| 10 Feb 2017 | StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411. (76448) | Individual firm, name withheld | Device | Class II | 1 |
| 8 Feb 2017 | Crystal Geyser Sparkling Mineral Water, Original; 18 oz. (53 ml) plastic bottles sold in 28 pack wrapped tray. UPC codes: Bottle Label 6 54871 18001 1 Case 6 54871 18249 7 (76455) | Crystal Geyser Water Company | Food | Class II | 1 |
| 2 Feb 2017 | Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 30 Jan 2017 | Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4 | Actavis Inc | Drug | Class II | 1 |
| 30 Jan 2017 | Burts British Hand Cooked Potato Chips Sea Salt & Malted Vinegar 150gx10 and 40gx20 (76350) | Bwi Inc | Food | Class II | 1 |
| 25 Jan 2017 | ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 25 Jan 2017 | MARICH Premium Chocolates; Chocolate Caramel Heart; Our delicious caramel hearts in rich milk and dark chocolate; Net Wt 4.25 oz. (120g) UPC 797817-44440-9 (76331) | Marich Confectionery Company, Inc. | Food | Class II | 1 |
| 24 Jan 2017 | Circle U Foods, Inc. Product Code: 1009008 NPP/Connie's Microwave Pizza Sauce Seasoning 25.00 Lbs. | Circle U Foods, Inc | Food | Class II | 5 |
| 20 Jan 2017 | Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps. and/or… | GE Healthcare, LLC | Device | Class II | 1 |
| 20 Jan 2017 | Integra Cadence Total Ankle System | Integra LifeSciences Corp. | Device | Class II | 1 |
| 20 Jan 2017 | Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008 | Atrium Medical Corporation | Device | Class II | 2 |
| 20 Jan 2017 | Pizza Hut Creamy Alfredo sauce, case size 40 lbs. 8 bags per case. Bags are each 80 oz (5 lbs) of sauce (76320) | Yum Retaurants International | Food | Class III | 1 |
| 20 Jan 2017 | NOW¿ Multi-Food 1 Tablets, One Tablet Daily, 90 tablets, A Dietary Supplement | NOW Foods | Food | Class III | 1 |
| 20 Jan 2017 | Fresh Foods Market Delicatessen Rotini Pasta Salad; Net Wt. 10 oz . (283g) Clamshell package. UPC Code: WO2017019 Perishable; Keep Refrigerated; Distributed by The Kroger Col., Cincinnati, OH (76296) | Taylor Farms Pacific, Inc. | Food | Class II | 1 |
| 19 Jan 2017 | 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and… | Acumed LLC | Device | Class II | 1 |
| 18 Jan 2017 | BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens | Argon Medical Devices, Inc | Device | Class II | 3 |
| 18 Jan 2017 | Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771. | VistaPharm, Inc. | Drug | Class II | 1 |
| 18 Jan 2017 | Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771 | VistaPharm, Inc. | Drug | Class II | 11 |
| 18 Jan 2017 | FRONT: Stauffer's Animal Crackers Original; Net Wt. 32 OZ.; BACK: (best by date): 07SEP17; (bag lot numbers) LC120716 or LD120716; Stauffer Biscuit Co., York, PA 17403. | D. F. Stauffer Biscuit Co, Inc. | Food | Class I | 1 |
| 17 Jan 2017 | Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the… (76249) | Individual firm, name withheld | Device | Class II | 1 |
| 16 Jan 2017 | BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium… | Becton Dickinson & Company | Device | Class II | 1 |
| 16 Jan 2017 | LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and… | Physio-Control, Inc. | Device | Class II | 2 |
| 16 Jan 2017 | Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and (b)120 g (50222-501-66) tubes, Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054. | LEO PHARMA INC | Drug | Class III | 1 |
| 16 Jan 2017 | DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56 | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 13 Jan 2017 | InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. The system has a modular design to allow the device to be assembled within the disc… (76275) | Vertebral Technologies, Inc. | Device | Class II | 1 |
| 13 Jan 2017 | PICTSWEET(R) FARMS, Southern Classics, Crunchy Breaded Okra, NET WT 12 OZ (340g), UPC 7056098377 | The Pictsweet Company | Food | Class II | 1 |
| 13 Jan 2017 | Frozen Ground Tuna. Product is labeled in part: "PIER FISH CO. 68 CONWAY ST NEW BEDFORD, MA 02740 COLUMBUS FISH & SFD TUNA GRIND LOT# 16185 PRODUCT OF : USA HARVESTED: WILD CAUGHT NET WT: 20 LBS (76259) | Pier Fish Company, Inc. | Food | Class II | 1 |
| 12 Jan 2017 | LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older. | Physio-Control, Inc. | Device | Class I | 1 |
| 12 Jan 2017 | Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 | Carestream Health Inc | Device | Class II | 1 |
| 12 Jan 2017 | Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer. | Boston Scientific Corporation | Device | Class II | 1 |
| 12 Jan 2017 | Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles (NDC 62756-519-13) Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat, India. | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 1 |
| 12 Jan 2017 | Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53 | Actavis Inc | Drug | Class III | 1 |
| 12 Jan 2017 | Los Chileros, Basil Pesto, Net Wt. 6 oz. (170g). plastic shell container. Keep Refrigerated (76286) | Los Chileros De Nuevo Mexico, LLC | Food | Class II | 1 |
| 11 Jan 2017 | VIDAS 3 software v. 1.1.4 | BioMerieux SA | Device | Class II | 1 |
| 11 Jan 2017 | Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 11 Jan 2017 | Syngo.plaza, picture archiving and communications system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 11 Jan 2017 | Xambo, 80 boxes of bulk capsules. Each containing 12,053 capsules in each box. | West Coast Laboratories Inc | Food | Class II | 2 |
| 10 Jan 2017 | 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 10 Jan 2017 | LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both… | Encore Medical, Lp | Device | Class II | 1 |
| 10 Jan 2017 | Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants. | Encore Medical, Lp | Device | Class II | 1 |
| 10 Jan 2017 | Snacking Favorites Organic Veggies with Organic Ranch Dip. 16.25 oz. plastic tray (1.02 lb.) UPC barcode: 71651901471 - this is the incorrect barcode that is on the bottom of recalled product. Correct UPC: 716519014765 Incorrect Allergen Statement: Egg. Milk Correct Allergen Statement, Egg, Milk, Soy and Mustard. | Mann Packing Company, Inc. | Food | Class I | 1 |
| 9 Jan 2017 | STERRAD NX Sterilization System, Product Code: 10033, 10033-002 | Advanced Sterilization Products | Device | Class II | 1 |
| 9 Jan 2017 | GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 7 Jan 2017 | Olympus Scientific Solutions Americas Corporation ( OSSA ) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems | Olympus Scientific Solutions Americas | Device | Class II | 1 |
| 6 Jan 2017 | Hitachi Oasis MRI System - C-Spine Coil | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 6 Jan 2017 | Everroast Chicken Caesar Wrap, UPC: 72036-95828, in clear flexible plastic. (76188) | Individual firm, name withheld | Food | Class II | 1 |
| 6 Jan 2017 | DANONE¿ DAIRY DRINK NUT AND CEREAL 7.7 FL OZ (229mL) bottles, UPC 36632 01421 | The Dannon Company, Inc. | Food | Class II | 1 |
| 5 Jan 2017 | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids. | PerkinElmer Life and Analytical Sciences, Wallac, OY | Device | Class II | 2 |
| 5 Jan 2017 | VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 --- Ortho-Clinical Diagnostics Pencoed, CF35… | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 5 Jan 2017 | Dr. Pepper, 2 Liters (2.1 qt) plastic bottles, Bottled under the authority of Dr. Pepper Company, 5301 Legacy Drive, Plano, TX 75024. (76271) | Coca-Cola Consolidated | Food | Class III | 1 |
| 4 Jan 2017 | Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 4 Jan 2017 | Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is… | Baxter Healthcare Corporation | Device | Class II | 2 |
| 4 Jan 2017 | Cappuccino Snack Mix Lot code: 20161027; Best By: 05/25/17 Net Wt: 10 lb (2-5lb bags) (76174) | Dutch Valley Food Distributors Inc. | Food | Class I | 1 |
| 3 Jan 2017 | Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures. | Allen Medical Systems, Inc. | Device | Class II | 1 |
| 3 Jan 2017 | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System | Stryker Leibinger GmbH & Co. KG | Device | Class II | 2 |
| 3 Jan 2017 | Hemp & Grain Co., Organic Pea Protein 80%, Net Weight 44.1 lbs. Paper bags, 36 paper bags/pallet. (76234) | Del Dee Foods Inc. | Food | Class I | 1 |
| 2 Jan 2017 | Whole Foods Market, TART FRESH FRUIT AMERO SHELL LARGE | Whole Foods Market Brand 365, Llc | Food | Class I | 8 |
| 30 Dec 2016 | 34 White Confectionery Coating | Blommer Chocolate Co., Inc. | Food | Class I | 4 |
| 30 Dec 2016 | Kings Pastry Tuxedo Bar Cake (12" x 4"), 1050 g Product Code: 10038 UPC: 685961100381 | Individual firm, name withheld | Food | Class I | 6 |
| 29 Dec 2016 | Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 29 Dec 2016 | Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90 (76120) | Hetero Drugs Ltd. - Unit 1 | Drug | Class III | 1 |
| 29 Dec 2016 | Cashew Curry Tahini, Jem brand, 16 oz glass jar has UPC 8 61437 00036 6. Cashew Curry Tahini, Jem brand, 6 oz glass jar has UPC 8 61437 00035 9. | Jem Raw Chocolate LLC | Food | Class I | 2 |
| 28 Dec 2016 | Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with… | Medtronic Advanced Energy, LLC | Device | Class II | 11 |
| 28 Dec 2016 | Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India | Individual firm, name withheld | Drug | Class II | 4 |
| 28 Dec 2016 | Pittsburgh Spice Co; Buffalo Wing Sausage, 20.25 OZ for 25 #; 1235 Clairhaven St, Pittsburgh, PA 15205 (76117) | PITTSBURGH SPICE & SEASONING CO | Food | Class II | 1 |
| 28 Dec 2016 | Joe Chips Retro Potato Chips Sour Cream & Toasted Onion Distributed by: The Joe Tea Company, Upper Montclair, NJ 07043-0255 (973)744-7502 Net Wt. 2 OZ UPC 743234001725 Net Wt. 5 OZ UPC 743234001800 (76164) | The Two Little Guys Company | Food | Class II | 1 |
| 27 Dec 2016 | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 | Immuno-Mycologics, Inc | Device | Class II | 1 |
| 27 Dec 2016 | cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis. | Roche Diagnostics Corporation | Device | Class II | 1 |
| 27 Dec 2016 | Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center | Philips Electronics North America Corporation | Device | Class II | 1 |
| 27 Dec 2016 | OEC 9800. MDL Numbers: D222250, D141598 | GE OEC Medical Systems, Inc | Device | Class II | 2 |
| 27 Dec 2016 | Whole Foods Markets Lobster Bisque Distributed by: Whole Foods Market, Englewood Cliffs, NJ 07652 UPC: 8-80632-00100 (76126) | Whole Foods Market Northeast Regional Office | Food | Class II | 1 |
| 27 Dec 2016 | Roland MANZANILLA OLIVES STUFFED WITH ANCHOVIES, DR. WT. 3 OZ. (85g), UPC Code: 41224714021 and Case UPC Code: 10041224714028, Item # 71402, PRODUCT OF SPAIN | Roland Foods, LLC. | Food | Class II | 1 |
| 24 Dec 2016 | Farm to Market Foods Green Bean Casserole Code #1958 Net Wt. 6/1.95 lb. Trays with 6/.05 oz. Frenchs Fried Onions; Farm to Market Foods Green Bean Casserole Code #1971 Net Wt. 4/3.85 lb. Bags with 4/.15 oz. Frenchs Fried Onions UPC: 617037959029 | Farm To Market Foods | Food | Class II | 3 |
| 23 Dec 2016 | Optilite IgG4 Kit Product Code: LK009.OPT.A | The Binding Site Group, Ltd. | Device | Class III | 1 |
| 23 Dec 2016 | Brilliance iCT | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 23 Dec 2016 | BrightView XCT | Philips Medical Systems (Cleveland) Inc | Device | Class II | 2 |
| 23 Dec 2016 | Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the… | Atrium Medical Corporation | Device | Class II | 7 |
| 23 Dec 2016 | Alaska Salmon Bites (jerky), Spicy Fireweed Honey flavor, Dear North brand, Item # 2001, net wt. per pouch: 2 oz. UPC 8 15036 02001 0 | Individual firm, name withheld | Food | Class II | 2 |
| 22 Dec 2016 | Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set. | Flower Orthopedics Corporation | Device | Class II | 1 |
| 22 Dec 2016 | Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30 | Aurobindo Pharma USA Inc | Drug | Class II | 1 |
| 22 Dec 2016 | Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31. (76142) | Roxane Laboratories, Inc. | Drug | Class II | 1 |
| 22 Dec 2016 | Ambrosia Quality Foods Brand 4/1 gallon Worcestershire Sauce Net 128 Fl. Oz. (76155) | Schreiber Food International | Food | Class II | 1 |
| 22 Dec 2016 | Bon Ton-Sour Cream & Onion Flavored Potato Chips sold in 2.75 oz, 1.5 oz. bags | Bickel's Snack Foods Inc | Food | Class I | 7 |
| 21 Dec 2016 | IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 21 Dec 2016 | AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved… | PerkinElmer Health Sciences, Inc. | Device | Class III | 3 |
| 21 Dec 2016 | Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 21 Dec 2016 | Jon Donaire Ice Cream Layer Cake, Deliciously moist white cake with rich, creamy strawberries & cream ice cream, NET WT 4 LB 8 OZ, KEEP FROZEN, UPC 0 49800 04776 1 (retail), Product Code 04776 --- Rich Products Corp., Buffalo, NY 14213 | Rich Products Corp | Food | Class II | 4 |
| 20 Dec 2016 | Comprehensive Reverse Shoulder System Humeral Tray Model 115340 | Zimmer Biomet, Inc. | Device | Class I | 1 |
| 20 Dec 2016 | Accu-Chek Connect Diabetes Management App | Roche Diabetes Care, Inc. | Device | Class II | 1 |
| 20 Dec 2016 | VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 20 Dec 2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway,… | Sun Pharmaceutical Industries, Inc. | Drug | Class III | 2 |
| 20 Dec 2016 | Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17 | Accord Healthcare, Inc. | Drug | Class II | 1 |
| 20 Dec 2016 | Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA. | Mylan LLC. | Drug | Class II | 4 |
| 19 Dec 2016 | Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3. | Apotex Inc. | Drug | Class III | 1 |
| 19 Dec 2016 | Bakers Corner Vanilla Instant Pudding & Pie Filling, UPC 0 41498 15253 6 Distributed by ALDI; Best Choice Vanilla pudding UPC 0 70038 31218 5 Distributed by Associated Wholesale Grocers, INC(AWG) and Always Save Vanilla Pudding, UPC 0 70038 31200 0, Distributed by Associated Wholesale Grocers, INC; 3.4 oz. | Subco Foods of Wisconsin, Inc. | Food | Class I | 4 |
| 19 Dec 2016 | Gonsalves Sugar Coated Almonds, Net Wt. 12 oz. Distributed by The Gonsalves Company, Smithfield, RI 02917 UPC number 20539-64550 (75917) | The Henry Gonsalves Co. | Food | Class II | 1 |
| 17 Dec 2016 | Chocolate Premium Chocolate Treats Vanilla Caramels packaged under the following labels: (1) Weigel's Mountain Valley Premium Chocolate Treats Milk Chocolate Vanilla Caramels, 2.75 oz (78g) Tube snack Bag UPC Code: 024354705039; (2) Royal Farms Market Place Premium Chocolate Treats Milk Chocolate Vanilla Caramels… (76009) | New American Food Products, LLC. | Food | Class I | 1 |
| 16 Dec 2016 | MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 16 Dec 2016 | Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 16 Dec 2016 | Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg. | Covidien LLC | Device | Class II | 1 |
| 16 Dec 2016 | Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis,… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 16 Dec 2016 | MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05 | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 16 Dec 2016 | Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00 | Aurobindo Pharma USA Inc | Drug | Class III | 1 |
| 16 Dec 2016 | Lite Creamy Alfredo, gluten free, Pasta Sauce; Glass jar, metal lid; NET WT. 15 OZ, CONT. NET 425g; UPC 41220898732 | Berner Food & Beverage, LLC | Food | Class II | 5 |
| 15 Dec 2016 | Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 14 Dec 2016 | SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143 (75978) | Organ Recovery Systems, Inc. | Device | Class II | 1 |
| 14 Dec 2016 | Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99 (75992) | Roxane Laboratories, Inc. | Drug | Class III | 1 |
| 13 Dec 2016 | Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair. (75951) | On-X Life Technologies, Inc. | Device | Class II | 1 |
| 13 Dec 2016 | Hot Cocoa, NOT FOR RETAIL SALE, Prod: 28OCT2016, BB: 28JUN2017, Net Weight: 907 g (2.0 lb), Best Before: 28JUN2017 | Arro Corporation | Food | Class II | 3 |
| 12 Dec 2016 | SwishTapered Implant | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 12 Dec 2016 | Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed. | Pentax of America Inc | Device | Class II | 1 |
| 12 Dec 2016 | Mikesell's Nacho Cheese FLAVORED TORTILLA CHIPS 2.25 OZ (64g) bag UPC 0 71104 00554 3 (76058) | Mike-Sells Potato Chip Co | Food | Class I | 1 |
| 9 Dec 2016 | Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane) | Philips Electronics North America Corporation | Device | Class II | 2 |
| 9 Dec 2016 | Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 9 Dec 2016 | SLIMFIT X capsules, packaged in a 60-cont bottle (75929) | Jersey Shore Supplements, LLC | Drug | Class I | 1 |
| 9 Dec 2016 | Kustard Kwik Mix 50 Lb. Paper Bags | Dorothy Dawson Food Products dba Dawson Foods | Food | Class I | 2 |
| 9 Dec 2016 | Buttermilk Solids FFE-8902: Lot # s 1608301-18, 42,650 pounds, packed in 50# poly lined Kraft paper bags, expiration date March 3rd, 2017. | Franklin Farms East | Food | Class I | 3 |
| 9 Dec 2016 | Vintners Path Chardonnay Seasons Greetings Basket #795 | Houdini Inc. | Food | Class I | 31 |
| 8 Dec 2016 | VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine. | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 8 Dec 2016 | Raley'ss Canned Cut Green Beans 14.5oz ; UPC: 4656700204 (76116) | Individual firm, name withheld | Food | Class II | 1 |
| 8 Dec 2016 | Earth Balance Vegan White Cheddar flavored Mac and Cheese, 6oz package, Cardboard box/carton, 12 packages per distributed case, Ambient storage. | Boulder Brands, LLC | Food | Class I | 2 |
| 8 Dec 2016 | Corn Tortillas, 18 Count-16 Oz./453 g 16 units per case, 10 Count- 8 Oz./283 g 20 units per case, Mini- 12 Oz. 18 units per case, packed in plastic bags | Tortillas Tita, LLC | Food | Class II | 2 |
| 7 Dec 2016 | Natural Ranch Seasoning, NET Wt. 50 lbs (22.73kg) | Dutch-American Foods Inc | Food | Class I | 12 |
| 2 Dec 2016 | Bariatric Bed - BAR600IVC | Invacare Corporation | Device | Class II | 4 |
| 2 Dec 2016 | RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures. (76319) | Individual firm, name withheld | Device | Class II | 1 |
| 2 Dec 2016 | Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model Number: 61430436 (800 mL, 12 bottles/case) - United States; Model Number: 6000179 (800 mL, 12 bottles/case) - Canada, Ecolab, St. Paul, MN 55102, NDC 47593-265-36 | Ecolab, Inc. | Drug | Class III | 1 |
| 1 Dec 2016 | Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP). | Philips Electronics North America Corporation | Device | Class II | 4 |
| 30 Nov 2016 | AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devices are packaged… | AtriCure, Inc. | Device | Class II | 1 |
| 30 Nov 2016 | MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA (75753) | Individual firm, name withheld | Drug | Class I | 1 |
| 29 Nov 2016 | CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 29 Nov 2016 | Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma (75818) | Sekisui Diagnostics P.E.I. Inc. | Device | Class II | 1 |
| 29 Nov 2016 | Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single drain, in-line connector and suction control stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain with in-line connector and suction control… | Atrium Medical Corporation | Device | Class II | 10 |
| 23 Nov 2016 | Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds | Medline Industries Inc | Device | Class II | 1 |
| 21 Nov 2016 | Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate… | INO Therapeutics (dba Ikaria) | Device | Class II | 1 |
| 7 Nov 2016 | MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel… | Bayer Healthcare | Device | Class II | 1 |
| 31 Oct 2016 | HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions. | Smiths Medical ASD, Inc. | Device | Class III | 1 |
| 25 Oct 2016 | NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a… | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 19 Oct 2016 | Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are intended for use with a surgical driver… | Greatbatch Medical | Device | Class II | 1 |
| 18 Oct 2016 | Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management | Teleflex Medical | Device | Class II | 1 |
| 13 Oct 2016 | Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30 (75442) | Individual firm, name withheld | Drug | Class III | 1 |
| 6 Oct 2016 | SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion… | Soft Computer Consultants, Inc. | Device | Class II | 2 |
| 29 Sep 2016 | Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits.… (75338) | Thayer Medical Corporation | Device | Class II | 1 |
| 29 Sep 2016 | Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures. | Mako Surgical Corporation | Device | Class II | 1 |
| 29 Sep 2016 | Market District Wasabi Soybeans; Net Wt. 6 OZ.; Best By 3/6/17 | Giant Eagle, Inc. | Food | Class II | 1 |
| 7 Sep 2016 | Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No.… | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 1 |
| 26 Aug 2016 | ELDER PAINTSIL'S FANTE KENKEY, NET WT. 1.20, UPC: 6 61799 58167 7, MANUFACTURED BY VICTORY GENERAL FOODS IN WORCESTER, MA 01603 | Victory General Foods Inc | Food | Class II | 2 |
| 16 Aug 2016 | SYNEDREX, Powerful stimulant weight loss solution, 45 capsules (UPC 764779-224592). Brand: Metabolic Nutrition. | IQ Formulations, LLC | Food | Class II | 9 |
| 20 Jul 2016 | ASK Naturally Creative; 3 Bean Medley Salad; Net Wt. 10 lb. or Net Wt. 4 LB. | ASK Foods Inc | Food | Class I | 2 |
| 9 May 2016 | Promote with Fiber Vanilla, 8oz metal can | Abbott Nutrition | Food | Class II | 6 |
| 5 May 2016 | The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only. | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 2 |
| 22 Apr 2016 | Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes | Acumedia Manufacturers, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized… | Mesa Laboratories Inc | Device | Class II | 1 |
| 28 Mar 2016 | Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure | Merge Healthcare, Inc. | Device | Class II | 1 |
| 9 Mar 2016 | Spaghetti Soup; Annie's Kitchen, 2966 Stumptown Rd, Ronks, PA 17572 16 FL OZ | Annie's Kitchen | Food | Class II | 2 |
| 26 Feb 2016 | Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Highly sensitive… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 19 Feb 2016 | Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. | Villa Radiology Systems LLC | Device | Class II | 4 |
| 17 Nov 2015 | Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 3 Sep 2015 | Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 31 May 2015 | The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 10 Dec 2014 | Giant Eagle Apple Pistachio Salad with Chicken, NET WT 15 oz. | Giant Eagle, Inc. | Food | Class I | 2 |
| 11 Sep 2014 | Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the… | The Binding Site Group, Ltd. | Device | Class II | 7 |
| 20 Aug 2014 | Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 20 May 2014 | Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg (76166) | Cambrex Charles City Inc | Drug | Class II | 1 |