460) | BIG RED TOMATO PACKERS, LLC | Food | Class I | 1 |
| 7 Feb 2014 | Natural Grocers brand Dark Chocolate Almonds; six-ounce bags bearing UPC code 0-0008265007-0 | Natural Grocers by Vitamin Cottage | Food | Class I | 1 |
| 6 Feb 2014 | Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is… | Philips Medical Systems North America Inc. | Device | Class II | 1 |
| 6 Feb 2014 | Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a… | Lin-Zhi International Inc | Device | Class II | 2 |
| 6 Feb 2014 | Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging… (67490) | Individual firm, name withheld | Device | Class III | 1 |
| 6 Feb 2014 | Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized… | Philips Medical Systems North America Inc. | Device | Class II | 1 |
| 6 Feb 2014 | Classic Sysco Custom Ready to Use Cherry Pie Filling; with other Natural Flavors #10 can - Net wt 7 lbs (3.18kg) UPC 1 00 74865 38257 8 Manufactured for Sysco by Lyons Magnus, Fresno, CA | Individual firm, name withheld | Food | Class II | 2 |
| 6 Feb 2014 | Multifoods Bakery Products, Cranberry Orange Muffins, 5.4oz (frozen muffin batter in muffing liner, inside plastic tray, overwrapped with plastic, packaged in corrugate case), 25.3lbs case is unit for sale. UPC 10035074485443. Manufactured by: CSM Bakery NA, Inc, Tucker, GA. | CSM Bakery Products NA | Food | Class II | 2 |
| 6 Feb 2014 | Uncle Ben's (R), Infused(R) Rice Mexican Flavor, net weight 5 LB (2.27 kg) and 25 LB (11.34 kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA | Mars Food US | Food | Class II | 7 |
| 6 Feb 2014 | "***Brazo gitano (rolled cake)***pineapple paste filling***" | E. Franco & Co. Inc | Food | Class II | 17 |
| 5 Feb 2014 | Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the qualitative… | Alere San Diego, Inc. | Device | Class II | 1 |
| 5 Feb 2014 | Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of… | Synthes, Inc. | Device | Class II | 1 |
| 5 Feb 2014 | Dark Meat Fajita School Lunch #3 (67478) | Pepper Source Limited | Food | Class I | 1 |
| 4 Feb 2014 | Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650. | Focus Diagnostics Inc | Device | Class II | 1 |
| 4 Feb 2014 | Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 4 Feb 2014 | Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 9 |
| 4 Feb 2014 | Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2. | Actavis Elizabeth LLC | Drug | Class II | 1 |
| 4 Feb 2014 | Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3. | Aaron Industries Inc | Drug | Class III | 1 |
| 4 Feb 2014 | Candy coated popcorn shaped into a heart weighing 1.5 ounces per piece and individually wrapped in clear plastic packaging. There are 24 popcorn balls per case. (67467) | Popcorn Factory, The | Food | Class II | 1 |
| 3 Feb 2014 | Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients… | Carl Zeiss Meditec AG | Device | Class II | 1 |
| 31 Jan 2014 | MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 31 Jan 2014 | Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384, T15311, T15752, T15822, T15949, T16117,… | Greatbatch Medical | Device | Class I | 1 |
| 31 Jan 2014 | Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755,… (67576) | Bock,Otto,Orthopedic Ind,Inc | Device | Class II | 1 |
| 31 Jan 2014 | HUDSON VALLEY HOMESTEAD BUSHWHACKER'S SAVORY SAUCE, Mild, Net Wt. 14 oz., UPC: 7 51122 00091 0, Hudson Valley Homstead 102 Sheldon Lane Craryville, New York 12521 (518) 851-7336, www.hudsonvalleyhomstead.com | Charlemagnes Tree Farm Ltd | Food | Class II | 2 |
| 31 Jan 2014 | Bar Star Snack Mix, 1 lb plastic bag and 25 lb plastic bags in a cardboard box. Box labeled DAYTON'S ESTABLISHED 1923 DAYTON NUT SPECIALTIES, INC. 919 N. MAIN DAYTON, OHIO 45405 with a white stick on label which reads, "25# BAR STAR MIX | Creation Gardens | Food | Class II | 2 |
| 31 Jan 2014 | Creation Special Snack Mix; 25 lb. cardboard carton | Dayton Nut Specialties Inc | Food | Class II | 2 |
| 30 Jan 2014 | PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure… | KCI USA, INC. | Device | Class II | 8 |
| 30 Jan 2014 | Ginger Snap Cookies, 12 oz., Item Code: 48918, UPC 0-41380-23359 | Unified Grocers Inc. | Food | Class I | 1 |
| 29 Jan 2014 | Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8. | Fougera Pharmaceuticals Inc. | Drug | Class III | 1 |
| 28 Jan 2014 | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients. | AMO Puerto Rico Manufacturing, Inc. | Device | Class II | 1 |
| 28 Jan 2014 | Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation. (67435) | AlterG, Incorporated | Device | Class II | 1 |
| 28 Jan 2014 | Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02 | Caraco Pharmaceutical Laboratories, Ltd. | Drug | Class II | 1 |
| 28 Jan 2014 | Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20 | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class III | 1 |
| 28 Jan 2014 | Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230… (67432) | RX South LLC DBA RX3 Pharmacy | Drug | Class II | 1 |
| 27 Jan 2014 | Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely… | Synthes, Inc. | Device | Class II | 1 |
| 27 Jan 2014 | CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery… | Cardiovascular Systems, Inc. | Device | Class III | 1 |
| 27 Jan 2014 | syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 27 Jan 2014 | MARY ANN'S Chocolates Signature Assortment,May Contain Sugar, Chocolate, Butter, Corn Syrup, Assorted Fruit and Nuts, Coconut, Vegetable Oil, Egg or Vegetable Albumen , Salt, Natural and Artificial Flavors and Certified Food Colors. Fruits Contain Sulfur Dioxide, Savory Foods, Inc. Grand Rapids, MI 49507 SIGNATURE… (67403) | Savory Foods, Inc. | Food | Class II | 1 |
| 24 Jan 2014 | RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging. (67470) | Clarity Medical Systems Inc | Device | Class II | 1 |
| 24 Jan 2014 | NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis. | NxStage Medical, Inc. | Device | Class II | 1 |
| 24 Jan 2014 | NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia… | Hologic, Inc | Device | Class II | 1 |
| 24 Jan 2014 | Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar… | Remel Inc | Device | Class II | 1 |
| 24 Jan 2014 | Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major… | Carestream Health Inc. | Device | Class II | 2 |
| 24 Jan 2014 | Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 24 Jan 2014 | Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02. | Teva Pharmaceuticals USA | Drug | Class II | 4 |
| 23 Jan 2014 | Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial… | Atricure Inc | Device | Class II | 1 |
| 23 Jan 2014 | Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture,… | Smith & Nephew Inc | Device | Class II | 1 |
| 22 Jan 2014 | Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose… | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 21 Jan 2014 | Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of… | Dako North America Inc. | Device | Class II | 1 |
| 21 Jan 2014 | Buzzaround XL scooters' Product Usage: mobility (67416) | Golden Technologies, Inc. | Device | Class II | 1 |
| 21 Jan 2014 | Cactus Leaves (Nopales), 44 lbs. (67345) | Tijuana'S Produce Co. | Food | Class III | 1 |
| 20 Jan 2014 | ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of… | Horiba Instruments, Inc dba Horiba Medical | Device | Class II | 1 |
| 20 Jan 2014 | GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine radiography exams,… | GE Healthcare, LLC | Device | Class II | 1 |
| 20 Jan 2014 | Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 07206 (67431) | Deb-El Food Products, LLC. | Food | Class I | 1 |
| 17 Jan 2014 | MEDITECH Microbiology - Calculator/data processing module, for clinical use. | Medical Information Technology, Inc. | Device | Class II | 1 |
| 17 Jan 2014 | Cactus Leaves/Pads (Nopales) MexpoGroup Brand MexpoGroup Fresh Produce Colonia Buenos Aires Norte, Tijuana, Baja California, Mexico. (67356) | RCI Produce | Food | Class II | 1 |
| 16 Jan 2014 | DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries. | DeRoyal Industries Inc | Device | Class II | 1 |
| 16 Jan 2014 | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 | Ranbaxy Inc. | Drug | Class II | 1 |
| 15 Jan 2014 | VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic… | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 15 Jan 2014 | Rise n Roll Bakery & Deli, White Powdered Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties: White Powdered Donut : Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry… | Rise'n Roll Bakery, LLC | Food | Class I | 10 |
| 14 Jan 2014 | The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and… (67342) | Instrumentarium Dental, PaloDEx Group Oy | Device | Class II | 1 |
| 14 Jan 2014 | Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001 (67661) | Traxx International Corp | Drug | Class II | 1 |
| 13 Jan 2014 | Kinnikinnick Original Homestyle Waffles-Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box-UPC: 62013300198 1 | UNFI | Food | Class I | 5 |
| 13 Jan 2014 | Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz Cardboard Box UPC 62013310512 2 | Bozzutos' Inc. | Food | Class I | 2 |
| 11 Jan 2014 | Markets of Meijer Pretzel Hamburger Bun, 4 count, NT.WT. 12.0 oz (0.75 lb), 16 oz ( 1 lb) UPC 412500558-2; Ingredients: Enriched Wheat Flour( Wheat Flour, malted barley flour, niacin.....)water, sugar, canola oil, salt, .. , dough conditioner, whey powder, yeast, dough conditioner... soy oil, wheat gluten Allergens:… | Meijer Distribution, Inc | Food | Class I | 2 |
| 10 Jan 2014 | 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device that is indicated… | Zimmer, Inc. | Device | Class II | 1 |
| 10 Jan 2014 | Chocolate Pecan Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" | Individual firm, name withheld | Food | Class I | 18 |
| 10 Jan 2014 | Newmans Own¿ Organics Newmans Special Blend 80 Count K-Cup¿ Packs; UPC 09955515593; Product Code: 15593 281792 | Green Mountain Coffee Roasters | Food | Class II | 1 |
| 9 Jan 2014 | Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) | Smith & Nephew Inc. | Device | Class II | 6 |
| 9 Jan 2014 | VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 9 Jan 2014 | Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use… | Mako Surgical Corporation | Device | Class II | 1 |
| 8 Jan 2014 | CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote… | Veridex, LLC | Device | Class II | 1 |
| 8 Jan 2014 | Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor. | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 6 Jan 2014 | cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing… | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 6 Jan 2014 | Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 6 Jan 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway. | Teleflex Medical | Device | Class I | 14 |
| 6 Jan 2014 | Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal… | Exactech, Inc. | Device | Class II | 1 |
| 3 Jan 2014 | a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe… (67303) | Individual firm, name withheld | Drug | Class II | 1 |
| 3 Jan 2014 | Sampler Bag Biscotti consists of 3 pieces of Almond dipped in Dark Chocolate; 3 pieces of Cranberry dipped in White Chocolate; and 3 pieces of Cranberry & Toasted Almonds. Sampler Bag is packaged in white windowed paper coated bakery bags and sold under Tonia's Biscotti brand. | Yukon Concessions Alaska LLC | Food | Class I | 11 |
| 31 Dec 2013 | Roasting Cinnamon Butternut Squash Net Wt. 2 lbs (907 g) Foam Tray with 3 per case. Keep Refrigerated Distributed by Renaissance Food Group LLC UPC 825786790333 (67482) | F & S Produce Co., Inc. | Food | Class II | 1 |
| 31 Dec 2013 | The Cultured Kitchen Herb Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504922714 Produced by: The Cultured Kitchen LLC… | The Cultured Kitchen | Food | Class I | 6 |
| 20 Dec 2013 | Marlyce's Homemade Style Noodles, Net Wt. 8 oz, Packaged in plastic bags, 10 per case, UPC 094219217069. Manufactured by L.M.Noodle Company, LLC, 416 Main Street, Wiggins, CO 80654. (67579) | L. M. Noodle Company, LLC | Food | Class II | 1 |
| 19 Dec 2013 | VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilization cycles. | Steris Corporation | Device | Class II | 1 |
| 19 Dec 2013 | Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 19 Dec 2013 | Good Neighbors Specialty Foods Tabouli Salad; 8 oz plastic container; UPC 18561500007 and 14 oz plastic container; 18561500068 (67151) | Good Neighbors Specialty Foods, LLC | Food | Class II | 1 |
| 18 Dec 2013 | Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These… (67388) | Individual firm, name withheld | Device | Class II | 1 |
| 18 Dec 2013 | Benefiber fiber supplement stick packs, sugar free and taste free, packaged in the following configurations: (1) Benefiber Fiber Supplement, On-The-Go Stick Packs, Sugar Free, Clear & Taste-Free, packaged in 8.16-oz. boxes containing 68/0.12-oz. stick packs, UPC 300670176686. Distributed by Novartis Consumer Health,… | Novartis Consumer Health | Food | Class II | 1 |
| 17 Dec 2013 | Valued Naturals Natural Coconut Net wt. 8oz (216.80g) Imported by Philippines International Foodsource LLC 52 Richboynton Rd, Dover, NJ 07801 Packaged in 8 oz bag 12 per case. | International Foodsource, LLC | Food | Class III | 1 |
| 16 Dec 2013 | Siemens Artis zee Ceiling Systems. Angiographic x-ray system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 12 Dec 2013 | VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing… | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 11 Dec 2013 | GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is indicated for use in generating… | GE Healthcare, LLC | Device | Class II | 1 |
| 11 Dec 2013 | TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 9 Dec 2013 | PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility. | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 7 Dec 2013 | Nicomex Camaron Entero Whole Shrimp Net Wt 1 oz (28.35 grams). Productos Mexicanos Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 Tel. (973) 815-2062. UPC 8 84678 10173 9. | Nicomex Inc. | Food | Class II | 2 |
| 25 Nov 2013 | RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner. | Elekta, Inc. | Device | Class II | 1 |
| 25 Nov 2013 | Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators. | Elekta, Inc. | Device | Class II | 3 |
| 25 Nov 2013 | Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. | Elekta, Inc. | Device | Class II | 1 |
| 22 Nov 2013 | 4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and Point-Lok¿ needle safety device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via… | Smiths Medical ASD, Inc. | Device | Class II | 13 |
| 21 Nov 2013 | 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38. | Baxter Healthcare Corp. | Drug | Class I | 2 |
| 20 Nov 2013 | 10" Chocolate Supreme Cake Layers, NET WT. 20 oz. packed in cases of 12. Keep Frozen until ready to use. CSM Bakery Products NA, Inc., Tucker, GA 30084 USA Product is for institutional use. (66928) | CSM Bakery Products North America | Food | Class II | 1 |
| 18 Nov 2013 | Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04. | Baxter Healthcare Corp. | Drug | Class I | 3 |
| 15 Nov 2013 | Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency | Shimadzu Medical Systems | Device | Class II | 1 |
| 14 Nov 2013 | Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System | Smith & Nephew Inc. | Device | Class II | 2 |
| 6 Nov 2013 | Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton) | Actavis Elizabeth LLC | Drug | Class II | 1 |
| 1 Nov 2013 | Lidocaine 4% Urethral Gel | Natures Pharmacy & Compounding Center | Drug | Class II | 48 |
| 29 Oct 2013 | Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc disease, B.… | Orthofix, Inc | Device | Class II | 1 |
| 25 Oct 2013 | *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 2) List Number… | Hospira Inc. | Device | Class II | 1 |
| 22 Oct 2013 | Colon Rebuild I (90 capsules), 2boxes x 240 bottles, 1box x 200 bottles. | Global Vitality, Inc. dba Enzyme Process International | Food | Class II | 9 |
| 19 Oct 2013 | Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 (67214) | Specialty Medicine Compounding Pharmacy, P.C. | Drug | Class I | 1 |
| 18 Oct 2013 | Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30. | Hospira Inc. | Drug | Class I | 1 |
| 17 Oct 2013 | Trabecular Metal" Reverse Shoulder System | Zimmer, Inc. | Device | Class II | 1 |
| 17 Oct 2013 | VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. | Ortho-Clinical Diagnostics | Device | Class II | 2 |
| 3 Oct 2013 | ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery. | Biomet 3i, LLC | Device | Class III | 1 |
| 3 Oct 2013 | Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the vital signs of patients undergoing MRI… | Invivo Corporation | Device | Class II | 1 |
| 1 Oct 2013 | GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of… | GE Healthcare, LLC | Device | Class I | 3 |
| 1 Oct 2013 | TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated… | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 6 Sep 2013 | PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are… | Winco Mfg., LLC | Device | Class II | 4 |
| 26 Aug 2013 | Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.***… | Biomet 3i, LLC | Device | Class II | 1 |
| 14 Aug 2013 | ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures. | Medline Industries, Inc. | Device | Class I | 11 |
| 1 Aug 2013 | BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095. (65900) | CTV Best Group | Drug | Class I | 1 |
| 25 Jul 2013 | Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray… | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 22 Jul 2013 | Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. | Biomet 3i, LLC | Device | Class II | 5 |
| 22 Jul 2013 | B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 | Mira Health Products Ltd. | Drug | Class I | 3 |
| 15 Jul 2013 | Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments. (67520) | China Daheng Group Inc. | Device | Class II | 1 |
| 5 Jul 2013 | pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes. | Radiometer America Inc | Device | Class II | 1 |
| 27 Jun 2013 | Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) | Fabscout Entertainment, Inc | Drug | Class I | 2 |
| 27 Jun 2013 | GOKNUR Organic Frozen/IQF Pomegranate Arils. Packed in 10 kg cases. Labeling is bilingual and in English, reads in part:"goknur***Product of Turkey***ORGANIC FROZEN/IQF POMEGRANATE ARILS***Production Date 17.10.2012***Lot No 12-15-13-2-1-O***Net Weight (kg) 10***Crop Year 2012***Expiry Date 17.10.2014***Carton No… (65580) | Purely Pomegranate, Inc | Food | Class I | 1 |
| 26 Jun 2013 | Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment.. (67517) | Individual firm, name withheld | Device | Class II | 1 |
| 28 May 2013 | All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes | Elekta, Inc. | Device | Class II | 1 |
| 28 May 2013 | SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases. | Elekta, Inc. | Device | Class II | 1 |
| 1 May 2013 | DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible. | Elekta, Inc. | Device | Class II | 1 |
| 15 Mar 2013 | McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision… | MCKESSON TECHNOLOGIES INC. | Device | Class I | 1 |
| 18 Feb 2013 | Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation. (67421) | Individual firm, name withheld | Device | Class II | 1 |
| 15 Oct 2012 | The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24.… (67250) | Ossur Americas, Inc. | Device | Class II | 1 |
| 27 Jun 2012 | Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106. (67516) | Individual firm, name withheld | Device | Class II | 1 |
| 25 Mar 2011 | GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4).… | GE Healthcare, LLC | Device | Class II | 1 |