| 9 May 2016 | Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal… | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 4 May 2016 | Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401 3.5 mm Cortical Screw SelfTapping, 30 mm Length… | Zimmer Manufacturing B.V. | Device | Class II | 12 |
| 24 Apr 2016 | Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D… | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 24 Apr 2016 | Gold Emblem Abound Organic Spiced Herbal Tea, 20 TEA BAGS, NET WT 1.41 OZ (40g) (73950) | CVS Health | Food | Class II | 1 |
| 22 Apr 2016 | Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0 | A-S Medication Solutions LLC. | Drug | Class III | 1 |
| 22 Apr 2016 | TRADER JOE'S Apple Cider, NOT FROM CONCENTRATE SHAKE WELL NO PRESERVATIVES 100% JUICE PASTEURIZED. PERISHABLE, KEEP REFRIGERATED. NET 64 FL OZ (2 QT) 1.89 L. UPC: 0016 4580. (73933) | Individual firm, name withheld | Food | Class II | 1 |
| 22 Apr 2016 | Organic Green Tea Hojicha, Net 16 kgs, (bulk product 16 kg boxes with inner liner) (73939) | Individual firm, name withheld | Food | Class II | 1 |
| 22 Apr 2016 | Organic Ginger Root Tea Bag Cut (TBC), 25 kgs | Individual firm, name withheld | Food | Class II | 3 |
| 21 Apr 2016 | GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures.… | Baxter Healthcare Corp. | Device | Class II | 5 |
| 20 Apr 2016 | GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications | GE Medical Systems, LLC | Device | Class II | 1 |
| 20 Apr 2016 | Thin Egg Noodle (Mi Trung Ga), 5lbs, 8 units/case (73914) | Sincere Orient Commercial Foods Corp. | Food | Class II | 1 |
| 19 Apr 2016 | Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters. | Elekta, Inc. | Device | Class II | 1 |
| 18 Apr 2016 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771 | VistaPharm, Inc. | Drug | Class II | 1 |
| 18 Apr 2016 | Royal Snacks Jalapeno Pistachio Royal Size (73897) | Royal Snacks Inc | Food | Class II | 1 |
| 15 Apr 2016 | Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH… | Covidien LLC | Device | Class II | 2 |
| 15 Apr 2016 | CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester,… | Carestream Health Inc | Device | Class II | 2 |
| 15 Apr 2016 | MegaFood Multi for Women 40+, Multivitamin & Mineral Dietary Supplement packaged in glass bottles UPC:5149410321 -Packaged 60 tablets; UPC:5149410322 -Packaged 120 tablets (73843) | FoodState, Inc | Food | Class II | 1 |
| 15 Apr 2016 | Passion 4 Life 30 FL oz. Bottle (73888) | Health 4 Life, LLC | Food | Class I | 1 |
| 15 Apr 2016 | COMMERCIAL WHEAT GERM 274000, 50.00 lbs. (22.68 kg); UPC Code: 0-26938-46535-3 (73934) | UNFI | Food | Class II | 1 |
| 14 Apr 2016 | LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery. | Alcon Research, Ltd. | Device | Class II | 1 |
| 14 Apr 2016 | Syngo Dynamics; Kinetdx Picture Archiving and Communications System | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 14 Apr 2016 | HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 14 Apr 2016 | Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This… | Biosense Webster, Inc. | Device | Class II | 2 |
| 14 Apr 2016 | NORVEN herring in oil, Net Wt. 17.6 oz. (500g), UPC barcode 856687004196, and Net Wt. 10.6 oz. (300g), UPC barcode 856687004189 -- Product of Ukraine -- Distributed by: OLMA-XXI Inc. 204 28th Street, Brooklyn, NY 11232 (73864) | OLMA-XXI INC. | Food | Class I | 1 |
| 13 Apr 2016 | Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack powers the monitor when AC power is not available or when monitoring is required during… | Medtronic | Device | Class I | 1 |
| 13 Apr 2016 | MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 12 Apr 2016 | Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960 | Stanmore Implants Worldwide Ltd. | Device | Class II | 1 |
| 12 Apr 2016 | CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle,… | Stryker Corporation | Device | Class II | 2 |
| 12 Apr 2016 | Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the… | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 12 Apr 2016 | Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87 | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 12 Apr 2016 | SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01. | Mckesson Packaging Services | Drug | Class III | 1 |
| 11 Apr 2016 | Sliced Peaches (In Light Syrup), Net Wt. 8oz (227g), Bottle Label UPC 0-49022-80894-2, Case UPC 100-49022-80894-9 | Milky Way Intl Trading Corp | Food | Class II | 2 |
| 11 Apr 2016 | Colby Jack cheese, 8 oz. and 16 oz, Vacuumed plastic pouches (73739) | Msu Dept Of Fd Sci Dairy Plant | Food | Class III | 1 |
| 11 Apr 2016 | Organic Chamomile Tea Bag Cut (TBC) bulk sold in original cases (25kg bags), Bulk product 25 kg craft paper bags "L 0609-13681-238641-01 ORGANIC CHAMOMILE TBC CERTIFIED ORGANIC MATRICARIA CHAMOMILLA 25KG NET ORIGIN: COSOVO WORLEE HAMBURG" (73824) | Individual firm, name withheld | Food | Class II | 1 |
| 8 Apr 2016 | Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery. | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution | Device | Class II | 1 |
| 8 Apr 2016 | ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 8 Apr 2016 | Alfalfa Sprout Product***Germinados Campo Verde***San Sebastian, Puerto Rico (73836) | Individual firm, name withheld | Food | Class I | 1 |
| 8 Apr 2016 | Organic Lemon Myrtle packed in a 12.5kg plastic bag inside of a cardboard box. (73844) | Dmh Ingredients Inc | Food | Class II | 1 |
| 8 Apr 2016 | Classic Creme Cookies, Net wt. 12 oz cartons, 6 cartons per case. Manufactured for Back To Nature Foods Co., LLC (73800) | Back To Nature Foods, Llc | Food | Class I | 1 |
| 7 Apr 2016 | Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% /… | Akorn, Inc. | Drug | Class II | 1 |
| 7 Apr 2016 | Taste of Inspirations Edamame Rangoon 9 oz . carton, frozen UPC: 072543998453 (73798) | Progressive Gourmet Inc. | Food | Class I | 1 |
| 7 Apr 2016 | Michel et Augustin brand Petites baguettes butter cookies Dark Chocolate with a pinch of salt, NET WT. 1.58 oz (45g), UPC 81266802016, Product of the Netherlands -- Manufactured for Michel et Augustin SA, 151 rue de Billancourt (Grand Paris) France --- The label states "May contain tree nuts and peanuts." but no… (73784) | Michel et Augustin Inc | Food | Class II | 1 |
| 7 Apr 2016 | Classic Pesto Sauce (with a twist), net wt. 4 oz. (113 g). Product is packaged in a round Styrofoam containers with translucent plastic lid. The UPC is 8 20103 77214 3. The product is labeled in parts: "***Classic Pesto (with a twist)***INGREDIENTS: Olive Oil, Brazil nuts, Garlic, Parmesan cheese, Basil, Onion***Made… | Individual firm, name withheld | Food | Class II | 2 |
| 6 Apr 2016 | Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and… (73884) | Nuvectra | Device | Class II | 1 |
| 6 Apr 2016 | Granna's 808 French Toast, Diced Potatoes, Mandarin Oranges in three compartment black, plastic tray, stored frozen (73782) | Granna's, LLC | Food | Class I | 1 |
| 5 Apr 2016 | Liposomal Magnesium Nutritional Supplement. 6 FL. OZ (180 ml) The product is packaged in a six ounce, plastic, Royalty Bottle, with a 24mm vented flip top lid. item number: DES004Z. Sold under brands DESBIO and Seeking Health (73814) | Empirical Laboratories, Incorporated | Food | Class II | 1 |
| 5 Apr 2016 | Cha-Ching Original Potato Chips Net Wt 10 OZ.; Distributed by OZA Brands, LLC, Salisbury, NC 28147 (73877) | Wise Foods Inc | Food | Class II | 1 |
| 4 Apr 2016 | 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 4 Apr 2016 | Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175 | Stryker Sustainability Solutions | Device | Class II | 2 |
| 4 Apr 2016 | BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430. | Keystone Laboratories Inc | Drug | Class II | 1 |
| 4 Apr 2016 | La Fiesta Bean Salad (2/5 LB Tubs) Made By Fresh Creative Foods Moore, OK 73160 UPC 013454371763 packaged in white plastic tub with lid (73762) | Vaughan Foods | Food | Class II | 1 |
| 2 Apr 2016 | Dunkin Donuts Brand Italian Sub, Net Wt 7.7 oz packaged in Bag, Clear View | Flying Food Group LLC | Food | Class II | 6 |
| 1 Apr 2016 | Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits. | Applied Medical Resources Corp | Device | Class II | 1 |
| 1 Apr 2016 | Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings. | Medtronic | Device | Class II | 2 |
| 1 Apr 2016 | SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 1 Apr 2016 | Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 1 Apr 2016 | Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center… | B Braun Medical Inc | Device | Class I | 6 |
| 1 Apr 2016 | Sugarfina Chocolate Malt Balls UPC Code 840278113565 SKU K1159 | Sugarfina, LLC | Food | Class I | 1 |
| 1 Apr 2016 | Roland (R) Fire Roasted Red Pepper Strips, NET WT. 5 LB. 8 OZ. (2.5 kg), UPC 10041224456287 (carton) and 04122456280 (can), PRODUCT OF PERU -- Packed Exclusively For: ROLAND FOODS, LLC, New York, NY 10070 | Roland Foods, LLC. | Food | Class II | 1 |
| 1 Apr 2016 | Emerald 100 Calorie Packs of Cashew Halves & Pieces, roasted and salted. 7 pack/ 0.62 oz. each (17.5 g). Ingredients: Cashews, Vegetable Oil/Safflower, Sunflower and/or Canola Oil, Salt, Rosemary extract (to preserve freshness: Retail Carton UPC: 0 10300 33324 1; Inner Package UPC: 0 10300 33399 9; Distributed by:… | Diamond Foods, Inc. | Food | Class II | 1 |
| 31 Mar 2016 | Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. | St Jude Medical Inc. | Device | Class II | 1 |
| 31 Mar 2016 | BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used… | Becton, Dickinson and Company, BD Biosciences | Device | Class II | 1 |
| 31 Mar 2016 | X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography | Shimadzu Medical Systems | Device | Class II | 1 |
| 31 Mar 2016 | CF InPlex ASR Card; Catalog Number: 95-0501. | Hologic, Inc | Device | Class II | 2 |
| 31 Mar 2016 | Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network for viewing by the physician.… | Medtronic Inc., Cardiac Rhythm and Heart Failure | Device | Class II | 1 |
| 31 Mar 2016 | ALFALFA SEED, NET WT. 50 LB. International Specialty Supply LLC, Cookeville, TN | International Sprout Holding Inc. | Food | Class I | 1 |
| 30 Mar 2016 | Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use | Teleflex Medical | Device | Class II | 1 |
| 30 Mar 2016 | ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 30 Mar 2016 | reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis,… (73779) | LED Technologies, LLC | Device | Class II | 1 |
| 30 Mar 2016 | Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30 (73822) | Individual firm, name withheld | Drug | Class II | 1 |
| 30 Mar 2016 | Manischewitz Pistachio Orange Macaroons 10 oz. Distributed by: The Manischewitz Company Newark, NJ 07105 Product of USA UPC 0-7270000119-6 | R.A.B. Food Group LLC | Food | Class III | 1 |
| 29 Mar 2016 | ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only. | ev3, Inc. | Device | Class II | 1 |
| 28 Mar 2016 | PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High Flow Insufflator is a device that serves to… (73674) | Individual firm, name withheld | Device | Class II | 1 |
| 28 Mar 2016 | ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies. | The Anspach Effort, Inc. | Device | Class II | 2 |
| 28 Mar 2016 | Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization… | Becton Dickinson & Co. | Device | Class II | 1 |
| 28 Mar 2016 | Meijer Plain Knot Rolls, 8 ct., Net Wt. 10 oz.; 12/case, 9.4 lbs/case | R.W. Bakers Co. Inc. | Food | Class II | 2 |
| 25 Mar 2016 | NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. NeuroBlate System SideFire Select Directional Laser Probes are part of the NeuroBlate System. The Monteris Medical NeuroBlate System is indicated for… | Monteris Medical Corp | Device | Class I | 1 |
| 25 Mar 2016 | EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 25 Mar 2016 | Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray… | Hansen Medical Inc | Device | Class II | 1 |
| 25 Mar 2016 | AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only. | Ab Sciex | Device | Class II | 1 |
| 25 Mar 2016 | Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch. | Bryant Ranch Prepack Inc. | Drug | Class III | 1 |
| 25 Mar 2016 | Welltop Fried Dace, Net Weight 184g, Product of China, packed for Hui Zhou Welltop Foods Import and Export Co. Ltd. Importer: Guong Aik Sdn. Bhd No. 13 Long Bridge Road, PO Box 1056, 96008, Sibu, Sarawak, East Malaysia, Importer Strong America Ltd, 2-39 54th Ave., Long Island City, NY (73648) | Strong America Limited | Food | Class III | 1 |
| 24 Mar 2016 | NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. | Philips and Neusoft Medical Systems Co., Ltd. | Device | Class II | 1 |
| 24 Mar 2016 | Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. | CareFusion 303, Inc. | Device | Class II | 1 |
| 23 Mar 2016 | Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5. | Hospira Inc. | Drug | Class III | 1 |
| 23 Mar 2016 | Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03 (73571) | TMIG Inc | Drug | Class II | 1 |
| 21 Mar 2016 | Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus. | Hardy Diagnostics | Device | Class II | 1 |
| 18 Mar 2016 | Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an… | Boston Scientific Corporation | Device | Class II | 1 |
| 18 Mar 2016 | 1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number 381700 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer catalog number 381720 | Becton Dickinson & Company | Device | Class II | 1 |
| 18 Mar 2016 | Andrographis extract 400 mg packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering. | NOW Foods | Food | Class II | 5 |
| 17 Mar 2016 | enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 17 Mar 2016 | Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 16 |
| 17 Mar 2016 | Bliss French Vanilla Ice Cream 64oz Product Code: 51051 | Bliss Bros Dairy, Inc. | Food | Class II | 22 |
| 16 Mar 2016 | DandleLION Kisses, 24% Sterile Organic Sucrose In Purified Water, 2 ml polyethylene vial. For oral use Part Number D 12442 C384 (73637) | Tarry Medical Products, Inc. | Food | Class II | 1 |
| 16 Mar 2016 | Cold smoked white fish, vacuum packaged, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009 | North Fish Usa | Food | Class II | 11 |
| 15 Mar 2016 | GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult). | GE Medical Systems, LLC | Device | Class II | 1 |
| 15 Mar 2016 | Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02 | Hospira Inc. | Drug | Class III | 1 |
| 15 Mar 2016 | Nuwati Herbals SeeLessO'Me Diet and Weight Management Tea packaged in two different size amber glass jars with Net Wt 3 oz. or Net Wt 6 oz. The responsible name on the label is Nuwati Herbals Inc., House Springs, MO. (73554) | Nuwati Herbals Inc | Food | Class II | 1 |
| 11 Mar 2016 | Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators,… (73581) | RESEARCH INSTRUMENTS LTD - SITE B | Device | Class II | 1 |
| 11 Mar 2016 | Imperial Choice Mandarin Oranges Broken Segments in Light Syrup; Net WT. 11 oz.; Imported by Acme Food Sales, Seattle, WA 98108; Product of China; 4200/01029; PRO: DEC 21, 2013; Best By: Dec 21, 2016 (73702) | Greater Pittsburgh Community Food Bank | Food | Class III | 1 |
| 10 Mar 2016 | Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL. (73650) | Jas Diagnostics/Drew Scientific | Device | Class II | 1 |
| 10 Mar 2016 | eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff. (73673) | Individual firm, name withheld | Device | Class II | 1 |
| 10 Mar 2016 | Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg. | Ferno-Washington Inc | Device | Class II | 2 |
| 9 Mar 2016 | Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor. | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 9 Mar 2016 | Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and… | Hamilton Medical, Inc. | Device | Class II | 1 |
| 9 Mar 2016 | Nature's Eats Natural Pistachios NET WT 8 OZ (227g) packaged in clear cello bag and Bulk RAW PISTACHIO - 25 LBS and Bulk RAW PISTACHIO - 5 LBS packaged in corrugated box | Texas Star Nut and Food Co., Inc. | Food | Class I | 6 |
| 9 Mar 2016 | Roasted No Salt Inshell Pistachios: Packaged under brand name of Wonderful. Packed in 16 oz., 8 oz., 200 grams and 225 grams bags. UPC - 16 oz: 014113910064 UPC - 8 oz:.014113910187 UPC - 200 grams: 014113913652 UPC - 225 grams: 014113912532 | Wonderful Pistachios & Almonds, LLC. | Food | Class I | 8 |
| 8 Mar 2016 | Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 8 Mar 2016 | The Super Elixir By WelleCo Australia Alkalising Greens 150g/5.3 oz net, 300g/10.6 oz net Fine Powder welleco.com (73619) | Welle Pty Ltd | Food | Class I | 1 |
| 7 Mar 2016 | ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 7 Mar 2016 | Phosphoric Acid, 75% and 85% Food Grade (Brand Name PRAYPHOS PPA 75% FG and PRAYPHOS PPA 85% FG) (73458) | Prayon Inc. | Food | Class III | 1 |
| 3 Mar 2016 | Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 3 Mar 2016 | Duncan Hines Signature Swiss Chocolate Cake Mix, 16.5 oz. cartons, Distributed by: Pinnacle Foods, Cherry Hill, New Jersey USA, UPC 6 44209 41120 7 | Pinnacle Foods, LLC | Food | Class II | 2 |
| 2 Mar 2016 | Cheese & Fruit Bistro Box (Item #11015085), Starbucks brand. Product is packaged in plastic clamshell, net wt. 5.3 oz. The UPC is 7 62111 88146 5. (73449) | Individual firm, name withheld | Food | Class II | 1 |
| 29 Feb 2016 | col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011. | Allegiant Health | Drug | Class III | 1 |
| 24 Feb 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S.… | Biomerieux Inc | Device | Class I | 9 |
| 24 Feb 2016 | VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The… | Biomerieux Inc | Device | Class II | 1 |
| 24 Feb 2016 | Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP¿ 4500MD LC/MS/MS System,… | Ab Sciex | Device | Class II | 1 |
| 23 Feb 2016 | RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery. | Mako Surgical Corporation | Device | Class II | 1 |
| 23 Feb 2016 | Macadamia Diced Nuts packaged under the following brands: 1) Shurfine, Item no. 86635, 5 OZ (142 g) plastic bags, packed 12 bags per case, UPC 0 15400 86635 4. Distributed by Western Family Foods, Inc., Portland OR. 2) Western Family, 5 OZ (142 g) plastic bags, packed 12 per case, UPC 0 15400 16635 5. Distributed by… | Marathon Ventures Inc | Food | Class I | 1 |
| 22 Feb 2016 | Bissinger's Milk Chocolate Eggs packaged in 6.5 oz (UPC 846107009382) Item: #11108 or 1 lb. (UPC 846107003458) Item: # 111049 plastic bags. Bissinger's Handcrafted Chocolatier, St. Louis, MO. (73345) | Karl Bissinger, LLC | Food | Class III | 1 |
| 19 Feb 2016 | ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is… | Horiba Instruments Inc | Device | Class II | 2 |
| 18 Feb 2016 | The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management. (73486) | Livongo Health | Device | Class II | 1 |
| 17 Feb 2016 | TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure. | Applied Medical Technology Inc | Device | Class II | 4 |
| 16 Feb 2016 | Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 16 Feb 2016 | Automated peritoneal dialysis (APD) cycler | Baxter Healthcare Corp. | Device | Class II | 1 |
| 16 Feb 2016 | Diced Red Potatoes, hand labeled: "Potato, Red Dice, 40# 3/4 large" (73644) | Specialty Produce Corporation | Food | Class II | 1 |
| 15 Feb 2016 | TRIGAL*** Empanadillas Sabor a Carne (meat flavored turnovers)***Peso neto 3 lbs (Net Weight 3 pounds)*** Pqte. de 12 (12 units package)***Pastry Foods Inc. Rio Piedras PR | Pastry Food Products Inc. | Food | Class II | 3 |
| 12 Feb 2016 | Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93 | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 11 Feb 2016 | Organic traditions SPROUTED FLAX SEED POWDER, NET WT. 8 oz/227g, UPC 854260006261 --- The product is packed in a sealed flexible plastic bag. | Health Matters America, Inc. | Food | Class I | 2 |
| 9 Feb 2016 | Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 8 Feb 2016 | Bunge Soy Clear Fry Oil OU, 35 lb., Manufactured by: Bunge Oils, Inc. Kearny, NJ 07032, UPC 00078684692026 | Bunge Oil North America Inc. | Food | Class II | 24 |
| 29 Jan 2016 | Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container. | Valeant Pharmacueticals International | Device | Class II | 1 |
| 29 Jan 2016 | Trinity Acetabular System Product Usage - Total Hip Replacement. | Corin USA Limited | Device | Class II | 3 |
| 29 Jan 2016 | Raw Meal Organic Vanilla Powder; Organic Shake and Meal Replacement; 949 g, 475 g, and 10-ct tray (68 g each). Packaged in plastic bottle with colored label. | Garden Of Life Llc | Food | Class I | 4 |
| 22 Jan 2016 | 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. | 3M Company - Health Care Business | Device | Class II | 1 |
| 15 Jan 2016 | Fresh Express, Family Size Baby Spinach, Net Wt. 12oz in clear flexible plastic bags. | Fresh Express Incorporated | Food | Class I | 1 |
| 14 Jan 2016 | Suan's Scotch Bonnet Pepper Relish 9.8 oz. packaged in a glass jar with a metal lid. (73068) | S & S Foods, Inc. | Food | Class III | 1 |
| 10 Dec 2015 | Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0). (73578) | Ascom US, INC. | Device | Class II | 1 |
| 25 Nov 2015 | MAKOplasty Hip Array Kit Laminate 150230 | Mako Surgical Corporation | Device | Class II | 1 |
| 18 Nov 2015 | TCM CombiM Modules 903-111 | Radiometer America Inc | Device | Class II | 1 |
| 17 Nov 2015 | Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971). | Lumenis Ltd | Device | Class II | 1 |
| 17 Nov 2015 | Bertagni fresh Sweet Butternut Squash Ravioli, packaged in a paper tray inside a plastic bag and wrapped around with paper band, net weight 8.8 oz., UPC 8001020110139. | Bertagni 1882 | Food | Class I | 2 |
| 16 Nov 2015 | NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation | Novarad Corporation | Device | Class II | 1 |
| 9 Nov 2015 | Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature | C.R. Bard, Inc. | Device | Class II | 1 |
| 16 Oct 2015 | Kroger Raw #4 Macadamia Nuts. UPC 2 04192 51053 2 Dist. by the Kroger Company Cincinnati, Ohio 45202 | The Kroger Co | Food | Class I | 1 |
| 15 Oct 2015 | Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268 | Individual firm, name withheld | Drug | Class II | 10 |
| 11 Sep 2015 | Iowa Select Herbs LLC, Acerola Berry (Malpighia), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402 | Iowa Select Herbs LLC | Food | Class III | 104 |
| 8 Sep 2015 | Family Gourmet Long Grain Enriched White Rice, 32 oz. (2 lb.) plastic bag (SKU: 1218898) | Individual firm, name withheld | Food | Class II | 2 |
| 5 Sep 2015 | ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 11 Aug 2015 | Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries. | Alcon Research, Ltd. | Device | Class II | 3 |
| 3 Aug 2015 | Concentrated coffee packed in 1/2 gallon or 1 gallon hermetically sealed Scholle or Liquibag. (72474) | Liquid Coffee Inc | Food | Class II | 1 |
| 2 Jul 2015 | Spirit One A-C Powered Hospital Bed | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 2 Jul 2015 | Spirit One A-C Powered Hospital Bed | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 2 May 2015 | NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) | Neusoft Medical Systems Co., Ltd. | Device | Class II | 1 |
| 26 Mar 2015 | Diamedix Is-CMV IgG Test Kit | Diamedix Corporation | Device | Class II | 1 |
| 2 Feb 2015 | Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable… (73873) | Bradshaw Medical Inc. | Device | Class II | 1 |
| 20 Oct 2014 | Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection. | Diamedix Corporation | Device | Class II | 3 |
| 6 Oct 2014 | INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts. | Alcon Research, Ltd. | Device | Class II | 1 |
| 26 Jul 2013 | Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position (73657) | Atlas Spine, Inc. | Device | Class II | 1 |