| 13 Aug 2014 | PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01 | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 7 Aug 2014 | Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426 | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 6 Aug 2014 | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 | Angiodynamics, Inc. | Device | Class II | 3 |
| 6 Aug 2014 | Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Community College Nursing. (68950) | HLI dba Humphreyline Inc | Drug | Class II | 1 |
| 5 Aug 2014 | CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch. | ICU Medical, Inc. | Device | Class II | 3 |
| 4 Aug 2014 | ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06. | Baxter Healthcare Corp | Drug | Class II | 1 |
| 31 Jul 2014 | CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01 | Ben Venue Laboratories Inc | Drug | Class II | 1 |
| 30 Jul 2014 | Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017 NDC 0009-3073-03 DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL, 1 mL Single-Dose Vial, Rx ONLY,… | Pfizer Inc. | Drug | Class III | 1 |
| 30 Jul 2014 | Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2. | Novartis Pharmaceuticals Corp. | Drug | Class III | 1 |
| 30 Jul 2014 | Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10 | Mckesson Packaging Services | Drug | Class II | 1 |
| 28 Jul 2014 | OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41. | Boehringer Ingelheim Roxane Inc | Drug | Class III | 1 |
| 27 Jul 2014 | IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 25 Jul 2014 | GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages. | GE Healthcare, LLC | Device | Class II | 1 |
| 25 Jul 2014 | Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10 | Sandoz Incorporated | Drug | Class II | 1 |
| 25 Jul 2014 | CaCoCo Superfood Drinking Chocolate; Global Warrior - Flavor Melody: Dark, Bitter-sweet, Medicinal, Energizing Raw Chocolate. Gluten-free/Vegan/Raw Sold in 8 .14 oz (231 g). o and 2 lb. bags. Ingredients: Cacao Beans, Cacao Butter, Maca, Carob, coconut Crystal Sugar, Mesquite, Wildcrafted Shilajit, Vanilla Bean,… | CaCoCo, Inc. | Food | Class I | 2 |
| 25 Jul 2014 | Natural Grocers Organic Chunks of Energy Carob Supergreens, 0.70 lb. random weight, Packaged in Plastic Bags, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228 (303) 986-4600 | Natural Grocers by Vitamin Cottage | Food | Class I | 2 |
| 24 Jul 2014 | Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage. | Philips Healthcare Informatics, Inc. | Device | Class II | 1 |
| 24 Jul 2014 | Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA | Wockhardt Usa Inc. | Drug | Class II | 1 |
| 24 Jul 2014 | Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6. | Fagron, Inc | Drug | Class II | 3 |
| 24 Jul 2014 | Product is in a 160 gram, light green tin container, labeled in part: "ecoato Sweet Paprika Powder Product of Spain" | The TJX Companies, Inc. | Food | Class I | 1 |
| 23 Jul 2014 | Double Offset Rasp Handle, Left Hand Nonsterile | Zimmer, Inc. | Device | Class II | 16 |
| 23 Jul 2014 | Sesame Ginger Dressing sold under the Whole Foods Market brand in plastic jars, 14 oz. per jar. This product is labeled to keep refrigerated. (68894) | D.A. Stein Culinary Group, LLC dba Brett Anthony Foods | Food | Class II | 1 |
| 22 Jul 2014 | Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer | Zimmer, Inc. | Device | Class II | 8 |
| 21 Jul 2014 | Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The… | Medtronic MiniMed Inc. | Device | Class II | 1 |
| 21 Jul 2014 | Allegro Original Marinade, 12.7 fl oz (375 mL), UPC 0 74964 00100 7 (68893) | Allegro Fine Foods Inc | Food | Class III | 1 |
| 21 Jul 2014 | Organic Carob Powder, Net Wt. 55lbs (25kg), Product Code: CAROB-100 (68880) | BrandStorm Inc | Food | Class I | 1 |
| 21 Jul 2014 | Ciranda Organic Carob Powder Light, Product Code 20030. Net Wt. 55.11 lbs / 25 kg. Ingredients: Organic Carob Powder. Manufactured in Italy. (68859) | Ciranda, Inc. | Food | Class I | 1 |
| 21 Jul 2014 | American Spoon Food Sour Cherry Marmalade, 9.5 oz in glass jars with metal lid e. Total package size (e.g. 12 packages per case): 12 jars per case (68872) | American Spoon Foods, Inc. | Food | Class II | 1 |
| 18 Jul 2014 | BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry. | BD Biosciences, Systems & Reagents | Device | Class III | 1 |
| 18 Jul 2014 | Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro Renal Products, Incorporated | Device | Class II | 15 |
| 18 Jul 2014 | Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion,… | ICU Medical, Inc. | Device | Class II | 9 |
| 17 Jul 2014 | Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely… | Nellcor Puritan Bennett Inc. (dba Covidien LP) | Device | Class II | 2 |
| 17 Jul 2014 | Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component. | Zimmer, Inc. | Device | Class II | 1 |
| 17 Jul 2014 | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). . | TomoTherapy Incorporated | Device | Class II | 1 |
| 17 Jul 2014 | PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve | Pentax Medical Company | Device | Class II | 1 |
| 17 Jul 2014 | Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5 (68891) | SST Corporation | Drug | Class II | 1 |
| 16 Jul 2014 | Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent… | AGFA Healthcare Corp. | Device | Class III | 1 |
| 16 Jul 2014 | VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human… | ORTHO-CLINICAL DIAGNOSTICS | Device | Class II | 1 |
| 16 Jul 2014 | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or… | TomoTherapy Incorporated | Device | Class II | 1 |
| 16 Jul 2014 | Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert. | Novocol, Inc. | Device | Class II | 2 |
| 16 Jul 2014 | Uncle Ben's(R) Ready Rice GARDEN VEGETABLE, with PEAS, CARROTS, AND CORN, NET WT. 8.8 OZ (250g), UPC 5480023334 | Mars Food US | Food | Class II | 1 |
| 15 Jul 2014 | Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company | Vascutek, Ltd. | Device | Class II | 1 |
| 15 Jul 2014 | VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 15 Jul 2014 | Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 14 Jul 2014 | Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical… (68935) | Individual firm, name withheld | Device | Class II | 1 |
| 14 Jul 2014 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07. | Wockhardt Usa Inc. | Drug | Class III | 1 |
| 14 Jul 2014 | King of Pops Key Lime Pie, frozen flavored pop cycle, Net Wt. 3.2oz., Hand Made by King of Pops, 4845 Chateau Ave., Unit D, Charleston, SC 29405 | Coastal KOP LLC dba King of Pops | Food | Class II | 2 |
| 12 Jul 2014 | Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30 | Daiichi Sankyo Pharma Development | Drug | Class II | 8 |
| 11 Jul 2014 | Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit. | Beevers Manufacturing & Supply, Inc. | Device | Class II | 1 |
| 11 Jul 2014 | Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery. | X Spine Systems Inc | Device | Class II | 1 |
| 11 Jul 2014 | Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a… (68838) | Individual firm, name withheld | Device | Class II | 1 |
| 11 Jul 2014 | Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum | Ortho Development Corporation | Device | Class II | 5 |
| 11 Jul 2014 | FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively… | Baxter Healthcare Corporation | Device | Class II | 1 |
| 11 Jul 2014 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90 | Jubilant Cadista Pharmaceuticals Inc. | Drug | Class II | 1 |
| 11 Jul 2014 | Simply Enjoy Chocolate Chip Walnut Cookies, 7oz. (68762) | Tate's Wholesale, Llc. | Food | Class II | 1 |
| 10 Jul 2014 | RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730. | Teleflex Medical | Device | Class III | 1 |
| 10 Jul 2014 | Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017. Product Usage: Used to conduct syncope examinations. | Medical Positioning Inc | Device | Class II | 4 |
| 10 Jul 2014 | Ocean Garden Wild Co-treated Steak IVP 10LB 10 oz. UPC 076550080922 (68748) | Blue Venture Inc. | Food | Class II | 1 |
| 9 Jul 2014 | Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray… | Carestream Health, Inc. | Device | Class II | 1 |
| 9 Jul 2014 | Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is… | Nanosphere, Inc. | Device | Class II | 1 |
| 9 Jul 2014 | Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. | Teleflex Medical | Device | Class II | 1 |
| 8 Jul 2014 | Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone… | Gyrus Medical, Inc | Device | Class II | 1 |
| 8 Jul 2014 | Lindberg B-Complex, 50mg, 60 capsules (UPC 092865236601), 120 capsules (UPC 092865236120), 240 capsules (UPC 092865236243). | Nutrition Express Corporation | Food | Class II | 4 |
| 8 Jul 2014 | Whole Foods Caesar Salad Mini Net Wt 4 0z plastic shell | Whole Foods Market Group Inc. | Food | Class I | 2 |
| 7 Jul 2014 | VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, &… | Ortho-Clinical Diagnostics | Device | Class II | 3 |
| 7 Jul 2014 | SEQUATCHIE COVE CREAMERY, CUMBERLAND (cheese), 320 DIXON COVE ROAD, SEQUATCHIE, TN 37374 (68736) | Ledgendairy Cheeseworks, LLC DBA Sequatchie Cove Creamery | Food | Class II | 1 |
| 4 Jul 2014 | AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50) | Advandx Inc | Device | Class II | 1 |
| 3 Jul 2014 | IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other… (68719) | Intelerad Medical Systems | Device | Class II | 1 |
| 3 Jul 2014 | Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. | Codman & Shurtleff, Inc. | Device | Class II | 8 |
| 3 Jul 2014 | MuscleTech Amino Build, Fruit Punch flavored, Net Wt. 0.58 lbs (261g) UPC 31646-70392 and Net Wt. 0.96 lbs (435g) UPC 31656-70479 (68816) | Milk Specialties Co | Food | Class II | 1 |
| 3 Jul 2014 | Tiger-X, Blister Packs | GM Manufacturing Inc. | Food | Class II | 46 |
| 2 Jul 2014 | DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both… | AGFA Healthcare Corp. | Device | Class II | 1 |
| 2 Jul 2014 | TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 13MM X 18 CM NAIL, 125o, REF 71675203, QTY (1),… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 2 Jul 2014 | INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc. | Carestream Health Inc. | Device | Class III | 2 |
| 2 Jul 2014 | CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation. | Dynarex Corporation | Device | Class II | 1 |
| 2 Jul 2014 | E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01. | Bracco Diagnostic Inc | Drug | Class III | 1 |
| 1 Jul 2014 | Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification… | PerkinElmer Health Sciences, Inc. | Device | Class II | 1 |
| 1 Jul 2014 | Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesis with or without… | Zimmer, Inc. | Device | Class II | 1 |
| 1 Jul 2014 | Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The… (68735) | Ansar Group, Inc. Dba Ansar Medical Technologies, Inc | Device | Class II | 1 |
| 1 Jul 2014 | Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA | Biomet, Inc. | Device | Class II | 1 |
| 1 Jul 2014 | PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during… | Zimmer, Inc. | Device | Class II | 2 |
| 1 Jul 2014 | Market Pantry Apple; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***market pantry Apple Fruit Pouch***NET WT 3.5 OZ (100g)***DISTRIBUTED BY TARGET CORPORATION MINNEAPOLIS, MN 55403***" UPC Code:… | Individual firm, name withheld | Food | Class II | 5 |
| 30 Jun 2014 | Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures. | Invivo Corporation | Device | Class II | 1 |
| 30 Jun 2014 | Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set | Synthes, Inc. | Device | Class II | 1 |
| 30 Jun 2014 | RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical. | Teleflex Medical | Device | Class II | 1 |
| 30 Jun 2014 | PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma | Ra Medical Systems Inc | Device | Class II | 1 |
| 27 Jun 2014 | Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable… | Brainlab AG | Device | Class II | 1 |
| 27 Jun 2014 | Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 27 Jun 2014 | PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data. | PerkinElmer Health Sciences, Inc. | Device | Class II | 1 |
| 27 Jun 2014 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-90 | Healix Infusion Therapy, Inc. | Drug | Class II | 5 |
| 27 Jun 2014 | Richards Too Good BBQ Sauce. 12 oz. Product is packaged in 12 oz tall glass bottles with metal screw caps and black heat resistant tamper seals. | Richard's Rub & Seasonings, LLC | Food | Class II | 3 |
| 26 Jun 2014 | Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging (68648) | Biosound Esaote, Inc. | Device | Class II | 1 |
| 26 Jun 2014 | Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. | Caraco Pharmaceutical Laboratories, Ltd. | Drug | Class II | 2 |
| 25 Jun 2014 | Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us | Medical Supply Liquidators Llc | Drug | Class II | 15 |
| 25 Jun 2014 | Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869. | Pharmacy Creations | Drug | Class I | 1 |
| 25 Jun 2014 | Cool Tropics Rips Slush, Sour Apple Flavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL), Contains: Water, Apple Juice Concentrate***Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE" UPC Code 9 76017 00310 1 | Manufacturing Solutions International | Food | Class II | 3 |
| 24 Jun 2014 | ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also… | Brainlab AG | Device | Class II | 1 |
| 24 Jun 2014 | Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 24 Jun 2014 | Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673 (68638) | Doctor's Best, Inc. | Drug | Class II | 1 |
| 23 Jun 2014 | SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 2 |
| 23 Jun 2014 | Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581 | Biomet, Inc. | Device | Class II | 1 |
| 20 Jun 2014 | Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91. | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 20 Jun 2014 | Malt-O-Meal Frosted Flakes, item number 00955, UPC 42400-00955. Net Wt. 2.00oz (56g) (68724) | mom Brands | Food | Class III | 1 |
| 19 Jun 2014 | Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems. | Boston Scientific CRM Corp | Device | Class II | 1 |
| 19 Jun 2014 | 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.… (68617) | Individual firm, name withheld | Device | Class II | 1 |
| 19 Jun 2014 | Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30 | Pfizer Inc. | Drug | Class III | 1 |
| 19 Jun 2014 | Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. By: McKesson Packaging Services a business unit of McKesson Corporation, concord, NC | Mckesson Packaging Services | Drug | Class III | 1 |
| 19 Jun 2014 | Part Skim Ricotta cheese: SYSCO Imperial Ricotta Cheese packaged in 5 pound tubs and Sargento Part-Skim Ricotta Natural Cheese and Miceli's Part-Skim Ricotta Cheese packaged in 15 ounce tubs. | Miceli Dairy Products Co | Food | Class II | 5 |
| 18 Jun 2014 | Frederick Farms 4oz chocolate ice cream cups, net wt. 67grams, 24 per box, 231 boxes per pallet, expiration 6-10-15 (68675) | Garber Ice Cream Company Inc | Food | Class II | 1 |
| 17 Jun 2014 | Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 16 Jun 2014 | Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D | Medtronic MiniMed Inc. | Device | Class II | 1 |
| 13 Jun 2014 | Jody's, Funfetti, Net Wt 7.5 oz (213 g) and 4 oz in clear cellophane bag. | Jody's Inc. | Food | Class II | 3 |
| 12 Jun 2014 | WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463. (68870) | Biolase Technology Inc | Device | Class II | 1 |
| 12 Jun 2014 | FISH FAMILY FARM INC. & & Shadow Valley Farm brand CHOCOLATE MILK GRADE A PASTEURIZED HOMOGENIZED in a glass half-gallon container | Individual firm, name withheld | Food | Class II | 5 |
| 11 Jun 2014 | Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation… (68615) | Individual firm, name withheld | Device | Class II | 1 |
| 10 Jun 2014 | Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures. | Zimmer, Inc. | Device | Class II | 1 |
| 9 Jun 2014 | MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures. | Nidek Inc | Device | Class II | 1 |
| 9 Jun 2014 | Professional Bak-klene All Purpose No-Stick Bakery Spray, packaged in 14-oz. aerosol cans. (68555) | Plaze Inc | Food | Class II | 1 |
| 5 Jun 2014 | Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 4 Jun 2014 | InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156. | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 4 Jun 2014 | DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc. | DeRoyal Industries Inc | Device | Class II | 2 |
| 2 Jun 2014 | EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 2 Jun 2014 | Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6. (68401) | Alexion Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 2 Jun 2014 | Ronzoni Roasted Garlic Fettuccine Net Wt. 12 OZ. Enriched Macaroni Product shelf-stable packed in blue paperboard box all codes (68682) | EBRO North America dba New World Pasta | Food | Class II | 1 |
| 30 May 2014 | KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator. | Carestream Health Inc. | Device | Class II | 1 |
| 28 May 2014 | Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 28 May 2014 | Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape… (68443) | Childrens Medical Ventures | Device | Class I | 1 |
| 27 May 2014 | Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids. | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 24 May 2014 | Mrs. Fields Milk Chocolate Chip Cookies, Net Wt. 8 oz (227 g) cardboard carton with 8 individually wrapped 1 oz cookies. 12 cartons in a case. UPC 8-86002-50651-7. (68544) | Interbake Foods Llc | Food | Class II | 1 |
| 23 May 2014 | CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic… | Cardiovascular Systems, Inc. | Device | Class I | 1 |
| 23 May 2014 | Shelled walnuts, 8 oz., packed in a clear plastic container and sold under the Farmer's Market brand. (68836) | Farmers Market | Food | Class I | 1 |
| 21 May 2014 | Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image… | Brainlab AG | Device | Class II | 1 |
| 21 May 2014 | KIND HEALTHY GRAINS Maple Pumpkin Seed Bar, 35g, packaged in a purple, black and transparent wrapper. Sold individually or packaged in a box of 5. | KIND, LLC | Food | Class I | 6 |
| 19 May 2014 | Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a… (68445) | Small Bone Innovations | Device | Class II | 1 |
| 19 May 2014 | Original Silk Light Soymilk Half Gallon, Distributed by WhiteWave Foods Broomfield, Colorado 80021, UPC 0 25293 60101 7 (68327) | White Wave Foods, Inc | Food | Class I | 1 |
| 16 May 2014 | GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty. | Nidek Inc | Device | Class II | 1 |
| 16 May 2014 | ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588 | US Compounding Inc | Drug | Class II | 1 |
| 15 May 2014 | Traditional Hummus sold under the Archer Farms brand and packaged in either a transparent plastic tub or a white plastic tub with a net weight respectively of 10 oz (283 g) or 2 lb. | Hot Mama's Foods | Food | Class I | 8 |
| 13 May 2014 | Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses. | AGFA Healthcare Corp. | Device | Class III | 1 |
| 13 May 2014 | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs… | AMO Puerto Rico Manufacturing, Inc. | Device | Class II | 17 |
| 12 May 2014 | 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015 | Baxter Healthcare Corp. | Drug | Class I | 1 |
| 9 May 2014 | Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA | Omnilife Science Inc. | Device | Class II | 1 |
| 5 May 2014 | Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. | Mckesson Medical Immaging | Device | Class II | 1 |
| 30 Apr 2014 | Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle, Distributed by: Bacai, INC. www.litefitusa.com (68170) | Bacai Inc. Dba Ky Duyen House | Drug | Class I | 1 |
| 28 Apr 2014 | Beirut Lift Turnips Pickles, Net Wt. 24.66 oz., 700g, Imported & Distributed By: Baroody Import Inc., 1500 B Main Ave. Clifton, NJ 07011, N DC #642036014141 in a sealed glass jar. | Baroody Imports Inc. | Food | Class III | 1 |
| 17 Apr 2014 | Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood… | Nanosphere, Inc. | Device | Class II | 1 |
| 17 Apr 2014 | Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2. (68685) | Trigen Laboratories, Inc. | Drug | Class III | 1 |
| 16 Apr 2014 | DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) | Synthes, Inc. | Device | Class I | 1 |
| 15 Apr 2014 | Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638. UPC: 7 99475 35350 5. (68122) | Individual firm, name withheld | Drug | Class I | 1 |
| 2 Apr 2014 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30 | Hospira Inc. | Drug | Class I | 1 |
| 1 Apr 2014 | triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in… | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 25 Mar 2014 | IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing. (68556) | Wellspring Pharmaceutical Corporation | Device | Class I | 1 |
| 28 Feb 2014 | XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; HOT; NET WT. 11.5 OZ (326g); DIST BY: XOCHITL (so cheel), INC. (214)800-351 DALLAS, TEXAS 75252 | Renfro Foods, Inc. | Food | Class II | 3 |
| 10 Jan 2014 | DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02 | Hospira Inc. | Drug | Class I | 1 |
| 10 Jan 2014 | Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026 | Dermamedics, L.L.C. | Drug | Class II | 9 |
| 11 Dec 2013 | Latex Dental Dams labeled as Non-Latex Dental Dams | Coltene Whaledent Inc | Device | Class II | 1 |
| 20 Nov 2013 | All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013. (67814) | Hyperion Medical | Device | Class II | 1 |
| 16 Oct 2013 | Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene… | Nanosphere, Inc. | Device | Class III | 1 |
| 14 Oct 2013 | VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma. | BioMerieux SA | Device | Class II | 1 |
| 11 Sep 2013 | Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11 | Janssen Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 7 Aug 2013 | Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is… (68596) | Enhancement Medical, LLC | Device | Class I | 1 |
| 10 Jun 2013 | Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L… | Zimmer, Inc. | Device | Class II | 6 |
| 17 Apr 2013 | VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest probability… | BioMerieux SA | Device | Class II | 1 |