| 10 Mar 2015 | Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by MUTUAL PHARMACEUTICAL CO., INC., PHILADELPHIA, PA 19124 USA for Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Road, Cranbury, NJ 08512. NDC 53489-281-01 | Mutual Pharmaceutical Company, Inc. | Drug | Class II | 1 |
| 6 Mar 2015 | DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01. (70682) | Fusion Pharmaceuticals, LLC | Drug | Class II | 1 |
| 5 Mar 2015 | GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by… | GE Healthcare | Device | Class II | 1 |
| 5 Mar 2015 | 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. | Hospira Inc. | Drug | Class II | 1 |
| 4 Mar 2015 | LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapter 153 165mm (6 - 6 1/2 ) -Male pyramid… | Ossur H / F | Device | Class II | 1 |
| 27 Feb 2015 | Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15 | AVKARE Inc. | Drug | Class III | 2 |
| 27 Feb 2015 | Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16. | Akorn, Inc. | Drug | Class II | 1 |
| 26 Feb 2015 | Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01 | Pfizer Inc. | Drug | Class III | 2 |
| 25 Feb 2015 | LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to… | Biosense Webster, Inc. | Device | Class II | 1 |
| 25 Feb 2015 | Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31 | Heritage Pharmaceuticals, Inc. | Drug | Class II | 2 |
| 24 Feb 2015 | LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252 | LeMaitre Vascular, Inc. | Device | Class III | 1 |
| 23 Feb 2015 | Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable. | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class I | 1 |
| 23 Feb 2015 | PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC:… | Qualitest Pharmaceuticals | Drug | Class II | 1 |
| 23 Feb 2015 | Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05 | Sagent Pharmaceuticals Inc | Drug | Class II | 2 |
| 19 Feb 2015 | Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific. | Richard-Allan Scientific Company | Device | Class III | 1 |
| 17 Feb 2015 | Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the… | Synthes, Inc. | Device | Class II | 1 |
| 17 Feb 2015 | Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment. | Transonic Systems Inc | Device | Class II | 1 |
| 16 Feb 2015 | Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 16 Feb 2015 | GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or… | GE Healthcare | Device | Class II | 1 |
| 13 Feb 2015 | - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral… (70544) | Medela Inc. EF Division | Device | Class II | 1 |
| 13 Feb 2015 | AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 | Qualitest Pharmaceuticals | Drug | Class II | 1 |
| 13 Feb 2015 | Jack and the Beanstalk Soybean Sprouts and Natto Sprouts; Packaged in 1 lb., 1.5 lb. and 10 lb. packages. and Natto Soybean sprouts packed in 396 g. plastic bags (70525) | Hanbit Enterprises, Inc. dba Jack and the Beanstalk | Food | Class I | 1 |
| 13 Feb 2015 | Wal-Mart private label " the Bakery baked with pride," Sock It To Me Cr¿me Cake, Net Wt. 32oz (2lb) 907g, (packed in a rigid clear plastic dome), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. (70547) | Benson's Old Home Kitchens Bakery Division | Food | Class II | 1 |
| 13 Feb 2015 | Kirby Black Beans Creole Seasoning Net Wt. 29 oz. Packed for Kirby Foods Inc., Miami, Florida 33172 Product of Dominican Republic UPC 0 7738512346 4 | Goya Foods, Inc. | Food | Class II | 2 |
| 12 Feb 2015 | Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use. | Dako North America Inc. | Device | Class II | 1 |
| 12 Feb 2015 | Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA). | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 12 Feb 2015 | Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Made in India -- NDC 49884-902-52 (packets of 50 g) and NDC 49884-902-78 (cartons of five 50 g packets) | Par Pharmaceutical Inc. | Drug | Class II | 1 |
| 12 Feb 2015 | Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15 | Actavis Inc | Drug | Class II | 2 |
| 12 Feb 2015 | Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, powder, Net: 22 kg, Packaged in double plastic liners in a single fiber carton, For manufacturing, processing, or repackaging. Nano Technologies Corporation 1319 Marquettte Drive, Romeoville, IL 60446. NDC 10117-3004 (70568) | Nanophase Technologies Corporation | Drug | Class III | 1 |
| 12 Feb 2015 | LaRosa's Creamy Garlic Dressing, 1.5oz plastic packet. Labeled in part, "INGREDIENTS: Soybean Oil, Water, Vinegar, Red Wine (preserved with Sulfites)***Packed for LaRosa's Inc, Cincinnati, OH 45238" UPC 0 70200 80109 | T. Marzetti Company | Food | Class I | 2 |
| 11 Feb 2015 | SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 11 Feb 2015 | EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and… | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 11 Feb 2015 | Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500 (70551) | Sybron Dental Specialties | Device | Class II | 1 |
| 11 Feb 2015 | DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01. | Mylan Institutional LLC | Drug | Class III | 1 |
| 10 Feb 2015 | Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1. | Actavis Elizabeth LLC | Drug | Class II | 1 |
| 10 Feb 2015 | Product labeling is on the bottom of the container. Label reads in part "SMALL HEART STRAWBERRY TRAY WITH DEVONSHIRE DIP***Use By: 02/16/15 Net Weight 1.5# ***KEEP REFRIGERATED***" Product is packaged in a non flex plastic heart shaped container which is pink on the bottom and clear on the top. The container of… | Real Foods of Seattle, LLC | Food | Class I | 1 |
| 9 Feb 2015 | CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02 | CooperSurgical, Inc. | Device | Class II | 1 |
| 9 Feb 2015 | Mi Pepito Camaron Molido Ground Shrimp, Net wt. .75 oz (16 gr), Packaged in a plastic bag, Packed & Distributed by: N.A.C. Corp., Palisades Park, NJ, UPC 707425900051 (70533) | N.A.C. Foods | Food | Class II | 1 |
| 6 Feb 2015 | SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 6 Feb 2015 | Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0073-02, UPC 3 11917 15114 4. (70577) | Tarmac Products, Inc. | Drug | Class II | 1 |
| 6 Feb 2015 | Herdez Chilpotle Peppers, 7oz., Item No. 52738, UPC 072878285131 (70476) | MegaMex Foods, LLC - R&D Center | Food | Class II | 1 |
| 6 Feb 2015 | SOYBEAN SPROUTS Go-Hang Net Wt. 1 LBS.and 2 LBS.(Keep Refrigerated) TEL: (972)790-4800 1311LUKEST IRVING. TX.75061 Korean Food Co.; SOYBEAN SPROUTS Go-Hang NET. WT 10 LBS. (KEEP REFRIGERATED) Korean Food Grop 1311 LUKEST IRVING. TX.75061 (70475) | Korean Food Co. | Food | Class I | 1 |
| 6 Feb 2015 | Byglands, Non-GMO soybeans for Sprouting in 25KG bags and 1MT tote bags. (70550) | Soyko International, Inc | Food | Class I | 1 |
| 5 Feb 2015 | Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented. | Zimmer, Inc. | Device | Class II | 1 |
| 5 Feb 2015 | Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place. | Zipline Medical | Device | Class II | 3 |
| 5 Feb 2015 | ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work… | Arrow International Inc | Device | Class II | 1 |
| 5 Feb 2015 | Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England. | Remel Inc | Device | Class II | 1 |
| 4 Feb 2015 | Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty. (70664) | Individual firm, name withheld | Device | Class II | 1 |
| 4 Feb 2015 | Plain Bagels sold under the follow brand names and sizes: 1. Dan's Pantry Bagels 6 count, UPC 76057-00479, 2. Essential Everyday 5 count, Keep Refrigerated, UPC 41303-00683 3. Jewel 6 count, UPC 41280-01268, 4. Kroger 6 count, UPC 11110-02884 5. Kroger Mini 12 count, UPC 11110-02889 6. L'Oven Fresh 6 count, UPC… | Twin City Bagel, Inc. | Food | Class I | 11 |
| 3 Feb 2015 | LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 3 Feb 2015 | Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity… | Synthes, Inc. | Device | Class II | 1 |
| 3 Feb 2015 | IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm)… | Boston Scientific Corp | Device | Class I | 1 |
| 3 Feb 2015 | Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The product is intended for over the counter use as a toothbrush. The silver plating is an antimicrobial agent which maintains the cleanliness of the brush by preventing growth of bacteria on and between the filaments after use. (70456) | Norwex Usa Inc | Device | Class II | 1 |
| 3 Feb 2015 | Whole Foods Market Raw Macadamia Nuts packaged in 5.6 oz. clear plastic container with clear plastic lid; UPC: 7-23055-21415-3; 24 units per case | Whole Foods Market | Food | Class I | 1 |
| 2 Feb 2015 | EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component. | Microport Orthopedics INC. | Device | Class II | 1 |
| 2 Feb 2015 | COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological | Iba Dosimetry Gmbh | Device | Class II | 1 |
| 2 Feb 2015 | CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only. | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 2 Feb 2015 | Izzio Artisan Bakery Rev Lem/Poppy Muffins 3.5oz packaged individually and put into cardboard case with 90 muffins per case | Izzio Artisan Bakery, LLC | Food | Class II | 1 |
| 30 Jan 2015 | GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications. | GE Healthcare | Device | Class II | 1 |
| 30 Jan 2015 | Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) | Maquet Datascope Corp - Cardiac Assist Division | Device | Class II | 1 |
| 30 Jan 2015 | Pecanettes, Net Wt 8oz (226.80 Grams), Shelled and Packed by: Stone Mountain Pecan Co., 1781 Hwy 78, Monroe, GA 30656. (70422) | Stone Mountain Pecan Co | Food | Class I | 1 |
| 30 Jan 2015 | Market Basket Fork Split 6 count Original English Muffins UPC code: 0 49705 82137 4 | Flowers Foods | Food | Class I | 1 |
| 29 Jan 2015 | Elekta Precise Treatment Table | Elekta, Inc. | Device | Class II | 1 |
| 28 Jan 2015 | Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures. | Zimmer, Inc. | Device | Class II | 1 |
| 28 Jan 2015 | Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters… | Spacelabs Healthcare Inc | Device | Class II | 2 |
| 28 Jan 2015 | Similac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container. | Abbott Laboratories | Food | Class II | 1 |
| 28 Jan 2015 | Fairway - Like No Other Market Organic Cranberry Low Fat Granola Net Wt. 12 oz. (340 g) Manufactured for Fairway Group Holdings Group, New York, NY 10027 (70428) | Sole Grano Llc | Food | Class I | 1 |
| 27 Jan 2015 | ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 3 |
| 27 Jan 2015 | GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators. | GE Healthcare | Device | Class II | 1 |
| 27 Jan 2015 | Thai Delight Burrito, individually wrapped in clear plastic, keep refrigerated, serve hot or cold, Net wt. 11.5 oz (326g), UPC 7 94025 00190 5. The ingredients statement are listed "brown rice, peanut sauce (Peanuts, coconut milk, hot chili paste, turbinado, vegetable oil, garlic, onion, salt, lemon grass tamarind,… (70373) | The Lime Green Grocer, Inc. | Food | Class I | 1 |
| 27 Jan 2015 | Lindt Chocolate Specialties Milk Chocolate Covered Almonds,6.4 oz. packaged in a stand up bag (resealable pouch) Item Number: #8698 (or #8379) | Lindt & Sprungli USA | Food | Class I | 2 |
| 26 Jan 2015 | CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection | CooperSurgical, Inc. | Device | Class II | 4 |
| 25 Jan 2015 | Paleo Protein Bar Chocolate Brownie NET WT. 2.1OZ (60G) GMO-Free, Gluten-Free, No Sugar Alcohols Ingredients: Egg (White Protein, Isomalto-Olgosaccharide (Prebiotic Fiber), Organic Sunflower Seeds, Coconut Oil, Cold Presses Organic Palm Oil, Chocolate, Water, Vanilla, Orange Pulp, Monk Fruit, Sea Salt.… | Julian Bakery, Inc. | Food | Class I | 2 |
| 25 Jan 2015 | GROUND CUMIN STERILE TREATED PROD. OF TURKEY, 50 LBS. | Wm. E. Martin & Sons Co., Inc. | Food | Class I | 2 |
| 23 Jan 2015 | MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant 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… (70524) | Southern Implants, Inc | Device | Class II | 1 |
| 23 Jan 2015 | Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211 | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 23 Jan 2015 | Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 23 Jan 2015 | Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10 | Mylan Institutional LLC | Drug | Class III | 1 |
| 23 Jan 2015 | La Centro Americana COMINO MOLIDO Ground Cumin, Net Wt. 5 LBS held in clear plastic containers. Distributed by: La Centro Americana Corp. 2280 Union Blvd. Bay Shore, NY 11706 Tel. (631) 206-3097 (70408) | La Centro Americana Corporation | Food | Class I | 1 |
| 23 Jan 2015 | Go hyang Mak Kimchi 32 oz (UPC 042053138101) Product of U.S.A. TX. 972.790.4800 1311 Lukest, Irving, TX 75061; Go hyang Mak Kimchi 1/2 Gal (UPC 042053137302) Product of U.S.A. TX. 972.790.4800 1311 Lukest, Irving, TX. 75061 (70353) | Korean Food Co. | Food | Class I | 1 |
| 22 Jan 2015 | MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 22 Jan 2015 | Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311053 Legacy Part number: 478601 | Siemens Healthcare Diagnostics Inc | Device | Class II | 3 |
| 22 Jan 2015 | Queso Oaxaca Whole Milk Mozarella Cheese, Don Froylan brand, packaged in 12 oz., 1 lb., and 5 lbs. 12 oz. package has UPC 8 85790 00010 8; 1 lb. package has UPC 8 85790 00009 2; 5 lbs. bulk package has no UPC. (70413) | Ochoa's Queseria LLC | Food | Class II | 1 |
| 22 Jan 2015 | Coconut Easter Eggs | Chris A Papas & Son Co | Food | Class II | 13 |
| 21 Jan 2015 | Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 21 Jan 2015 | DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 (70464) | iCAD, Inc. | Device | Class II | 1 |
| 21 Jan 2015 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41616-219-90, UPC 3 41616 21990 6. | Sun Pharma Global Fze | Drug | Class II | 1 |
| 19 Jan 2015 | Dr. Praeger's Sensible Foods Bombay Curry Veggie Burgers 11 oz retail box Manufactured by Dr. Praeger's Sensible Foods Elmwood Park, NJ 07047 www.drpraegers.com Made in the USA UPC 80868 00050 (70367) | Ungar's Food Products, Inc. | Food | Class II | 1 |
| 19 Jan 2015 | Gourmet Sandwich Rolls sold under the Jewel brand and packaged with 8 rolls to a 20 oz. plastic transparent bag. | Gonnella Baking Co. | Food | Class I | 2 |
| 16 Jan 2015 | HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including… | HeartWare Inc | Device | Class I | 1 |
| 16 Jan 2015 | KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC. | Halyard Health | Device | Class II | 3 |
| 16 Jan 2015 | The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument) | Brainlab AG | Device | Class II | 1 |
| 16 Jan 2015 | Panela, Latin Style Soft Cheese, packaged in plastic wrap, Net Wt. 1 lb. The UPC is 6 10074 99341 4 | Individual firm, name withheld | Food | Class I | 5 |
| 16 Jan 2015 | Cardboard box contain 6 paper packets each labeled as: Fresh Food Manufacturing Company Firecracker Burger Kit Keep Refrigerated Mix By: 5/25/2015 (70308) | Fresh Foods Manufacturing Co. | Food | Class I | 1 |
| 16 Jan 2015 | Holiday Foods, Hors D'Oeuvre, 4802025 Vegetable Samosa Potsticker, 100 0.7 oz PCS , Food for institutional use only. | Schwan Food Company dba Holiday Foods | Food | Class II | 2 |
| 16 Jan 2015 | The World's Finest Mixed Fruit. Product is a combination of Red Delicious Apples, Granny Smith Apples and Navel Oranges. The product is packed in Poly bags 6/4 lb. bags per case. UPC 0 92304 XXXXX 4 is located on back of the poly bag next to the nutrition information, barcode on case is (01) 00033383006987(10). | Individual firm, name withheld | Food | Class I | 2 |
| 16 Jan 2015 | Streit's Kids Dark CHOCOLATE Coins, 24 x 0.5 oz (15g) mesh bags. UPC 70227 50121. PRODUCT OF TURKEY IMPORTED & DISTRIBUTED BY ARON STREIT INC. NEW YORK, NY 10002 USA. (70266) | Aron Streit Inc. | Food | Class I | 1 |
| 16 Jan 2015 | The product label reads in part "***Mount Mazama Lentil Chili***Rill Foods***NET WT. 15 OZ.***". The product is packaged in a clear flexible laminate bag and the spices in a separate bag within the bag. A card stock topper is attached to the top of the bag after filled. This card is purplish in color with white… | Rill Foods | Food | Class II | 5 |
| 15 Jan 2015 | TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back. | Invacare Corporation | Device | Class II | 3 |
| 15 Jan 2015 | N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system. | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 15 Jan 2015 | Frozen Shrimp Empanada, 100 count, Ready to cook, Item #K718, Prepared by Kabob's Acquisition Inc., 5423 North Lake Drive, Lake City, Ga. 30260. | Kabobs Inc | Food | Class II | 3 |
| 14 Jan 2015 | Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators. | INO Therapeutics (dba Ikaria) | Device | Class II | 1 |
| 14 Jan 2015 | Pacific Coast Selections Lime Chipotle Marinade, UPC 0 98487 10045 0; Saucy Mama Lime Chipotle Marinade, UPC 0 47281 40200 0; Product is packaged in clear, glass, 12 fluid ounce, ring neck bottle, with 38 mm black continuous thread closure covered with a black tamper evident shrink band. Cases of product are 6 packs. (70273) | Barhyte Specialty Foods Inc. | Food | Class II | 1 |
| 14 Jan 2015 | Chili-Bean Fresh Veggiburger, 4 Pre-Grilled Patties, All Natural Meatless Patties, Net Wt. 10 oz. (284)g) (70312) | J P Veggies Inc. DBA VeggieLand | Food | Class II | 1 |
| 13 Jan 2015 | ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures. (70348) | Med-logics Inc | Device | Class II | 1 |
| 13 Jan 2015 | H-E-B Homestyle White Corn Tortillas 12ct. and 30 ct. (70282) | H-E-B Corpus Christi Operations | Food | Class II | 1 |
| 12 Jan 2015 | Servo-I ventilator system CO2 analyzer. Part number 65 23 588. | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 9 Jan 2015 | The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead. The Medtronic InterStim II Neurostimulator, Model 3058, and Medtronic InterStim… (70271) | Individual firm, name withheld | Device | Class II | 1 |
| 9 Jan 2015 | NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, STERILE, Rx ONLY For single use only. ---Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems. | Navilyst Medical, Inc | Device | Class II | 60 |
| 7 Jan 2015 | Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400 | Biomet, Inc. | Device | Class II | 1 |
| 5 Jan 2015 | GROUND CUMIN SEED, 50 LBS NET, ETO STERILE TREATED (70186) | Morris J. Golombeck, Inc. | Food | Class I | 1 |
| 31 Dec 2014 | Gulf Coast Brand Cumin, NET WEIGHT 3.5 lbs (1.59 kg), GULF COAST BLENDERS, INC., NEW ORLEANS, LA | Gulf Coast Blenders, Inc | Food | Class I | 6 |
| 30 Dec 2014 | RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in… | Siemens Healthcare Diagnostics Inc | Device | Class II | 4 |
| 29 Dec 2014 | VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with VITROS Analyzer Systems. | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 29 Dec 2014 | Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025,… | Baxter Corporation Englewood | Device | Class II | 1 |
| 29 Dec 2014 | Caramel Apple labeled as Merbs Candies, Double Dipped, St. Louis individually wrapped in plastic | Sugar Daddy LTD | Food | Class I | 2 |
| 28 Dec 2014 | D.L. Jardine's MESQUITE BARBECUE SAUCE NET WT. 18 OZ. (510g) Distributed in Australia and New Zealand by Texan Imports Pty Ltd 19 Emperor Palace Kenthurst NSW 2156 Australia | Jardine Foods Inc | Food | Class I | 6 |
| 28 Dec 2014 | Seasoned Santa Fe Rice packed in 10 oz. (284 g) plastic film bags and sold under the Tommy's Superfoods brand or Western Rice packaged in 40 lb. corrugated boxes with blue poly liners and sold under the Tastee brand. Product is to be label to be kept frozen. (70134) | Harvest Food Group, Inc | Food | Class I | 1 |
| 28 Dec 2014 | Seasoned Santa Fe Rice packed in 10 oz. (284 g) plastic film bags and sold under the Tommy's Superfoods brand. Product is to be label to be kept frozen. (70140) | Individual firm, name withheld | Food | Class I | 1 |
| 26 Dec 2014 | Adams Pantry Basics Chili Powder Net Wt. 2.82 oz (80 g) UPC: 041313017224; Adams Pantry Basics Value Size Chili Powder Net Wt. 7.48 oz (212 g) UPC: 041313017231; Adams Pantry Basics Saver Size Ground Cumin Net Wt. 16.8 oz (477 g) UPC: 041313023522 | Adams Extract & Spice LLC | Food | Class I | 45 |
| 24 Dec 2014 | PURE GROUND CUMIN, Net Weight XXX Lbs. -- FIRST SPICE MIXING COMPANY - LONG ISLAND CITY, N. Y. | First Spice Mixing Co.,Inc. | Food | Class I | 15 |
| 23 Dec 2014 | FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701 | Hi-Tech Pharmacal Co., Inc. | Food | Class II | 1 |
| 23 Dec 2014 | Amaretto Hazelnut Ice Cream. Product can be packaged in 2.5 gallon or 1.5 gallon plastic tubs or cardboard quart container. Firm is unable to determine how batches were packaged. | Elevated Ice Cream Company | Food | Class I | 69 |
| 22 Dec 2014 | Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient. (70270) | Puritan Medical Products Co., LLC | Device | Class II | 1 |
| 19 Dec 2014 | Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615 (70388) | Angiodynamics | Device | Class II | 1 |
| 19 Dec 2014 | Focal Sim radiation therapy treatment planning system | Elekta, Inc. | Device | Class II | 1 |
| 19 Dec 2014 | Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation… | Elekta, Inc. | Device | Class II | 1 |
| 17 Dec 2014 | Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle… (70473) | Pivotal Health Solutions | Device | Class II | 1 |
| 17 Dec 2014 | CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty. | Zimmer Gmbh | Device | Class II | 5 |
| 17 Dec 2014 | Vegi-Chef Potato Knishes retail pack 1 lb. 8 oz. (680g), UPC 046676-91114-1 (70537) | Tovli, Inc. | Food | Class II | 1 |
| 16 Dec 2014 | Weis Veggie Chips Net Wt. 6 oz. Packed For Weis Markets, Inc. Sunbury, PA 17801 With code dates: 10 Dec 2014 thru 7 Apr 2015 Natures Place Veggie chips Net Wt. 6 oz Distributed By: DZA Brands, LLC, Salisbury NC 28147/Scarborough, ME 04074 With code dates: 15 Dec 2014 thru 10 Apr 2014 Market Basket Veggie Chips Net… | Keystone Food Products Inc | Food | Class III | 2 |
| 15 Dec 2014 | Pacific Fusion Frozen Tuna Steak Wild Caught Net Weight: 15 lb (240oz) 6.80 kg Ingredients: Tuna, tasteless smoke used as a preservative to promote color retention SKU: 0 75627 14610 3 Production Date: 10 MAR 2014 Best Before: 10 MAR 2016 Manufactured By: Thai Ocean Venture Co. 64/213 moo 7, Anupas phuketkan Rd.… (70047) | Thai Ocean Venture Co., Ltd. | Food | Class II | 1 |
| 14 Dec 2014 | Juno DFR X-ray system | Villa Radiology Systems LLC | Device | Class II | 1 |
| 10 Dec 2014 | The I-Cart is used to store, transport, and power video equipment used in medical procedures. | Richard Wolf Medical Instruments Corp. | Device | Class II | 1 |
| 4 Dec 2014 | Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540 | Micro Labs Usa, Inc S | Drug | Class III | 3 |
| 3 Dec 2014 | RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications. | Arjo Hospital Equipment AB | Device | Class II | 3 |
| 25 Nov 2014 | TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use in cardiac electrophysiological mapping and… | St Jude Medical | Device | Class II | 1 |
| 20 Nov 2014 | SMOKED NOVA Salmon, NET WT 4 oz (113g). Product is held in vacuum packs with black, beige and yellow labeling. Distributred by ACME Smoked Fish Corp. Brooklyn, NY 11222. PRODUCT OF DENMARK. (69871) | Acme Smoked Fish Corp. | Food | Class I | 1 |
| 19 Nov 2014 | ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 10 Nov 2014 | CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory… | Medtronic MiniMed Inc. | Device | Class III | 1 |
| 29 Oct 2014 | Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb,… | Radiometer America Inc | Device | Class II | 1 |
| 10 Oct 2014 | Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date. (70143) | US Infusion Inc dba Trucare Biomedix-USA | Device | Class II | 1 |
| 16 Sep 2014 | Roach dry eviscerated salted Fish (Rutilus rutilus), Weight 0.365 Kg. Product is held in plastic packaging & shipped in 5 Kg (11 lb) boxes. Imported by: B&I Overseas Trading Inc, Van Nuys, California 91406. Distributed By: S and S Food Import Corp. 5337 Preston Court, Brooklyn, NY 11234 (www.ssfoodimport.com).… (69281) | S&S Food Import Corp. | Food | Class I | 1 |
| 8 Sep 2014 | Xoran MiniCAT X-ray imaging device (69939) | Xoran Technologies, LLC | Device | Class II | 1 |
| 1 Sep 2014 | Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress. | Arjo Hospital Equipment AB | Device | Class II | 1 |
| 8 Aug 2014 | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline BARD MYPICC… | Bard Access Systems | Device | Class II | 5 |
| 2 Jul 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes… | Hospira Inc. | Device | Class I | 5 |
| 26 Jun 2014 | TranSmart Raspberry Filled frozen unbaked cookie dough, 108/1.75 oz. units, CSM Bakery Products, 3301 Montreal Industrial Way Tucker, GA 30084.. (68761) | CSM Bakery Products NA-Atlanta Frozen | Food | Class I | 1 |
| 6 Jun 2014 | Philips Medical System Allura Xper X-Ray Angiographic | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 3 Apr 2014 | AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 8 Nov 2013 | Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS | Arrow International Inc | Device | Class II | 1 |
| 16 Oct 2013 | The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 14 Oct 2013 | Philips Multi Diagnost Eleva II | Philips Medical Systems, Inc. | Device | Class II | 2 |
| 18 Feb 2013 | The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare… | GE Healthcare | Device | Class II | 1 |
| 30 Nov 2012 | Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across… | Biomet Spine, LLC | Device | Class II | 1 |
| 11 Apr 2012 | Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. | Siemens Medical Solutions USA, Inc. | Device | Class II | 2 |