| 6 Dec 2013 | FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11 | Fresenius Kabi USA, LLC | Drug | Class III | 1 |
| 3 Dec 2013 | ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations and label printing. The primary use of… | Baxter Corporation Englewood | Device | Class II | 1 |
| 2 Dec 2013 | Trader Joe's Butternut Squash & Creamed Spinach Gratin, 16 oz. (66984) | Huxtable's Kitchen Inc | Food | Class I | 1 |
| 26 Nov 2013 | outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and… | Biomet, Inc. | Device | Class II | 1 |
| 26 Nov 2013 | InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA), | GE OEC Medical Systems, Inc | Device | Class II | 1 |
| 25 Nov 2013 | MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure reagent kits, automated filling of… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 23 Nov 2013 | Trader Joe's Authentically Korean Seaweed Salad with Spicy Dressing, Net Wt. 3.5oz (99g), SKU 97677. (66920) | Jayone Foods, Inc. | Food | Class I | 1 |
| 22 Nov 2013 | Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood… | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 22 Nov 2013 | Source Naturals Essential Enzyme Ultra VEGI-CAP: Premium Digestive Enzyme Blend; 30, 60, 90 & 120 count bottles. Vegetarian capsules Manufactured for: Source Naturals, Inc. Santa Cruz, CA | Threshold Enterprises Ltd | Food | Class II | 1 |
| 22 Nov 2013 | Senor Murphy Santa Fe Candymaker Pecan Bueno, 4oz and 1 lb. Handmade with pecans, sugar, corn syrup, butter, soda, and salt. | Senor Murphy Candymaker, LLC | Food | Class II | 8 |
| 21 Nov 2013 | 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown… | 3M Company - Health Care Business | Device | Class II | 1 |
| 20 Nov 2013 | Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses | CooperVision Inc. | Device | Class II | 2 |
| 19 Nov 2013 | Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment. | Ultradent Products, Inc. | Device | Class III | 1 |
| 19 Nov 2013 | NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion… | Zimmer, Inc. | Device | Class II | 5 |
| 19 Nov 2013 | PCC, Rebecca's Natural Food, Sprouts Famous Market, Ritzman Pharmacy, Earth Fare, Hartig Drug, Viroqua Food, Ramona Fitness Center, Independent Choice (Health Trail Natural Foods-The Crunchy Grocer), Jimbo's, Outpost Natural Foods BRANDS- Woman's Once Daily Tablets - A dietary Supplement,Product Code… (66898) | Nexgen Pharma, Inc. | Food | Class II | 1 |
| 18 Nov 2013 | CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting… | Individual firm, name withheld | Device | Class II | 3 |
| 18 Nov 2013 | SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. | DePuy Orthopaedics, Inc. | Device | Class II | 12 |
| 18 Nov 2013 | FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the… | Abbott Diabetes Care, Inc. | Device | Class I | 2 |
| 18 Nov 2013 | Flora Double Ginger Herbal Tea Blend, 16/1.24 oz (35.2g) tea bags per package. UPC 0 61998 63757 9 The product is labeled in parts: "***DOUBLE GINGER HERBAL TEA BLEND***FLORA***CERTIFIED ORGANIC***FRESH-SEALED TEA BAGS***16***NET WT 1.24 oz***(35.2 g)***INGREDIENTS: GINGER ROOT, LEMONGRASS HERB, PEPPERMINT LEAVES,… (66959) | Flora Inc | Food | Class II | 1 |
| 17 Nov 2013 | Aunt Jemima(R) HOMESTYLE FRENCH TOAST, 6 COUNT, NET WT. 12.5 OZ (354 g), UPC Code: 019600057703 | Pinnacle Foods, LLC | Food | Class II | 1 |
| 15 Nov 2013 | Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt… | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 15 Nov 2013 | HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 | Instrumentation Laboratory Co. | Device | Class II | 3 |
| 14 Nov 2013 | VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test… | Accumetrics Inc | Device | Class II | 1 |
| 14 Nov 2013 | Digestive Enzymes, Digestion, 4Life, Dietary Supplement, 90 Capsules, A Product of 4Life Manufactured by BioMedical Research Laboratories, LLC, Sandy, UT, Item #23017. (66863) | 4Life Research, LLC | Food | Class II | 1 |
| 14 Nov 2013 | Crunch Pak Apple Slices with Low Fat Caramel Dip, 5/2.5 oz. Tart with Caramel Sauce. The clamshell includes 5/2 oz. bags of sliced apples and 5/ 0.5 oz. packages of caramel (sauce) dip. The UPC on the clamshell is 7 32313 09113 9. The clamshell package is labeled in parts: "***CRUNCH PAK***TART***apple Slices***WITH… | Crunch Pak, LLC | Food | Class I | 4 |
| 13 Nov 2013 | Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. " Transoral intubation " Transnasal intubation " Evaluation of placement of endotracheal and double lumen endotracheal tubes " Provide visual access to the larynx and… | Karl Storz Endoscopy America Inc | Device | Class II | 2 |
| 13 Nov 2013 | Gluten Free 60 vcaps, sku#609492310194. 12 units per shipping carton/case. (66860) | Mrm | Food | Class II | 1 |
| 13 Nov 2013 | Chocolate La Boulange Soft Caramel, Net WT. 8.4 oz. (238 g); Cooked in small batches in copper pots; all natural La Boulange South San Francisco, CA (66876) | The New French Bakery | Food | Class I | 1 |
| 12 Nov 2013 | Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total… | Zimmer, Inc. | Device | Class II | 3 |
| 12 Nov 2013 | 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. NDC: 0338-0644-06. | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 11 Nov 2013 | STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products | Device | Class II | 2 |
| 11 Nov 2013 | Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting. | Sunrise Medical (US) LLC | Device | Class II | 1 |
| 11 Nov 2013 | Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 11 Nov 2013 | Allergy Research Group Sugar Balance Formula, dietary Supplement, Hypoallergenic, 90 vegetarian capsules. Formulated exclusively for: Allergy Research Group; Alameda, CA 94502. (66829) | Allergy Research Group | Food | Class II | 1 |
| 11 Nov 2013 | Dawn's Vidalia Onion Dip, Net Wt. 5 lbs. (2.27 kg) | Dawn's Foods, Inc. | Food | Class I | 1 |
| 8 Nov 2013 | VersaSafe Extension Set, Model No. 21000M-007 | CareFusion 303, Inc. | Device | Class II | 1 |
| 8 Nov 2013 | SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. | CareFusion 303, Inc. | Device | Class II | 1 |
| 8 Nov 2013 | FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate… | Qualigen Inc | Device | Class II | 4 |
| 8 Nov 2013 | Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750 Hematology Analyzer provides automated… | Beckman Coulter Inc. | Device | Class II | 2 |
| 8 Nov 2013 | PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India | Fresenius Kabi USA, LLC | Drug | Class III | 1 |
| 8 Nov 2013 | TriEnza bulk powder distributed in a 5 kilogram polyethylene bag. (66824) | Houston Nutraceuticals, Inc | Food | Class II | 1 |
| 8 Nov 2013 | Nutritional Frontiers Cyb Zyme- A Dietary Supplement for Complete Digestive Support 90 count | FoodScience Corporation | Food | Class II | 4 |
| 8 Nov 2013 | Plum Organics Broccoli & Apple Organic Baby Food, 4 oz. pouch; Flexible pouch with Re-sealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM… | Plum Inc | Food | Class II | 30 |
| 8 Nov 2013 | HyVee Chocolate Caramel Clusters, packaged in 9-oz. clear plastic clamshell containers (UPC 077232125153), 16 containers/case (UPC 10077232125150). The firm name on the label is HyVee, West Des Moines, IA. | Palmer Candy Co | Food | Class I | 2 |
| 7 Nov 2013 | Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10. | West-Ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 7 Nov 2013 | (a) ONEBODE Flo daily, probiotic enzyme digestive, 90 capsules, dietary supplement, Product No. T00135, UPC 0 14834 00135 5; (b) ONEBODE Flo for Family, probiotic enzyme digestive, 360 capsules, dietary supplement, Product No. T00109, UPC 0 14834 00109 6; (c) ONEBODE Flo daily, probiotic enzyme digestive, 6 capsules,… (66766) | Global Health Laboratories, LLC | Food | Class II | 1 |
| 7 Nov 2013 | Ortho Molecular Products DigestzymeV. Dietary Supplement. Gastrointestinal health. 90 (product code 128090 and 128090U) and 180 capsules (product code 128180 and 128180U). | Ortho Molecular Products Inc | Food | Class II | 1 |
| 7 Nov 2013 | Chocolate Cream Pie, 4.5 oz. package, 12 pks/case. UPC # 891796002732 (66932) | 3 Fellers | Food | Class I | 1 |
| 7 Nov 2013 | UT-Fem¿ FOR WOMEN, urinary tract SOLUTION, Dietary Supplement, 42 Vegetable Capsules, Product No. 110403, UPC 7 98304 24865 4 -- Manufactured for: Global Quality Health Inc. (66765) | Global Health Laboratories, LLC | Food | Class II | 1 |
| 7 Nov 2013 | Garden-Fresh,,1/4" x 1" Green Pepper Sticks, 2/2 lb., 0 11596 40586 5 11/9/2013-11/11/2013; Garden-Fresh, Green Pepper Sticks 3/16" , 1/15 lb. , 0 11596 55835 6 11/5/2013 Garden-Fresh, Green Peppers Diced 3/8", 1/5 lb., 0 11596 50549 7 , 10/31/2013 - 11/5/2013 | Garden-Fresh Foods, Inc. | Food | Class I | 255 |
| 6 Nov 2013 | Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue. | Karl Storz Endoscopy America Inc | Device | Class II | 1 |
| 6 Nov 2013 | Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05 | Sandoz Inc | Drug | Class III | 1 |
| 6 Nov 2013 | Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs steel cylinders, Distributed by AIRGAS USA, LLC Radnor, PA (66929) | Airgas Medical Services | Drug | Class II | 1 |
| 5 Nov 2013 | SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to… (66983) | ASI Medical, Inc. | Device | Class II | 1 |
| 5 Nov 2013 | Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract. | Boston Scientific Corporation | Device | Class II | 3 |
| 4 Nov 2013 | LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with… (66836) | Lanx, Inc. | Device | Class II | 1 |
| 4 Nov 2013 | Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery… | Individual firm, name withheld | Device | Class II | 19 |
| 4 Nov 2013 | Grove Grow Notes Fruit of Wolfberry (Fructus Lycii) Net Wt: 12 oz (340g) S & M (USA) Enterprise 4703 2nd Avenue Brooklyn, NY 11232 UPC 4580158101515 S & M (HK) Enterprise Ltd Rm, 3.8/F., Yue Xiu Bldg., 160-174Lockhart Road, Wan Chai, HK Product of China | S & M International Inc | Food | Class I | 1 |
| 1 Nov 2013 | Bremer Garlic Shrimp MEAL IN MINUTES Pasta in Garlic Sauce with Broccoli, Shrimp, Corn and Carrots 21 oz bags, CONTAINS: WHEAT, MILK, CRUSTACEAN SHELLFISH (SHRIMP) Distributed by ALDI Inc., Batavia, IL 60510 0 41498-17223-7 3-cheese chicken & Chicken Lo Mein was recalled by USDA. (66756) | Gourmet Express LLC | Food | Class I | 1 |
| 1 Nov 2013 | Mixed Seed Brittle ("Pepitoria Mixed"), in cellophane packages, Net Wt. 2oz (57g), UPC 6 61444 00017 1. | Individual firm, name withheld | Food | Class II | 5 |
| 31 Oct 2013 | NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic… | Zimmer, Inc. | Device | Class II | 1 |
| 30 Oct 2013 | Easy Diagnost Eleva Universal Fluoroscopic applications | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 30 Oct 2013 | Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for… | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 30 Oct 2013 | Houston Enzymes TriEnza with DPP IV Activity, Broad-Spectrum Enzyme Product for general Digestive Support, packaged in 90-(SKU 53379) and 180-(SKU 53380) capsule bottles. The firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam Springs, AR (2) 9212 TRIENZA Bulk Capsules (SKU 91980) packaged in varying… | National Enzyme Co | Food | Class II | 81 |
| 30 Oct 2013 | Garden-Fresh Chipotle Ranch Potato Salad, Product Code 0 11596 51002 6, 5 lb. | Garden-Fresh Foods, Inc. | Food | Class I | 213 |
| 30 Oct 2013 | LIPARI OLDTYME Mexicali Dip, Keep Refrigerated, outer box Net Wt. 1 0 lbs. Distributed by Lipari Foods, Warren, Ml 48089 Inner container: Mexicali Dip, Dutch Treat Salads, Zeeland MI Net Wt. 5 Lbs. Mexicali Dip, Dutch Treat Salads, Zeeland , MI Net Wt 14 oz. 396.9 g Ingredients: INGREDIENTS CULTURED SOUR CREAM… (66719) | DUTCH TREAT SALADS, INC | Food | Class I | 1 |
| 29 Oct 2013 | MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical… (66739) | Individual firm, name withheld | Device | Class III | 1 |
| 29 Oct 2013 | Tres Leches, Lymar, Peso Neto 3 oz, Ponce, Puerto Rico (66676) | Individual firm, name withheld | Food | Class I | 1 |
| 29 Oct 2013 | DRUK Orange Squash Contains 25% Orange Juice Net Wt. 24 fl oz. Imported by: Balajee Trade Link, LLC Scranton, PA USA Product of Bhutan | Balajee Trade Link LLC | Food | Class II | 2 |
| 29 Oct 2013 | Caramel Sea Salt Chocolate Chip Cookie, 3-oz (85g), individually wrapped in plastic wrapper and labeled in part: Manufactured for Simply D'lish, LLC.; Aurora, IL 60504; www.simplydlish.biz | Simply D'Lish, LLC | Food | Class II | 5 |
| 28 Oct 2013 | Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of… | Integra LifeSciences Corp. d.b.a. Integra Pain Management | Device | Class II | 1 |
| 28 Oct 2013 | Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking. (66735) | Nephros Inc | Device | Class I | 1 |
| 28 Oct 2013 | Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the… | Abbott Point Of Care Inc. | Device | Class II | 1 |
| 28 Oct 2013 | Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking.… | Nephros Inc | Device | Class I | 2 |
| 28 Oct 2013 | Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions. LATEX FREE , CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Single Use Only bands items together and podiatry office uses bands as… | Centurion Medical Products Corporation | Device | Class II | 1 |
| 28 Oct 2013 | SIG CAFE ITALIAN PASTA SALAD KIT, 216325, NET WT 5.68 LBS, Distributed by Lucerne Foods, Inc., PO Box 99, Pleasanton, CA 94566-0009, 877-232-4271 (66704) | Taylor Farms Illinois Inc | Food | Class II | 1 |
| 25 Oct 2013 | ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 25 Oct 2013 | REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament. | Biomet, Inc. | Device | Class II | 1 |
| 25 Oct 2013 | 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 25 Oct 2013 | Mozzarella String Cheese made with 2% milk for 1/4 less fat, sold under Kraft brand or Polly-O brand and packaged with either 12 or 24 pieces of mozzarella cheese individually wrapped in plastic and sold in a plastic bag with a net weight respectively of 10 oz. (283g) or 20 oz. (1 lb. 4 oz.) 566g. | Kraft Foods Group | Food | Class II | 8 |
| 25 Oct 2013 | Broccoli Crunch Kit 1 cnt, 432714, 59520, TAYLOR FARMS TN, SMYRNA, TN 37167 | Taylor Farms Tennessee, Inc. | Food | Class II | 6 |
| 24 Oct 2013 | Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs | Kimberly-Clark Corporation | Device | Class II | 1 |
| 24 Oct 2013 | C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for… | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 24 Oct 2013 | Refreshe Lime Naturally Flavored Electrolyte Water, 12 bottles per cases, 1 L per bottle, sold under Safeway brand. The UPC 0 21130 24208 5. | The Sweetwater Co., Inc. | Food | Class II | 2 |
| 24 Oct 2013 | Tuna Salads- packaged in: 7 oz., 12 oz., 5 lb.10 lb and 30 lb containers Sold under the labels: Boston Salads and the Rachel's Gourmet and Dietz and Watson | Boston Salads & Provisions Co., Inc. | Food | Class I | 6 |
| 23 Oct 2013 | SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR… | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 23 Oct 2013 | Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched cassettes in a labeled kit box. Intended… | Alere San Diego, Inc. | Device | Class III | 1 |
| 23 Oct 2013 | Lam Sheng Kee HAW FLAKES, NET WEIGHT 380 g (13.4 oz), product is packaged in plastic bag with twenty four (24) bags per carton. UPC 6 949682 803780. Manufactured by LAM SHENG KEE (HK) INTERNATIONAL LIMITED, RM3/8F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: WIN LUCK TRADING INC 100 Pulaski… (66794) | A&C US Trading LLC | Food | Class II | 1 |
| 23 Oct 2013 | Nature's Way, UPC 33674149263, Alive Whole Food Energizer with Iron, 60 Tabs 20009807; Nature's Way, UPC 33674149270, Alive Whole Food Energizer with Iron, 90 Tabs 20009808. 33674149287 Alive Whole Food Energizer with Iron, 180 Tabs 20012063 | Schwabe North America, Inc. | Food | Class II | 13 |
| 22 Oct 2013 | Oma's Choice, Baby Dill Pickles, Net Wt. 16.oz., Made Espcially For Oma's Choice, 4042 F.M. 3171 Schulenburg, TX 78956. | Oma's Choice Inc | Food | Class II | 5 |
| 18 Oct 2013 | PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. | SpineFrontier, Inc. | Device | Class II | 1 |
| 18 Oct 2013 | AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units. | Steris Corporation | Device | Class II | 1 |
| 18 Oct 2013 | NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801731. *1st label indicates: Manufactured by: JINYYIFAN(HK)INTERNATIONAL LIMITED RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: CHANG RONG INTL… | Lsg Food World Inc | Food | Class II | 4 |
| 18 Oct 2013 | 1) 8" Coconut Custard Pie, Net Wt 22 oz (1 lb 6oz), UPC numbers 4173523721 and 4173522453, 2) 10" Coconut Custard Pie, Net Wt 42 oz (2 lb 10oz), UPC number 4173523713 (66548) | Price Chopper Supermarkets | Food | Class II | 1 |
| 17 Oct 2013 | Vitacost Mega Spectrum Enzyme, packaged with 180 Vegetarian Capsules, UPC Code: 84419701519. Manufactured for Vitacost Lexington, NC 27295 | Nature's Value Inc. | Food | Class II | 3 |
| 16 Oct 2013 | Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the… (66626) | Microgenics Corp | Device | Class II | 1 |
| 16 Oct 2013 | Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF… (66674) | Cutera, Inc. | Device | Class II | 1 |
| 16 Oct 2013 | Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-1351-8. | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class III | 1 |
| 15 Oct 2013 | Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 15 Oct 2013 | Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50 | VistaPharm, Inc. | Drug | Class II | 1 |
| 14 Oct 2013 | Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic… | Synthes (USA) Products LLC | Device | Class II | 1 |
| 11 Oct 2013 | HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and… | GE Healthcare, LLC | Device | Class II | 1 |
| 10 Oct 2013 | Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use. | Mizuho America, Inc. | Device | Class II | 2 |
| 9 Oct 2013 | Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. | Arrow International Inc | Device | Class II | 1 |
| 9 Oct 2013 | VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin). | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 9 Oct 2013 | Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes. | Arrow International Inc | Device | Class II | 1 |
| 9 Oct 2013 | Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 9 Oct 2013 | Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11 | Actavis Elizabeth LLC | Drug | Class II | 1 |
| 8 Oct 2013 | Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 7 Oct 2013 | Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological… | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 4 Oct 2013 | Turkey Hill Premium Chocolate Peanut Butter Cup Ice Cream Size 1 Pint (473 ml) packaged in a paper cup and lid, distributed by Turkey Hill Dairy, Conestoga, PA. | Turkey Hill Dairy, Inc. | Food | Class II | 3 |
| 3 Oct 2013 | STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high,… | Advanced Sterilization Products | Device | Class III | 1 |
| 3 Oct 2013 | Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The… | Lin-Zhi International Inc | Device | Class III | 1 |
| 3 Oct 2013 | Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 3 Oct 2013 | Market Pantry brand Animal Cookies, white fudge coated, in a clear plastic bear-shaped jar, net wt. 44 oz. Ingredients: enriched flour (wheat flour, malted barley flour, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), sugar, soybean oil, high fructose corn syrup, invert sugar, cocoa (processed… | D. F. Stauffer Biscuit Co, Inc. | Food | Class I | 1 |
| 2 Oct 2013 | Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. | Beckman Coulter Inc. | Device | Class II | 1 |
| 1 Oct 2013 | Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 1 Oct 2013 | Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products… (66596) | Omnyx Llc | Device | Class II | 1 |
| 1 Oct 2013 | ParaZYME, 90 capsules per bottle, is dietary supplement and sold under Renew Life brand. The UPC Code 6 31257 30990 7. The product is labeled in parts: "***PARAZYME***renew LIFE***The Digestive Care Company***90 Vegetable Capsules***Distributed by: ReNew Life Formulas***Palm Harbor, FL… | Pacific Nutritionals | Food | Class II | 3 |
| 30 Sep 2013 | Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 27 Sep 2013 | TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5… | Olympus America Inc. | Device | Class II | 1 |
| 25 Sep 2013 | Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 25 Sep 2013 | Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate. | Ethicon, Inc. | Device | Class II | 1 |
| 24 Sep 2013 | Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and… | Ebi, Llc | Device | Class II | 1 |
| 24 Sep 2013 | Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula, 4fFl.oz Tube, UPC code: 634084490091 (US) UPC Code: 634084490114 (Canada) | W.S. Badger Company Inc. | Drug | Class II | 2 |
| 24 Sep 2013 | Product #4124: Caramel dip in plastic containers | Gold Medal Products | Food | Class II | 2 |
| 20 Sep 2013 | Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA Laboratories, a division of Valeant Pharmaceuticals LLC, Bridgewater, NJ 08807 --- NDC 13548-132-03 (66356) | Valeant Pharmaceuticals North Am | Drug | Class III | 1 |
| 20 Sep 2013 | Garden-Fresh German Potato Salad, UPC 0 11596 14017 9, 16 oz, product code 4017 Code Date 9/25/2013 - 9/30/2013 | Garden-Fresh Foods, Inc. | Food | Class I | 63 |
| 19 Sep 2013 | Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 | Aesculap, Inc. | Device | Class II | 1 |
| 19 Sep 2013 | Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare… | GE Healthcare, LLC | Device | Class I | 1 |
| 18 Sep 2013 | Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 16 Sep 2013 | Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage Flip top Vial, (C-II), (NDC 0409-1135-02), Rx Only, Manfactured for Hospira, Inc., Lake Forest, IL 60045 USA. | Hospira, Inc. | Drug | Class II | 1 |
| 13 Sep 2013 | Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the… (66569) | Southern Implants, Inc | Device | Class II | 1 |
| 10 Sep 2013 | Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery. | Aesculap, Inc. | Device | Class II | 1 |
| 10 Sep 2013 | Sugar free cake: Carrot flavor, Package size: 4 oz, 12 oz. | Individual firm, name withheld | Food | Class III | 6 |
| 9 Sep 2013 | HCG Premium, Hormone-Free Drops 60 mL | Borinquen Natural | Food | Class II | 4 |
| 6 Sep 2013 | Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428 27364 7; (b) equate brand Lubricant… (66217) | Altaire Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 3 Sep 2013 | Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 3 Sep 2013 | (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 3 Sep 2013 | Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis Consumer Health, Inc, Lincoln, NE / There are 7 different labels under which this product is packaged but the active ingredient is the same. 1) DOLLAR GENERAL LABEL: DG Health Allergy Relief, Loratadine, USP 10 mg,… | Novartis Consumer Health | Drug | Class III | 1 |
| 27 Aug 2013 | GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic | Smith & Nephew Inc | Device | Class II | 6 |
| 20 Aug 2013 | iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological | Iba Dosimetry Gmbh | Device | Class II | 1 |
| 14 Aug 2013 | Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa | Fabscout Entertainment, Inc | Drug | Class I | 3 |
| 12 Aug 2013 | J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count tablets per blister pack, Order at: www.jackrabbitfourpack.com, Jack Rabbit Inc., 4355 Dow Road, Melbourne, FL 32934 (65895) | Jack Rabbit, Inc | Drug | Class I | 1 |
| 8 Aug 2013 | Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9359-07 | Novartis Pharmaceuticals Corp. | Drug | Class II | 15 |
| 5 Aug 2013 | Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle, Distributed by: Bethel, Inc., Tel: (212) 568-5330. | Bethel Nutritional Consulting, Inc | Drug | Class I | 2 |
| 2 Aug 2013 | Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01 | American Health Packaging | Drug | Class II | 1 |
| 1 Aug 2013 | Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 31 Jul 2013 | Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 31 Jul 2013 | 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 31 Jul 2013 | Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 31 Jul 2013 | Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 31 Jul 2013 | Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 31 Jul 2013 | B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017 | Healthy Life Chemistry Inc dba Purity First | Drug | Class I | 2 |
| 30 Jul 2013 | Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 30 Jul 2013 | Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 30 Jul 2013 | Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 30 Jul 2013 | Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 30 Jul 2013 | Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 30 Jul 2013 | Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 22 Jul 2013 | 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 19 Jul 2013 | Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com, DISTRIBUTED BY VOLCANO Long Beach, CA 90813, UPC 6 09613 85996 0. | Myson Corporation, Inc. | Drug | Class I | 2 |
| 17 Jul 2013 | Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment. | Hospira Inc. | Device | Class II | 1 |
| 17 Jul 2013 | Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326. | Apotex Inc. | Drug | Class II | 1 |
| 12 Jul 2013 | 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02 | Hospira Inc. | Drug | Class I | 2 |
| 28 Jun 2013 | Mediterranean Olives: Calcidica Sweet, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy | Ocean State Jobbers, Inc. | Food | Class II | 11 |
| 26 Jun 2013 | Woodstock Frozen Organic Pomegranate Kernels are sold in 8 oz. (227 gram) re-sealable plastic pouches with the UPC 0 42563 01628 9. The product is labeled in parts: "***WOODSTOCK***ORGANIC POMEGRANATE KERNELS***Juicy Lil' JEWELS***USDA ORGANIC***NET WT. 8 OZ (227g)***KEEP FROZEN***INGREDIENTS: Organic pomegranate… (65571) | Scenic Fruit Co | Food | Class I | 1 |
| 22 Jun 2013 | Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 21 Jun 2013 | Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz., Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Tween Brands Inc | Drug | Class III | 18 |
| 5 Jun 2013 | 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth. | 3M Company - Health Care Business | Device | Class III | 1 |
| 3 Jun 2013 | The Costco product is sold under brand name Townsend Farms Organic Antioxidant Blend - The product is a mix of IQF organic berries, specifically; dark tart cherries, pomegranate arils, strawberries, red raspberries, and blueberries. The product is packaged into plastic bags with a net wt. 48oz (3 lbs) 1.36kg. There… | Townsend Farms Inc | Food | Class I | 1 |
| 29 May 2013 | Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 28 May 2013 | 17-P 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | Individual firm, name withheld | Drug | Class I | 299 |
| 20 May 2013 | Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 15 May 2013 | Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III. | Cincinnati Sub-Zero Products Inc | Device | Class II | 1 |
| 10 May 2013 | syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 2 May 2013 | Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and… | Remel Inc | Device | Class II | 2 |
| 25 Apr 2013 | Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 11 Apr 2013 | KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL (65915) | mobility unlimited inc | Device | Class II | 1 |
| 4 Apr 2013 | 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial. | B. Braun Medical, Inc. | Device | Class II | 2 |
| 4 Apr 2013 | remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms. | Remel Inc | Device | Class II | 1 |
| 2 Apr 2013 | Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202-2); Kit w/14 g (NDC 10223-0202-3); 30 g bottle (NDC 10223-0202-4) Manufactured by Cetylite Industries, Inc., 9051 River Road Pennsauken, NJ 08110 - (66012) | Cetylite Industries, Inc. | Drug | Class II | 1 |
| 18 Mar 2013 | Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216 | Boehringer Ingelheim Roxane Inc | Drug | Class III | 1 |
| 12 Mar 2013 | Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. (65985) | Custom Ultrasonics, Inc. | Device | Class II | 1 |
| 22 Feb 2013 | Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6. | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 19 Feb 2013 | Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice. | Trumpf Medical Systems, Inc. | Device | Class II | 1 |
| 21 Nov 2012 | Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a… | Remel Inc | Device | Class III | 1 |
| 22 Oct 2012 | Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 6 937000 700019 | Zi Xiu Tang Success, LLC | Drug | Class I | 2 |
| 7 Sep 2012 | Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. | Synthes USA HQ, Inc. | Device | Class II | 2 |
| 19 Apr 2012 | The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is not intended for… | Ge Healthcare It | Device | Class II | 1 |
| 12 Apr 2012 | N4H RESEARCH Easy Protein 20 GRAMS OF PROTEIN PER SERVING NEUTRAL FLAVOR ALL NATURAL GLUTEN FREE 16 FL OZ Ingredients: Pure deionized water, Actinase [patent pending blend of enzymatically hydrolyzed (predigested) collagenic protein isolate, whey protein, isolate (milk) and casein protein isolate (milk)], pure cane… (63029) | N4h Research Llc | Food | Class II | 1 |
| 16 Mar 2012 | Korean Pear Juice in 120 mL metal foil pouch single service container. Made by Evergreen Orchard Farm, 1023 Yardville Allentown Road, Hamilton, NJ 08620. Product of USA. UPC# 809080300084. | Evergreen Orchard Farm, LLC | Food | Class II | 4 |