| 17 Jul 2014 | Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1. | X-Gen Pharmaceuticals Inc. | Drug | Class III | 1 |
| 11 Jul 2014 | Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540. | Sandoz Inc | Drug | Class III | 1 |
| 9 Jul 2014 | Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L | Integra LifeSciences Corp. | Device | Class II | 1 |
| 9 Jul 2014 | Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier. | Teleflex Medical | Device | Class II | 2 |
| 9 Jul 2014 | QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. | Philips Ultrasound, Inc. | Device | Class II | 2 |
| 8 Jul 2014 | VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70 | Pfizer Inc. | Drug | Class III | 1 |
| 7 Jul 2014 | GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. | GE Healthcare, LLC | Device | Class II | 1 |
| 7 Jul 2014 | Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. | Innovasis, Inc | Device | Class II | 1 |
| 3 Jul 2014 | Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60. | Fougera Pharmaceuticals Inc. | Drug | Class III | 2 |
| 3 Jul 2014 | Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class III | 1 |
| 3 Jul 2014 | UltraBalance Protein Powder, Net Wt. 14.8 oz (420g) (68698) | Metagenics, Inc. | Food | Class II | 1 |
| 1 Jul 2014 | InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use. (68709) | Biogenex Laboratories, Inc. | Device | Class II | 1 |
| 30 Jun 2014 | Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients. | Steris Corporation | Device | Class III | 1 |
| 30 Jun 2014 | Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 27 Jun 2014 | The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures. | Steris Corporation | Device | Class II | 1 |
| 27 Jun 2014 | Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61. | Hospira Inc. | Drug | Class II | 1 |
| 27 Jun 2014 | H¿agen-Dazs Chocolate Chocolate Chip Ice Cream, 14 oz, UPC of 74570-08400 (68676) | Nestle | Food | Class I | 1 |
| 26 Jun 2014 | Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3). | Alphatec Spine, Inc. | Device | Class II | 1 |
| 26 Jun 2014 | POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16. | Poly Pharmaceuticals, Inc | Drug | Class III | 2 |
| 25 Jun 2014 | Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006 | Zimmer, Inc. | Device | Class II | 1 |
| 25 Jun 2014 | Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family. | Invacare Corporation | Device | Class II | 1 |
| 25 Jun 2014 | Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit. (68646) | Individual firm, name withheld | Device | Class II | 1 |
| 25 Jun 2014 | Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use. | Salter Labs | Device | Class II | 1 |
| 24 Jun 2014 | MK5 NX Controller--Wheelchair controller | Invacare Corporation | Device | Class II | 1 |
| 23 Jun 2014 | BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 23 Jun 2014 | BBQ Pull-A-Part Bread (Brands: Sunbeam (UPC 0 77633 05303 1), Bunny (UPC 0 71025 01500 3), Flowers [Foodservice] (UPC 0 72250 01866 1) and Ingles (UPC 0 86854 01543 8), 16oz clear flexible plastic bags, Distributed by Flowers Bakeries, LLC, Thomasville, GA 31757. | Flowers Foods | Food | Class I | 1 |
| 20 Jun 2014 | Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103. (68659) | Individual firm, name withheld | Device | Class II | 1 |
| 20 Jun 2014 | LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology (68674) | Laser Peripherals LLC | Device | Class II | 1 |
| 20 Jun 2014 | Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use. (68624) | Individual firm, name withheld | Device | Class II | 1 |
| 20 Jun 2014 | Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL (68592) | ORIGIO, Inc | Device | Class II | 1 |
| 20 Jun 2014 | Hula Brand Products; Hana Ebi Red; artificially colored shrimp flakes); Packed in 1 lb. (545 g) and 6 oz. packages. Servins size 2 pinches (1 g) Manufactured by Modern Macaroni Co., Honolulu, HI Serving size is "2" pinches | Modern Macaroni Co Ltd | Food | Class III | 2 |
| 19 Jun 2014 | Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07. | Forest Pharmaceuticals Inc | Drug | Class II | 1 |
| 19 Jun 2014 | Velveeta Original Pasteurized Ripe Cheese Product sold under the Kraft brand and individually wrapped in plastic and sold in a card stock carton with a net weight of 2 lb. (32 oz.). | Kraft Foods Group | Food | Class II | 1 |
| 19 Jun 2014 | Walnut Creek Farmers Cheese- 6lbs in plastic bags- 4 per case | Pearl Valley Cheese Inc | Food | Class II | 4 |
| 19 Jun 2014 | Country Life TARGET MINS CALCIUM MAGNESIUM With Vitamin D3 Complex, WILD BLUEBERRY FLAVOR, LIQUID Dietary Supplement, 16 FL. OZ. (1 PINT) (472 mL), Product No. 2523, Bar Code 015794025238, and 32 FL. OZ. (1 QT) (944 mL), Product No. 2522, Bar code 015794025221 --- Manufactured for Country Life, LLC 180 Vanderbilt… (68597) | Country Life | Food | Class II | 1 |
| 18 Jun 2014 | Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 18 Jun 2014 | GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 18 Jun 2014 | Item: 4815 Land O'Lakes, Extra Melt American White, Pasteurized Process American Cheese, Net WT 5 lbs (2.26 KG) | Land O' Lakes, Inc | Food | Class II | 4 |
| 17 Jun 2014 | Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 17 Jun 2014 | Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS) | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 17 Jun 2014 | SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458 | CareFusion 303, Inc. | Device | Class II | 1 |
| 17 Jun 2014 | Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58 | Teva Pharmaceuticals USA | Drug | Class III | 4 |
| 16 Jun 2014 | Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan. | Nidek Inc | Device | Class II | 1 |
| 16 Jun 2014 | Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61. | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 14 Jun 2014 | Wegmans Cinnamon Raisin Buns, NET WT. 12 OZ (340g), UPC 77890 92218 ---Baked by Wegmans Food Markets Inc. - Rochester, NY 14603 | Wegmans Food Markets, Inc. | Food | Class I | 1 |
| 13 Jun 2014 | Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability. (68609) | Dental EZ Group Star Dental Division | Device | Class II | 1 |
| 13 Jun 2014 | GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. | GE Healthcare, LLC | Device | Class II | 1 |
| 13 Jun 2014 | Ingenia 3.0T R5, magnetic resonance imaging system. | Philips Medical Systems, Inc. | Device | Class II | 4 |
| 13 Jun 2014 | Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures | Aesculap, Inc. | Device | Class II | 1 |
| 13 Jun 2014 | Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086 | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 13 Jun 2014 | Vita Classic Premium Sliced Smoked Atlantic Nova Salmon, packaged in a black vacuum-sealed, plastic film package for retail sale. Product is labeled "ready to serve" and each package contains 4 ounces of product. | Vita Food Products, Inc. | Food | Class I | 1 |
| 13 Jun 2014 | Schnucks Bakery 8" Devil's Food Cake, net wt. 2 lb 13 oz, UPC: 04131831186. Also packaged as Schnucks Bakery Half Devil's Food Cake, net wt. 1 lb 7 oz plastic, UPC: 04131831078 Schnuck Markets, Inc., St. Louis, MO. (68554) | Schnucks Markets Inc | Food | Class II | 1 |
| 12 Jun 2014 | Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil… (68703) | Heartsine Technologies, Limited | Device | Class II | 1 |
| 12 Jun 2014 | EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract. | Pentax Medical Company | Device | Class II | 1 |
| 12 Jun 2014 | Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process. | Zimmer Manufacturing B.V. | Device | Class II | 1 |
| 12 Jun 2014 | Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC. | Medical Action Industries Inc | Device | Class II | 8 |
| 12 Jun 2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. 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.… | Caraco Pharmaceutical Laboratories, Ltd. | Drug | Class II | 1 |
| 12 Jun 2014 | Gouda Cheese wheels, Whole Wheels 10 lbs and Half Wheels 5 lbs., packaged under the the brand names: Mountain Gouda and Smiths Farmstand (68543) | Smith's Country Cheese, Inc. | Food | Class I | 1 |
| 11 Jun 2014 | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients. | GE Healthcare, LLC | Device | Class I | 1 |
| 11 Jun 2014 | Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS. | Remel Inc | Device | Class II | 1 |
| 11 Jun 2014 | IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc. | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 11 Jun 2014 | Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a… | PIONEER SURGICAL TECHNOLOGY, INC. | Device | Class II | 1 |
| 11 Jun 2014 | Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU 90520UK - LED Headlight w/Battery &… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 11 Jun 2014 | Mountain House Freeze-Dried Precooked Scrambled Eggs with Ham and Red & Green Peppers, 19.4 oz 1 LB 3.4 oz), packed in #10 metal can. Product is labeled in part "***INGREDIENTS: Precooked Scrambled Eggs* (whole eggs, egg yolk, nonfat dry milk, modified corn starch, corn oil, salt, yeast extract, sunflower oil, smoke… (68525) | Oregon Freeze Dry, Inc. | Food | Class II | 1 |
| 10 Jun 2014 | EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a… | Baxter Healthcare Corp. | Device | Class II | 1 |
| 10 Jun 2014 | WEGMANS ICE in plastic bags; NET WT. 7 LBS (UPC 77890 29197) and NET WT 18 LBS (UPC 77890 29200) --- WEGMANS FOOD MARKETS INC. ROCHESTER, NEW YORK | Wegmans Food Markets, Inc. | Food | Class II | 1 |
| 9 Jun 2014 | RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular… | Nidek Inc | Device | Class II | 1 |
| 9 Jun 2014 | Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics Inc. | Device | Class II | 1 |
| 9 Jun 2014 | 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle. | 3M Company - Health Care Business | Device | Class II | 1 |
| 9 Jun 2014 | MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws | Integra LifeSciences Corp. | Device | Class II | 1 |
| 9 Jun 2014 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region. | Individual firm, name withheld | Device | Class I | 5 |
| 9 Jun 2014 | Echinacea Agustifolia Root PE 4:1 The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg. | Naturex Inc. | Food | Class III | 3 |
| 9 Jun 2014 | Hot smoked Coho salmon; Gold foiled, vacuum packaged units, approximately ¿ pounds each. Adhesive label affixed to front or back of package. Label reads in part, "**Smoked Coho INGREDIENTS, SALMON CURED WITH WATER, DEXTROSE, FLAVORING, SODIUM NITRITE. PROCESSED BY SUNRISE MEATS***PORT ANGELES WASHINGTON***REFRIGERATE… (68504) | Sunrise Meats, Inc. | Food | Class II | 1 |
| 8 Jun 2014 | Dole Garden Soup "Roasted Garlic Tomato Basil", Net Wt. 26 oz. (1lb 10oz) 737 g, UPC 3890002404, 6 units/case | Dole Packaged Foods, Llc | Food | Class I | 1 |
| 6 Jun 2014 | Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 6 Jun 2014 | The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare professionals with the capability to send,… | Hospira Inc. | Device | Class II | 1 |
| 6 Jun 2014 | BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics. | BD Biosciences, Systems & Reagents | Device | Class II | 1 |
| 6 Jun 2014 | AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest,… | AGFA Corp. | Device | Class II | 1 |
| 6 Jun 2014 | Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62 | Hospira Inc. | Drug | Class II | 1 |
| 6 Jun 2014 | DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France | Estee Lauder Inc | Drug | Class III | 1 |
| 6 Jun 2014 | GreenSmoothieGirl TriOmega Superfood, GreenSmoothieGirl Sprouted Ground TriIOmega Superfood, Packaged in metalized resealable standup pouches in 1-pound units (68484) | Individual firm, name withheld | Food | Class I | 1 |
| 6 Jun 2014 | Egg White Salad with Chives, 6 oz., packaged in round plastic containers with film seals and snap lids under the Trader Joe's brand. This is a ready-to-eat refrigerated deli salad sold at retail locations. (68515) | Hot Mama's Foods | Food | Class I | 1 |
| 5 Jun 2014 | Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer (68573) | Excelsior Medical Corp | Device | Class II | 1 |
| 5 Jun 2014 | Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor . | Teleflex Medical | Device | Class II | 15 |
| 5 Jun 2014 | Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed… | Axcentria Pharmaceuticals, LLC | Device | Class II | 1 |
| 5 Jun 2014 | Dark Old Fashioned Sponge Candy, sold under the following brand and sizes: 1. Eillien's in Net Wt. 6 oz (170g) UPC 34952-12994, 10 oz. (284g) UPC 34952-56927, 12 oz. (340g) UPC 34952-57307. 2. Blain's Farm & Fleet Net Wt. 14oz. (397g), UPC 34952-81171 3. Mae's Corner Market Net Wt. 14oz. (397g) UPC 34952-41075, 1 lb.… | Eillien's Candies, Inc. | Food | Class I | 1 |
| 5 Jun 2014 | Kirkland Signature Coarse Ground Malabar Pepper, 12.7 oz Plastic Jars, UPC 096619164998. Packaging includes a PET bottle. The lid is made of Polypropylene and contains a tinplate insert and a Polypropylene five-hole cap. The label on the jar is a rectangular label (front and back) information is superimposed over an… | Olde Thompson, Inc. | Food | Class I | 1 |
| 5 Jun 2014 | Sharp Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce cups with snap-on lid (14001), 14 ounce cups with snap on lid (17001), 10 lb. pail with snap on lid (12341). 2. Central Markets in 8 oz cups with snap on lid (27056). 3. Cobblestone Market in 5 lb.… | Parkers Farm Inc | Food | Class II | 8 |
| 5 Jun 2014 | The Cookies Cottage (Brand) Crispy Taro Cookies (Toasted Vegetarian Yam Biscuits), 180g. Packaged in 24packets per carton. (68550) | U-Can Food Trading Inc | Food | Class II | 1 |
| 4 Jun 2014 | PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. The filters are individually packaged in a clear, plastic pouch with black writing - 50 per case, or in bulk packaged 100 filters/bag and two bags per shipper for a total of 200… (68424) | Pall Corporation | Device | Class II | 1 |
| 4 Jun 2014 | GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is 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, LLC | Device | Class II | 2 |
| 4 Jun 2014 | Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis. | Blue Belt Technologies MN | Device | Class II | 2 |
| 4 Jun 2014 | Ocean Spray¿ Greek Yogurt Covered Craisins¿ Dried Cranberries , 8 oz Resealable Pouch UPC: #23719 (68458) | Ocean Spray Cranberries Inc. | Food | Class I | 1 |
| 4 Jun 2014 | Ferrous Gluconate Tablets, 5gr (325 mg), Elemental Iron 36 mg, 100 Tablets, UPC 0 79854 50032 5 (68467) | National Vitamin Co Inc | Food | Class II | 1 |
| 3 Jun 2014 | ACL TOP (Base), automated coagulation laboratory instrument. | Instrumentation Laboratory Co. | Device | Class II | 7 |
| 3 Jun 2014 | Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities. | Nellcor Puritan Bennett Inc. (dba Covidien LP) | Device | Class II | 1 |
| 3 Jun 2014 | ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 3 Jun 2014 | CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients. | Nihon Kohden America Inc | Device | Class II | 1 |
| 3 Jun 2014 | RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation. | DePuy Orthopaedics, Inc. | Device | Class II | 3 |
| 3 Jun 2014 | waxed paperboard int container of frozen ice cream labeled Thrifty Ice Cream Mint 'N' Chip 1 Pint (16 Fl. OZ.) Bottom of container Expiration Date: October 28 2015 Lot #24273 Back of container UPC 1182264327 (68465) | Rite Aid HDQTRS. Corp. | Food | Class I | 1 |
| 2 Jun 2014 | Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 2 Jun 2014 | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue | Smith & Nephew, Inc. Endoscopy Division | Device | Class II | 5 |
| 2 Jun 2014 | MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 2 Jun 2014 | Roselani Tropics Kona Mud Mud Pie Ice Cream: 1.75QT, - 56 oz. carton. Maui Soda & Ice Works, Ltd. Wailuku, HI (68464) | Maui Soda & Ice Works Ltd/dba Roselani Ice Cream | Food | Class II | 1 |
| 30 May 2014 | Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using… | Alere San Diego, Inc. | Device | Class III | 1 |
| 30 May 2014 | ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790 | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 30 May 2014 | Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045 | Individual firm, name withheld | Drug | Class II | 6 |
| 30 May 2014 | Mt. Olive, PepperPAK Jalapeno Slices, 4-3.7fl oz cups, Net fl oz 14.8 (438 ml), Mt Olive Pickled Co., Inc., Corner of Cucumber and Vine, P.O. Box 609, Mt. Olive, NC 28365-0609. (68438) | Mt. Olive Pickle Company Inc | Food | Class III | 1 |
| 30 May 2014 | Plank Road Round (Pasteurized Cows Milk Cheese).4 oz. plastic sealed with protective band. | Individual firm, name withheld | Food | Class II | 2 |
| 30 May 2014 | Brunkow Cheese of Wisconsin, Monterey Jack Morel Mushroom & Onion Cheese, 5 lb block plastic wrapped and vacuum sealed. Eight blocks per case. Ingredients: Cultured Pasteurized Whole Milk, Salt, Microbial Enzymes, Morel Mushroom and Onion. (68446) | Brunkow Cheese of Wisconsin, Inc. | Food | Class III | 1 |
| 30 May 2014 | Rosemary & Olive Oil Gluten Free Snack Crackers sold under the following brand names and sizes: 1. glutino, Net Wt. 4.25 oz (120g) UPC 78523-03861; 2. glutino, 2 count 10 oz bags, Net Wt. 20 oz (566 g) UPC 78523-03863; 3. Aldi's brand live G free, Net Wt. 4.25 oz (120g) UPC 41498-20371 | Baptista's Bakery, Inc | Food | Class I | 1 |
| 29 May 2014 | STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches | B. Braun Medical, Inc. | Device | Class II | 1 |
| 29 May 2014 | MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed. | Elekta, Inc. | Device | Class II | 1 |
| 29 May 2014 | Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument. | Synthes, Inc. | Device | Class II | 1 |
| 29 May 2014 | Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 29 May 2014 | Coca Cola Vanilla, 12 pack/12 fl oz cans, UPC: 49000 03124, Canned under authority of the Coca Cola Company, Atlanta, GA 30313 By a member of the Coca Cola Bottlers Association, Atlanta, GA. | The Coca-Cola Company | Food | Class III | 1 |
| 28 May 2014 | Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide… (68581) | Shape Medical Systems, Inc | Device | Class II | 1 |
| 28 May 2014 | Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding. | Baxter Corporation Englewood | Device | Class II | 1 |
| 28 May 2014 | HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and… | Nitinol Devices and Components, Inc. | Device | Class I | 12 |
| 28 May 2014 | 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. | Vascular Technology, Inc. | Device | Class II | 4 |
| 28 May 2014 | Navitas Naturals Organic Sprouted Chia Powder, 8 oz (227g) package; Omega Fatty Acids, Protein, dietary Fiber. UPC 858847000369; Navitas Naturals, Novato, CA 94949 | Navitas, LLC., dba Navitas Naturals | Food | Class I | 3 |
| 27 May 2014 | FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is growing in the blood culture. The following… (68352) | BioFire Diagnostics, Inc. | Device | Class II | 1 |
| 27 May 2014 | Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies. | Vascular Solutions, Inc. | Device | Class I | 1 |
| 27 May 2014 | Large Pitted Kalamata Olives, packaged in 4.4lb black plastic barrels. Labeling reads in part: Savor Greek Large Pitted Kalamata Olives, refrigerate after opening, these olives are mechanically pitted and may contain pit fragments, DR WT 4.4LBS (2kg) (68423) | Dot Foods Inc. | Food | Class II | 1 |
| 23 May 2014 | RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway. | Teleflex Medical | Device | Class II | 1 |
| 23 May 2014 | Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper… | Zimmer, Inc. | Device | Class II | 3 |
| 23 May 2014 | RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement… | Siemens Healthcare Diagnostics Inc | Device | Class II | 1 |
| 23 May 2014 | Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. | Terumo Cardiovascular Systems Corporation | Device | Class II | 13 |
| 23 May 2014 | Oceans Cuisine brand CRAB STUFFING WITH REAL CRABMEAT, NET WEIGHT 3 LBS. (48 oz.) UPC 7 30692 00031 5, PRODUCT OF USA --- PACKED BY: OCEANS CUISINE LTD. FARMINGDALE, NY 11735 --- The product is packaged in plastic tub containers, 2 x 3 lb. containers per case (68432) | Oceans Cuisine, LTD. | Food | Class I | 1 |
| 23 May 2014 | California Grown Shelled Walnuts, Net Weight 12 oz (340g), UPC 69887507806 46 cases, 24 count, 12 oz packages. (68385) | Suntree LLC | Food | Class I | 1 |
| 22 May 2014 | Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network, | Siemens Healthcare Diagnostics Inc | Device | Class III | 1 |
| 22 May 2014 | GSF LLC Shelled Walnuts, Kernel Combo Halves & Pieces, 15% New Wt. 25 lbs. GSF LLC, Visalia, CA 93290 (68376) | GSF Nut Company LLC | Food | Class I | 1 |
| 22 May 2014 | Ocean's Catch RTE Fresh Hand Picked Crabmeat , Net WT. 6 oz. plastic container Ingredients; Contains Jonah Crab Meat | Rome Packing Co., Inc. | Food | Class I | 3 |
| 21 May 2014 | Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior,… (68362) | SeaSpine Inc | Device | Class II | 1 |
| 21 May 2014 | BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative… | Becton Dickinson & Co. | Device | Class III | 1 |
| 21 May 2014 | System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System. | Intuitive Surgical, Inc. | Device | Class II | 12 |
| 20 May 2014 | syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 20 May 2014 | Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC… | West-Ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 19 May 2014 | Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver. (68405) | Individual firm, name withheld | Device | Class II | 1 |
| 19 May 2014 | V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 19 May 2014 | VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581 | Zimmer, Inc. | Device | Class II | 1 |
| 19 May 2014 | Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 19 May 2014 | NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. | Zimmer, Inc. | Device | Class II | 9 |
| 19 May 2014 | Label reads in part "Annie Mac's Baking Co. Coconut Macaroon, "The coconut macaroon is dipped in chocolate, heat sealed in plastic." Net Wt. 12 oz. Product is wrapped in cellophane (68338) | Annie Mac's Baking Company | Food | Class I | 1 |
| 16 May 2014 | Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual resuscitator for the… (68242) | Ventlab LLC | Device | Class I | 1 |
| 16 May 2014 | Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids… | Alcon Research, Ltd. | Device | Class II | 1 |
| 16 May 2014 | Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20 | Hospira Inc. | Drug | Class II | 1 |
| 16 May 2014 | Fat free cottage cheese sold under the Knudsen or Kraft brand and packaged in a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g, or a plastic container with a net weight of 32 oz. (2 lb.) 907 g. | Kraft Foods Group | Food | Class II | 11 |
| 15 May 2014 | DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications. | Biomet, Inc. | Device | Class II | 1 |
| 15 May 2014 | Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 15 May 2014 | Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B… | Focus Diagnostics Inc | Device | Class II | 1 |
| 15 May 2014 | Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic. | Synthes, Inc. | Device | Class II | 1 |
| 15 May 2014 | Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14 | Franck's Lab Inc dba Trinity Care Solutions | Drug | Class II | 30 |
| 14 May 2014 | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a… | NxStage Medical, Inc. | Device | Class II | 8 |
| 13 May 2014 | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments. | DeVilbiss Healthcare LLC | Device | Class III | 1 |
| 12 May 2014 | Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 | Microline Surgical, Inc. | Device | Class II | 2 |
| 9 May 2014 | ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated. (68384) | VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH | Device | Class II | 1 |
| 9 May 2014 | Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 9 May 2014 | Marissa Collection Tangerine Appetizer Plate Set (set of 2). distributed by Princess House Inc., Taunton, MA (68044) | Princess House Inc. | Food | Class III | 1 |
| 8 May 2014 | Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery. | Covidien LLC | Device | Class II | 1 |
| 8 May 2014 | Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 8 May 2014 | HAQUE brand GOLDEN RAISINS, WT 7 OZ. --- SURMA DISTRIBUTORS LLC Brooklyn, NY 11237 --- Nutrition Facts: Serving Size 1/4 tsp (0.5 g), Servings 204 (68278) | Surma Distributors Llc | Food | Class I | 1 |
| 6 May 2014 | Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 5 May 2014 | ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the… (68196) | DIABETIC SUPPLY OF SUNCOAST, INC. | Device | Class I | 1 |
| 5 May 2014 | Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA | Axcentria Pharmaceuticals, LLC | Drug | Class II | 1 |
| 5 May 2014 | Certified Organic, Owl Canyon Whole Eggs, packed in one dozen and half-dozen cardstock packages, with a packing date of 93, 94, 97, or 98. (68189) | Six Dog, LLC | Food | Class I | 1 |
| 2 May 2014 | Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02 | Fresenius Kabi USA, LLC | Drug | Class II | 2 |
| 2 May 2014 | Barricini Milk Chocolate Peanut Butter Pretzels in Net Wt 6.5 oz. plastic tub, UPC 075655235181 Back Panel: Milk Chocolate Peanut Butter Cups Barricini Manufactured by Bazzini Holdings, LLC Allentown, PA 18106 (68316) | Bazzini Holdings L.L.C. | Food | Class II | 1 |
| 1 May 2014 | Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using the existing Triathlon Patella Resection… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 1 May 2014 | Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 1 May 2014 | Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41. | Boehringer Ingelheim Roxane Inc | Drug | Class II | 1 |
| 29 Apr 2014 | Yangban Rice Porridge with Abalone, Net Wt. 10.16 oz (288 g), UPC 8 83298 61617 3, 24 cans/case (68160) | HK GALLERIA WHOLESALE L.P | Food | Class II | 1 |
| 28 Apr 2014 | Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus. | Atrium Medical Corporation | Device | Class II | 1 |
| 23 Apr 2014 | e.cam camera system. Emission Computed Tomography 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. Nuclear medicine diagnostic device. | Siemens Medical Solutions USA, Inc. | Device | Class II | 2 |
| 23 Apr 2014 | Floribbean Key Lime Calypso Dip 12.5 oz Floribbean 68 SW 40 St. Suite 411 Miami, Florida 33155 1(800)282-8459 (68005) | Miami Interculinary Center, Inc. | Food | Class I | 1 |
| 22 Apr 2014 | illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions. | Meridian Bioscience Inc | Device | Class II | 1 |
| 16 Apr 2014 | Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30 | Pfizer Us Pharmaceutical Group | Drug | Class II | 1 |
| 16 Apr 2014 | Botanos Los 3 Chavos Mango Enchilado Net Wt. 1 1/2 OZ. (42 g) Oaxaca Mexican Products 100 8th Street, Passaic, NJ 07055 (68533) | Oaxaca Mexican Products | Food | Class II | 1 |
| 14 Apr 2014 | Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures. | Terumo Cardiovascular Systems Corporation | Device | Class II | 3 |
| 10 Apr 2014 | Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC… | Bausch & Lomb, Inc. | Drug | Class II | 2 |
| 10 Apr 2014 | Chocolate Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206. | Koogee-Queen Anne, LLC | Food | Class II | 78 |
| 9 Apr 2014 | Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40 | Caraco Pharmaceutical Laboratories, Ltd. | Drug | Class II | 1 |
| 7 Apr 2014 | Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) | Western / Scott Fetzer Company | Device | Class II | 1 |
| 7 Apr 2014 | Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum. | JAS Diagnostics Inc. | Device | Class II | 1 |
| 4 Apr 2014 | Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262. | Steris Corporation | Device | Class II | 1 |
| 2 Apr 2014 | Ah! Laska Organic Cocoa Non Dairy Chocolate Mix; Low Fat, Vegan, USDA Organic; Net Wt. 12 oz. (340 g); UPC 7-60519-10028-7; Ingredient: Organic cane sugar, organic cocoa powder (non-alkaline) organic, rice syrup solids, xanthan gum (a natural thickener) carrageenan (a natural seaweed extract emulsifier),… (67911) | Koru Pacific Packaging, Inc. | Food | Class II | 1 |
| 1 Apr 2014 | Just Great Stuff Chocolate Dream Greens, 42 g bar, The bars are individually wrapped and packed in a display containing 12 bars. The displays are shrink wrapped. | Betty Lou's, Inc. | Food | Class II | 1 |
| 1 Apr 2014 | YES Raspberry Lemonade Sorbetto | Dolci Gelati LLC. | Food | Class III | 6 |
| 31 Mar 2014 | Lao Thai Nam Number One Sompa Salted Fish, Net Wt 7 oz. (198 g), Produced by Lao Thai Nam, 4444 W. Illinois Ave., Ste 400a, Dallas, TX 75211, UPC 8 84332 00019 4 (67864) | Lao Thai Nam Corporation | Food | Class II | 1 |
| 28 Mar 2014 | Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures. (68552) | RGI Medical Manufacturing, Inc. | Device | Class II | 1 |
| 28 Mar 2014 | Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured for United Therapeutics Corporation, Triangle Park, NC 27709 | United Therapeutics Corp. | Drug | Class II | 1 |
| 27 Mar 2014 | There are 2 different labels for this same product with the same UPC. Label #1 Individual Bars: 100% natural Zing Complete Nutrition, DARK CHOCOLATE HAZELNUT, Gluten, Soy & Dairy Free, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Label #1 Display Carton: Zing Complete Nutrition, Gluten, Soy… | NW Nutritional Foods LLC | Food | Class II | 4 |
| 21 Mar 2014 | LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view. (68259) | LAP of America Laser Applications, LLC | Device | Class II | 1 |
| 21 Mar 2014 | Amerigel Wound Dressing 1 oz. tube | Kova Laboratories, Inc. | Device | Class II | 2 |
| 20 Mar 2014 | Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or long-term ultra-low and storage and transport of biological specimens. (68333) | Global Cooling Inc | Device | Class II | 1 |
| 17 Mar 2014 | SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part number in the kit is P17085. . The… | Individual firm, name withheld | Device | Class II | 5 |
| 15 Mar 2014 | The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is… (67715) | Individual firm, name withheld | Device | Class II | 1 |
| 15 Mar 2014 | The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. (67713) | Individual firm, name withheld | Device | Class II | 1 |
| 15 Mar 2014 | Fresh Wild Gulf Amberjack (Whole, Fillet and Portion) (67874) | Whole Foods Market South Seafood Distribution | Food | Class II | 1 |
| 10 Mar 2014 | CTF Brand Tapioca Pearl Net Wt: 14 oz. (400G.) Exporter: Combine Thai Foods Co., Ltd. 359/716-17 Spot Chalaem Nimit, Chalaem Nimit Rd. (Pradu 1) Bangkro, Bangkholaem, Bangkok 10120 Thailand Product of Thailand UPC 8851381560506 (68571) | New B.C.N. Trading Inc | Food | Class II | 1 |
| 7 Mar 2014 | NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement. | Exactech, Inc. | Device | Class II | 1 |
| 20 Feb 2014 | Jardines 7J Queso Amarillo (Item#50100) ; label: Jardine's 7J Ranch Queso Amarillo Cheese Dip; Mild; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A. | Jardine Foods Inc | Food | Class II | 5 |
| 13 Feb 2014 | BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53. (68304) | Healix Infusion Therapy, Inc. | Drug | Class II | 1 |
| 6 Feb 2014 | Oaxaca brand of Anelina in 1/2 oz plastic bags with paper label reading in part: "Oaxaca Mexican Products 100 8th Street Passaic New Jersey 07055 UPC 807310007466 ***" (68534) | Oaxaca Mexican Products | Food | Class II | 1 |
| 3 Feb 2014 | Humei Foods DRIED LILY, Net Wt. 340 g 12 oz +- 5 g -- PRODUCT OF CHINA --- Firms on label: Shanghai Dingmei International Trade Co., LTD, Add: Room 516B, No. 1218, Walma Road, Shanghai, China 200011 Tel: 86 21 33761911 Fax: 86 21 33761933 -- Shanghai Huipu Food Co., LTD, Add: No. 4545, Daye Highway, Fengxian,… (67425) | Humei Trading Inc. | Food | Class I | 1 |
| 31 Jan 2014 | GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. | Hospira Inc. | Device | Class II | 1 |
| 19 Dec 2013 | Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 2 Dec 2013 | MAS Omni Immune Controls | Microgenics Corporation | Device | Class III | 2 |
| 15 Nov 2013 | Physique Enhancing Science ALPHAMINE, Powerful Thermogenic Powder, DIETARY SUPPLEMENT Net Wt. 8.9 oz (252 g). Raspberry Lemonade and Fruit Punch flavors. | Individual firm, name withheld | Food | Class II | 2 |
| 8 Nov 2013 | UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories. | Beckman Coulter Inc. | Device | Class II | 4 |
| 17 Oct 2013 | Pran Spice Powder Turmeric , 14.10 oz. (400g) clear plastic laminated pouch, UPC 8 3173000502 3 (66523) | Fahman Enterprises, Inc | Food | Class I | 1 |
| 11 Oct 2013 | PRAN TURMERIC POWDER 400 GM plastic bag (66486) | Best Value Inc | Food | Class I | 1 |
| 8 Oct 2013 | PRAN brand Spice Powder TURMERIC, Net Wt. 8.82 oz./250g, UPC 8 31730 00551 --- PRODUCT OF BANGLADESH -- Manufactured by/Fabricado por: PRAN AGRO LTD, PRAN-RFL Center, 105 Middle Badda, Dhaka-1212, Bangladesh --- This product is packed in a clear plastic jar with a yellow plastic lid. (66455) | Asia Cash & Carry Inc. | Food | Class I | 1 |
| 3 Oct 2013 | PRAN brand Spice Powder TURMERIC, Net Wt. 14.1 oz./400g, UPC 8 46656 00209 4, and Net Wt. 8.82 oz./250g, UPC 8 31730 00551 --- PRODUCT OF BANGLADESH -- Manufactured by/Fabricado por: PRAN AGRO LTD, PRAN-RFL Center, 105 Middle Badda, Dhaka-1212, Bangladesh --- This product is packed in clear plastic jars with yellow… (66440) | Ontime Distribution Inc. | Food | Class I | 1 |
| 19 Sep 2013 | ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3 | Ferring Pharmaceuticals Inc | Drug | Class III | 1 |
| 17 Sep 2013 | Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 28 Aug 2013 | Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 20 Aug 2013 | Ducal Brand Prepared Sauce Queso/Cheese, UPC 088313-08328-6, Net Wt 4 oz, Product of Guatemala, C.A. Central American product made with quality by: Industrias Alimenticias Kern's Y/Cia, S.C.A., Km. 6 1/2 Carretera al Atlantico. Reg. D.G.R.V.C.S.D.R.C.A. B 658 The product was shipped in cases each of which included 4… (66358) | Industrias Alimenticias Kern's y Cia. S.C.A. | Food | Class II | 1 |
| 16 Jul 2013 | Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the… | Zoll Circulation, Inc. | Device | Class III | 1 |
| 8 Jul 2013 | Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 25 Jun 2013 | ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 13 Jun 2013 | ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13. | CareFusion 213, LLC | Drug | Class II | 1 |
| 24 Jan 2013 | HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer. | Cenorin, LLC | Device | Class II | 1 |
| 28 Nov 2012 | ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems | The Anspach Effort, Inc. | Device | Class II | 45 |
| 11 Oct 2012 | Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 10 May 2012 | Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter. | Perouse Medical | Device | Class II | 1 |
| 7 May 2012 | Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products (68570) | MTI Precision Products LLC. | Device | Class II | 1 |
| 27 Apr 2012 | Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086 | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 27 Sep 2011 | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90 | Shamrock Medical Solutions Group LLC | Drug | Class I | 6 |
| 17 Aug 2011 | ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 (25.7406), CS400-B (76.7801), CS408N-B (76.8001), CS3000-O (76.7808), CS400-O (76.7802), CS408N-O (76.8002), CS3000-G (76.7809), CS400-G (76.7803), CS408N-G (76.8004), CS3000-P (76.7810),… (68591) | Codan Us Corporation | Device | Class II | 1 |
| 11 Jan 2011 | SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter (68456) | SteriGear, LLC | Device | Class II | 1 |
| 25 Jan 2009 | IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications. (68447) | Zynex Medical, Inc. | Device | Class II | 1 |