| 18 Jul 2016 | Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22, | GlaxoSmithKline, LLC | Drug | Class II | 4 |
| 8 Jul 2016 | Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body | Carestream Health Inc | Device | Class II | 1 |
| 1 Jul 2016 | RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 29 Jun 2016 | TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS Event 74591 | Vital Care Compounder, LLC | Drug | Class II | 1 |
| 28 Jun 2016 | DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10 | Golden State Medical Supply Inc. | Drug | Class III | 1 |
| 27 Jun 2016 | The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall. | Beckman Coulter Inc. | Device | Class II | 1 |
| 27 Jun 2016 | buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86 | Sun Pharmaceutical Industries, Inc. | Drug | Class III | 1 |
| 24 Jun 2016 | BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood. | Becton, Dickinson and Company, BD Biosciences | Device | Class II | 1 |
| 24 Jun 2016 | 2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otology /Neurotology/ Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy. They are intended to be used… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 23 Jun 2016 | Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 23 Jun 2016 | Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery. | Varian Medical Systems, Inc. | Device | Class II | 2 |
| 23 Jun 2016 | Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32 | Hospira Inc. | Drug | Class II | 1 |
| 22 Jun 2016 | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and… | Nobel Biocare Usa Llc | Device | Class II | 1 |
| 22 Jun 2016 | AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl… | Sorin Group USA, Inc. | Device | Class II | 1 |
| 22 Jun 2016 | Bolthouse Farms Chocolate Protein Plus: 22 g protein per bottle + 21 vitamins & minerals. Packaged in 11 oz./325 mL - item number PPC3BF9; 15.2 oz/450 mL I item number: PPC4BF6;- US; PPC4BC6 - Canada; 32 oz./946 mL; item number PPCQBF6 - US, PPCQBC6 - Canada: Selling Unit UPC Case GTIN 11 oz. 0-71464-01868-9… | Wm Bolthouse Farms Inc | Food | Class II | 7 |
| 21 Jun 2016 | MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636 | Encore Medical, Lp | Device | Class II | 1 |
| 21 Jun 2016 | Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 5 |
| 20 Jun 2016 | PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the physician. Event 74464 | Name withheld | Device | Class II | 1 |
| 20 Jun 2016 | Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope Event 74515 | Name withheld | Device | Class II | 1 |
| 17 Jun 2016 | MOSAIQ Oncology Information System | Elekta, Inc. | Device | Class II | 1 |
| 16 Jun 2016 | Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is disposable, for temporary single patient use, with a contemplated implant… | Medtronic Inc., Cardiac Rhythm and Heart Failure | Device | Class II | 1 |
| 16 Jun 2016 | 5.0mm Round Fluted Bur, Super Long | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 2 |
| 15 Jun 2016 | Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 15 Jun 2016 | Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 14 Jun 2016 | The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution. | WalkMed Infusion, LLC | Device | Class II | 2 |
| 14 Jun 2016 | Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein. | WalkMed Infusion, LLC | Device | Class II | 15 |
| 14 Jun 2016 | Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes | Philips Medical Systems (Cleveland) Inc | Device | Class II | 2 |
| 14 Jun 2016 | 3015 Choco Praline Graham Blend Net Weight: 25 lbs/11.34 kgs Event 74413 | Parker Products, Inc. | Food | Class II | 1 |
| 14 Jun 2016 | Baked in the Sun 4 Pack Smore's Muffin, Wholesale item (food service), not labeled for individual retail sale. 4 pcs/carton Event 74439 | Baked in the Sun Corporation | Food | Class II | 1 |
| 13 Jun 2016 | ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360. Cardiovascular. | Cardiovascular Systems Inc | Device | Class II | 1 |
| 13 Jun 2016 | Kellogg's Special K Mini Brownies Blondie, 6 ct, 4.44 oz. | Kellogg Company | Food | Class II | 19 |
| 10 Jun 2016 | TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six… | Biomet, Inc. | Device | Class II | 1 |
| 10 Jun 2016 | Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx” Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is… | Dako North America Inc. | Device | Class II | 1 |
| 10 Jun 2016 | SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10. | Valeant Pharmaceuticals North America LLC | Drug | Class III | 1 |
| 10 Jun 2016 | Tosi Cappuccino Crunch Almond SuperBites, 12 bars per pack, Net Wt. 2.6 ounces, UPC 755918046106 | Simple Health LLC | Food | Class I | 2 |
| 10 Jun 2016 | Raw Pistachios, packaged in a 6 oz. clear, plastic bag, sold under Crescent brand. UPC 8 95296 00103 5. Product is labeled in part: “Crescent *** PISTACHIO RAW Net Wt. 6 oz. (170g) *** Ingredients: Raw Pistachios *** Distributed by Crescent Specialty Foods, Inc. Everett, WA ***www.csf1.com***". Event 74396 | Crescent Specialty Foods Inc | Food | Class I | 1 |
| 9 Jun 2016 | Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the… | Bayer Healthcare | Device | Class II | 1 |
| 8 Jun 2016 | HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps,… | Terumo Cardiovascular Systems Corporation | Device | Class II | 4 |
| 8 Jun 2016 | GE Healthcare, Discovery MR750w | GE Healthcare, LLC | Device | Class II | 1 |
| 8 Jun 2016 | Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems. | Beckman Coulter Inc. | Device | Class II | 1 |
| 8 Jun 2016 | Cajun Hot Mix 6 OZ. packaged in clear plastic bags with sticker label. This product has multiple brands. All brands are under the same UPC 052545002681. Brand names include Big R. Stores, Bomgaar's, C-A-L Ranch Store's, Coastal, Family Choice, Fin Feather Furn Outfitter's, Gebos, Sportman's warehouse, theisen's, | Rucker's Wholesale & Service Co., Inc. | Food | Class I | 8 |
| 7 Jun 2016 | Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998; 9641078; 9327510; 9422885; 9554330; 9651850;… | Synthes (USA) Products LLC | Device | Class II | 1 |
| 7 Jun 2016 | Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48 Event 74319 | Lyne Laboratories, Inc. | Drug | Class III | 1 |
| 6 Jun 2016 | Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available… | Covidien, LLC | Device | Class II | 2 |
| 6 Jun 2016 | Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) Event 74391 | Name withheld | Device | Class II | 1 |
| 6 Jun 2016 | SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 6 Jun 2016 | Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. | Name withheld | Device | Class II | 28 |
| 6 Jun 2016 | Waffle Works Double Chocolate Waffle Sandwich Snacks Net Wt. 4 OZ.. Distributed By: Herr Foods, Inc., Nottingham, PA 19363. June0616 through February0117 | Herr Foods, Inc. | Food | Class I | 1 |
| 3 Jun 2016 | Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01 Event 74325 | Name withheld | Drug | Class III | 1 |
| 3 Jun 2016 | Day Break Cranberry Almond Bar 6x5, UPC: 637480055062, Case UPC: 637480059060. Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage | Atkins Nutritionals, Inc. | Food | Class I | 11 |
| 3 Jun 2016 | Bayou Brothers Creole Sauce NET WT 33OZ. (2 LBS 1 OZ) 936g packaged in a glass jar | Riba Foods Inc | Food | Class II | 1 |
| 2 Jun 2016 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to: multiple infusions of fluids, medications, or… | Arrow International Inc | Device | Class II | 1 |
| 2 Jun 2016 | Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient. Event 74547 | Parker Medical | Device | Class II | 1 |
| 2 Jun 2016 | Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation. | Arrow International Inc | Device | Class II | 2 |
| 2 Jun 2016 | CLIF BAR Nuts & Seeds energy bar, 68 g bar. Almonds, Peanuts, Pumpkin Seeds UPC: 7-22252-16101-7; 12 count and 6 count packages INGREDIENTS: Organic Brown Rice Syrup, Organic Rolled Oats, Soy Protein Isolate, Sunflower Seeds, Organic Almonds, Organic Cane Syrup, Organic Peanut Butter, Rice Flour, Organic Roasted… | Clif Bar And Company | Food | Class I | 4 |
| 2 Jun 2016 | Navitas Naturals Superfood Hemp bar: Creamy Peanut, Hemp, Nut Bar. Net Wt. 1.4 oz/40 G. Gluten free. Ingredients: Organic Roasted Cashews, Almonds Honey, Evaporated Cane Sugar, Crisp Brown rice, roasted peanuts, tapioca syrup, roasted sunflower seeds, quinoa crisp, almond butter, toasted hemp seed, sea salt, not-soy… | Navitas, LLC. | Food | Class I | 4 |
| 1 Jun 2016 | AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 | Stryker Sustainability Solutions | Device | Class I | 1 |
| 1 Jun 2016 | Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01 | Aidarex Pharmaceuticals LLC | Drug | Class III | 1 |
| 1 Jun 2016 | Mountain Thins Trail Mix flavor, packaged in a stand-up film pouch (resealable), net wt. 5.3 oz. The UPC is 0 41770 33370 7 Event 74352 | Brown & Haley Inc. | Food | Class I | 1 |
| 31 May 2016 | Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue | Synthes (USA) Products LLC | Device | Class II | 1 |
| 31 May 2016 | ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy. | Hologic, Inc | Device | Class II | 1 |
| 31 May 2016 | Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant. | Synthes (USA) Products LLC | Device | Class II | 11 |
| 31 May 2016 | Kashi Chewy Trail Mix Granola Bars 1.2 oz individual bar 6 count retail carton (7.4 oz.), 12 carton per case; 35 count club store carton (42 oz.), 1 carton per case; 12 count food service carton (14.4 oz.), 6 carton per case | Kellogg Company | Food | Class I | 6 |
| 27 May 2016 | Domaine de Provence La Cucina Tart Shells Produced Exclusively for Sid Wainer& Son, New Bedford, MA UPC Code: 708152149119 Item Number: 149110 | Name withheld | Food | Class I | 2 |
| 27 May 2016 | Spicy Kimchi | WHOLE FOODS MARKET | Food | Class I | 4 |
| 26 May 2016 | Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician. | Medtronic Inc., Cardiac Rhythm and Heart Failure | Device | Class II | 1 |
| 26 May 2016 | ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 26 May 2016 | Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative… | Exactech, Inc. | Device | Class II | 2 |
| 26 May 2016 | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate… | Smith & Nephew, Inc. | Device | Class II | 6 |
| 25 May 2016 | LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest. | Physio-Control, Inc. | Device | Class II | 1 |
| 25 May 2016 | ONION BREADER, NET WEIGHT 25 lbs, MFG FOR: LEE ROY SELMON’S, TAMPA, FL 33609 | Magic Seasoning Blends, LLC | Food | Class II | 6 |
| 24 May 2016 | VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883… | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 24 May 2016 | QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide. | Hardy Diagnostics | Device | Class II | 1 |
| 24 May 2016 | CENTURION Vision System | Alcon Research, Ltd. | Device | Class II | 1 |
| 24 May 2016 | Craft Cake Flour (M4138), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214. | Grain Craft, Inc. | Food | Class II | 15 |
| 24 May 2016 | Eillien's Salted Sunflower Kernels Net WT 4 oz (113G) sealed in original plastic packaging and contained in Garden Fresh Foods Cool Breeze Health SALD Kit #2052, Net WT 7.06 lbs, 3.20 kg. 0 01 11596 72052 1. | Garden-Fresh Foods, Inc. | Food | Class I | 3 |
| 23 May 2016 | DeVilbiss Model 7305P-D Powered Suction Unit | DeVilbiss Healthcare LLC | Device | Class II | 1 |
| 23 May 2016 | OT1000 Series Orthopedic Surgical Tables | Steris Corporation | Device | Class II | 1 |
| 23 May 2016 | PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy | Baxter Healthcare Corp. | Device | Class II | 1 |
| 20 May 2016 | Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. | Amerx Health Care Corp. | Device | Class II | 1 |
| 20 May 2016 | K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 20 May 2016 | The sunflower kernels roasted and salted were packed in a 30 lbs. corrugated box with a poly liner with the following labeling: Roasted and Salted 30 lbs brown cardboard box labeled "SUNFLOWER KRNLS", "INGREDIENTS: Sunflower Kernels, Peanut Oil, Salt" "NET WT. 30 LBS. (13.61 KG.)" ; "CJ DANNEMILLER CO., NORTON, OHIO… | C.J. Dannemiller Company, Inc. | Food | Class I | 2 |
| 19 May 2016 | Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted… | Devicor Medical Products Inc | Device | Class II | 1 |
| 19 May 2016 | Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41 | West-Ward Columbus Inc | Drug | Class III | 1 |
| 19 May 2016 | Dehydrated chipotle powder from Silva International packaged in a 50 lb. poly-lined cardboard box. | Silva International Inc. | Food | Class II | 2 |
| 19 May 2016 | Kroger SALAD TOPPERS Roasted & Salted Sunflower Kernels NET WT 3.5 OZ (99G) INGREDIENTS: SUNFLOWER KERNELS, COTTONSEED AND/OR SUNFLOWER OILS, SALT DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 02127 4 | The Kroger Co | Food | Class I | 2 |
| 17 May 2016 | Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. | CSL Behring GmbH | Device | Class II | 1 |
| 17 May 2016 | cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay. | Roche Molecular Systems, Inc. | Device | Class III | 1 |
| 16 May 2016 | Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red color kit: 845174005464; UPC Lime color kit:… | Lifeline First Aid LLC | Device | Class II | 2 |
| 16 May 2016 | enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 16 May 2016 | Quaker Quinoa Granola Bars, Chocolate Nut Medley packaged in a multi colored box with brown lettering. 5, 1.23 oz bars per box. | The Quaker Oats Company | Food | Class I | 2 |
| 13 May 2016 | Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications. | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution | Device | Class II | 1 |
| 13 May 2016 | B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY | Medaus, Inc. | Drug | Class II | 88 |
| 13 May 2016 | Dr. Praeger's Purely Sensible Foods Jumbo California Veggie Burger (Vegan), 5.5 oz., 10 lbs (4.54.kg), Best if used by: May 17, 2018, UPC (01) 00080868 01011, Dr. Praegers Sensible Foods, Elmwood Park, NJ 07407 | Name withheld | Food | Class I | 23 |
| 12 May 2016 | Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System. | CareFusion 303, Inc. | Device | Class II | 1 |
| 11 May 2016 | Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities. | Siemens Healthcare Diagnostics Inc. | Device | Class II | 1 |
| 11 May 2016 | aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089 Event 74146 | The Aloe Source | Drug | Class II | 1 |
| 11 May 2016 | Whole Foods Market Korean BBQ Sauce NET WT 12 OZ (340g) packaged in a glass bottle | Whole Foods Market | Food | Class I | 1 |
| 11 May 2016 | Productos Del Campo Castillo Chile Habanero (Fresh Habanero Peppers) Event 74147 | Montero Farms | Food | Class I | 1 |
| 10 May 2016 | Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612 | Allergan Sales, LLC | Drug | Class II | 2 |
| 10 May 2016 | Wegmans Fudgy & Chewy Brownies with Chocolate Chips 14 oz., UPC#7789032990 | Wegmans Food Markets, Inc. | Food | Class I | 7 |
| 9 May 2016 | cobas Liat Analyzer | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 9 May 2016 | VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were… | ORTHO-CLINICAL DIAGNOSTICS | Device | Class III | 1 |
| 9 May 2016 | Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173, | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 9 May 2016 | Natural Directions Organic Mixed Vegetables, frozen, net wt. 12 oz. UPC 0 15400 19672 7 | Norpac Foods, Inc. (Plant #8) | Food | Class I | 2 |
| 9 May 2016 | Piggly Wiggly, Yellow Cut Corn, Net Wt 32oz (2 lbs), 907g bags, Distributed by Piggly Wiggly LLC, Keene, NH 03431. | Mccall Farms Inc | Food | Class I | 1 |
| 6 May 2016 | The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Event 74311 | Custom Ultrasonics, Inc. | Device | Class II | 1 |
| 6 May 2016 | simple truth organic Mixed Vegetables NET WT 10 OZ (283g) KEEP FROZEN INGREDIENTS: ORGANIC CARROTS, ORGANIC CORN ORGANIC PEAS, GREEN BEANS. | The Kroger Co | Food | Class I | 1 |
| 6 May 2016 | Morelos Whole Dried Shrimp Net. Wt. 1 oz.; El Gordo Whole Dried Shrimp Net. Wt. 1 oz.; La Azteca Whole Dried Shrimp Net. Wt. 1 oz. all packaged in cellophane bags | El Gordo Spices, LLC | Food | Class I | 2 |
| 5 May 2016 | 0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11 | Pharmedium Services, LLC | Drug | Class II | 75 |
| 5 May 2016 | Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03 | KVK-Tech, Inc. | Drug | Class III | 1 |
| 5 May 2016 | Hightower Corn Relish UPC: 8-51570-00386-7 5 pound plastic containers Manufactured By Pita Pal Foods Keep Refrigerated | Pita Pal Foods LP | Food | Class I | 4 |
| 5 May 2016 | Central Markets Organics Green Peas, frozen, net wt. 16 oz. UPC 4122010240 Central Markets Organics Green Peas, frozen, net wt. 12 oz. UPC 4122081674 | Twin City Foods Inc | Food | Class I | 2 |
| 4 May 2016 | Crunchy Wheatberry Salad Kit 12.75 LB (5.78kg) ***SUNFLOWER SEED POUCH: INGREDIENTS SUNFLOWER KERNELS (Sunflower Kernels, Canola and/or Peanut oil and/or Sunflower Oil Citric Acid) Manufactured by Sandridge Food Corporation, Medina, Ohio 44256 Event 74136 | Sandridge Food Corporation | Food | Class I | 1 |
| 29 Apr 2016 | Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248 | Integra LifeSciences Corp. | Device | Class II | 1 |
| 28 Apr 2016 | IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN… | CMP Industries, Llc | Device | Class II | 2 |
| 27 Apr 2016 | Los Mart Chicharrin Rueda, 1 lb, Packaged & Distributed by Martinez Imports, 1 Market St. Bldg. #6, Passaic, NJ 07055 | Martinez Imports, LLC | Food | Class II | 5 |
| 27 Apr 2016 | Product is labeled as "eban's BAKEHOUSE CRISPY PECAN SHORTBREAD COOKIES Net Weight 8.5 oz (241g) " . The cookies are packaged 6 per container. The container is a plastic tub with lid and tamper proof band. Event 74016 | Eban Bakery Gluten Free Breads and Baked Goods LLC | Food | Class II | 1 |
| 25 Apr 2016 | Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ) | GSK Consumer Healthcare | Device | Class III | 1 |
| 22 Apr 2016 | CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523 Event 74220 | Name withheld | Drug | Class III | 1 |
| 22 Apr 2016 | Frozen Organic Premium Sweet Baby Peas, Organic by Nature brand, net wt. 5 lb. The UPC is 8 46358 00063 3. Frozen IQF Organic Premium Sweet Baby Peas, Organic by Nature brand, net wt. 4 lb. The UPC is 8 46358 00069 5. Frozen Organic Premium Quality Sweet Peas, Organic by Nature brand (Canada); net wet 2.5 kg. The UPC… | CRF Frozen Foods, LLC | Food | Class I | 4 |
| 21 Apr 2016 | Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005. | Musculoskeletal Transplant Foundation, Inc. | Device | Class II | 1 |
| 20 Apr 2016 | Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0011-72 | Pharmakon Pharmaceuticals, Inc. | Drug | Class II | 88 |
| 20 Apr 2016 | PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang Chow Pharm. Ind. Corp., remaining labeling contains Chinese characters. | Murray International Trading Co., Inc. | Drug | Class II | 14 |
| 14 Apr 2016 | MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore… | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 10 Apr 2016 | Reser's Deviled Egg Potato Salad, Refrigerated, Retail package, Net wt. 3 lbs. UPC 0 71117 00480 9; Reser's Deviled Egg Potato Salad, Refrigerated, Foodservice product, net wt. 8 lbs. UPC 71117 00225; Safeway Deviled Egg Potato Salad, Refrigerated, Net wt. 16 oz. UPC 0 21130 06688 9. | Reser's Fine Foods, Inc. - Century | Food | Class I | 8 |
| 9 Apr 2016 | Frozen three pepper and onion blends labeled as: a) Harris Teeter(TM) brand THREE PEPPER & ONION BLEND, NET WT 12 OZ (340g), UPC 72036 71681, PROUDLY DISTRIBUTED BY HARRIS TEETER, LLC, MATTHEWS, NC 28105 b) Kroger(R) 3 PEPPER & ONION BLEND, onions, green bell peppers, yellow bell peppers, & red bell peppers, RECIPE… | The Pictsweet Company | Food | Class I | 12 |
| 6 Apr 2016 | Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the… | Pentax Medical Company | Device | Class II | 16 |
| 5 Apr 2016 | cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor… | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 1 Apr 2016 | Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes | Philips Medical Systems (Cleveland) Inc | Device | Class II | 3 |
| 1 Apr 2016 | R No Sugar Added; Dark Chocolate 34 g/1.2 oz. Ross Chocolates, 4061 Butters Road, Scotch Creek, BC UPC 726007100054 Best Before: 191018 Event 73876 | Platinum Distribution Inc | Food | Class I | 1 |
| 30 Mar 2016 | AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1… Event 73696 | Amd-Ritmed, Inc. | Device | Class II | 1 |
| 30 Mar 2016 | PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35. | QuVa Pharma, Inc. | Drug | Class I | 1 |
| 25 Mar 2016 | All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Reliable Rexall-A Compounding Pharmacy | Drug | Class I | 70 |
| 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 I | 1 |
| 17 Mar 2016 | Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028 | Medtronic Navigation, Inc.-Littleton | Device | Class II | 1 |
| 17 Mar 2016 | Medtronic Navigation O-arm 02 surgical x-ray imaging system | Medtronic Navigation, Inc.-Littleton | Device | Class II | 1 |
| 16 Mar 2016 | Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10 Event 73778 | Actavis Pharma Inc | Drug | Class III | 1 |
| 16 Mar 2016 | SEAFOOD BALL COMBO ASSORTI BOULETTES AUX PRODUCTS DE MER FISH BALL, FRIED FISH BALL, FRIED SHRIMP BALL, FISH BALL WITH DACE, CUTTLEFISH BALL, Net Wt 260g/9.2oz, UPC 0 68636 05205 2, Product of Canada, KEEP REFRIGERATED | Way Fong LLC | Food | Class I | 2 |
| 3 Mar 2016 | dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection | Dynarex Corporation | Device | Class II | 1 |
| 3 Mar 2016 | Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 | Circulatory Technology Inc | Device | Class II | 1 |
| 2 Mar 2016 | IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N… | CMP Industries, Llc | Device | Class II | 1 |
| 24 Feb 2016 | Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 17 Feb 2016 | Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum crutch, tall adult, 8 pairs per case | Medical Depot Inc. | Device | Class II | 6 |
| 16 Feb 2016 | 6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau… | Synthes (USA) Products LLC | Device | Class II | 7 |
| 16 Feb 2016 | Pecorino Aged in Walnut Leaves Mitica, PLU 0294239, Whole Foods, 95 Houston St. New York, NY 10002 wrapped in plastic wrap; Pecorino Aged in Walnut Leaves Product of Italy, PLU 290107, Dist. by Whole Foods Market 50 Bowie Street Austin, TX 78703, wrapped in plastic wrap., | Whole Foods Market | Food | Class I | 1 |
| 12 Feb 2016 | Maytag Blue Cheese. Wedges and wheels are packaged in an aluminum foil wrapper and shipped in cardboard box. The wedges and wheels are packaged in the following sizes: 1) 4 LB. wheel, UPC 8 54089 00114 0; 2) 2 LB. wheel, UPC 8 54089 00112 6; 3) 1 oz. wedges, UPC 8 54089 00102 7; 4) 4 oz. wedges, UPC 8 54089 00104 1;… Event 73327 | Maytag Dairy Farms Inc | Food | Class I | 1 |
| 3 Feb 2016 | Margaritaville 4.16 ounce packages of Banana creme pie filling mix packaged in a yellow, red, and blue box with white lettering. Event 73217 | Jel Sert Co. | Food | Class I | 1 |
| 31 Jan 2016 | Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 30 Jan 2016 | Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 29 Jan 2016 | Freeze dried banana 1/4 diced packaged in 20 lb. containers with white label and black lettering. Event 73215 | R. J. Van Drunen and Sons Inc. | Food | Class I | 1 |
| 26 Jan 2016 | Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560; | Apotex Scientific, Inc | Drug | Class III | 3 |
| 19 Jan 2016 | HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter. Event 74078 | Ergoactives, Llc | Device | Class II | 1 |
| 7 Jan 2016 | HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular… | Heartware, Inc. | Device | Class I | 1 |
| 21 Dec 2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3. | Noven Pharmaceuticals, Inc. | Drug | Class II | 3 |
| 15 Dec 2015 | Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com | Bee Extremely Amazed LLC | Drug | Class I | 14 |
| 25 Nov 2015 | Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 23 Nov 2015 | The ZYTO Tower is the input device to program the software with various virtual items. | ZYTO Technologies, Inc. | Device | Class II | 2 |
| 16 Nov 2015 | Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium… | Nephron Pharmaceuticals Corp. | Device | Class II | 2 |
| 21 Sep 2015 | Baby Omega 3 Dietary supplement (in liquid form), 15 ml and 14 ml in glass bottle with dropper dispenser. | Zarbee's Naturals Inc. | Food | Class III | 2 |
| 21 Aug 2015 | fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450 | Cantrell Drug Company | Drug | Class I | 13 |
| 2 Jul 2015 | Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180 Event 72227 | XTREME Z DISTRIBUTORS INC | Drug | Class I | 1 |
| 10 Jun 2015 | Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS | Vital Care Compounder | Drug | Class II | 3 |
| 29 Apr 2015 | Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY | Centurion Medical Products Corporation | Device | Class II | 1 |
| 3 Apr 2015 | Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2. | Medtest Holdings, Inc. | Device | Class II | 1 |
| 11 Mar 2015 | ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters. Event 73461 | Name withheld | Device | Class I | 1 |
| 9 Sep 2013 | *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; *** 3) Product labeled… | Hospira Inc. | Device | Class II | 5 |
| 9 May 2013 | NovaPACS – versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) | Novarad Corporation | Device | Class II | 1 |
| 8 Mar 2013 | The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical… | Hospira Inc. | Device | Class II | 4 |
| 4 Feb 2013 | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral,… | Hospira Inc. | Device | Class II | 2 |