| IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) (K142811) | Siemens Healthcare Diagnostics, Inc. | 2014-10-29 |
| AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON (K141912) | Advanced Orthopaedic Solutions, Inc. | 2014-10-29 |
| KUBTEC X250 (K141539) | Kub Technologies, Inc. | 2014-10-29 |
| EpiAccess System (K142245) | Epiep, Inc. | 2014-10-29 |
| UNIVERSAL CLAMP SPINAL FIXATION SYSTEM (K142053) | Zimmer Spine, Inc. | 2014-10-29 |
| LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR (K141221) | Lares Research, Inc. | 2014-10-28 |
| EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX (K142084) | Ncontact Surgical, Inc. | 2014-10-28 |
| EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY (K141686) | Smith Medical Asd, Inc. | 2014-10-28 |
| SMARTGRAFT 200 SYSTEM (K141713) | Ingeneron, Inc. | 2014-10-28 |
| #8C RENEGADE DENTAL HANDPIECE (K142063) | Handpiece Club, LLC | 2014-10-28 |
| HYPERQ ACS-100 SYSTEM (K140020) | Bsp-Biiological Signal Processing, Ltd. | 2014-10-28 |
| APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 (K141459) | Toshibamedical Systems Corporation | 2014-10-28 |
| E-CUBE 12 (K142884) | Alpinion Medical Systems Co., Ltd. | 2014-10-28 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP (K142170) | Becton, Dickinson and Company | 2014-10-28 |
| E-CUBE 5 (K142733) | Alpinion Medical Systems Co., Ltd. | 2014-10-28 |
| Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh (K142900) | Sofradim Production | 2014-10-28 |
| Well Lead PVC Urethral Catheter (K142563) | Well Lead Medical Co., Ltd. | 2014-10-28 |
| Fortrex 0.035 OTW PTA Balloon Catheter (K142654) | Covidien, LLC | 2014-10-28 |
| KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS (K132771) | Qingdao Kingston Medical Devices, Ltd. | 2014-10-28 |
| ALLOX2 TISSUE EXPANDERS (K140383) | Specialty Surgical Products, Inc. | 2014-10-28 |
| ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT (K142082) | Zimmer Dental, Inc. | 2014-10-28 |
| Xia® Growth Rod Conversion Set (K142114) | Stryker Corporation | 2014-10-27 |
| Uroflowmeter (K142425) | Be Technologies, Inc. | 2014-10-27 |
| VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL (K141407) | Biomet, Inc. | 2014-10-27 |
| FLOSPINE PEDICLE SCREW SYSTEM (K141850) | Flospine | 2014-10-27 |
| ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO (K140225) | Phadia US, Inc. | 2014-10-27 |
| PROCESS INDICATOR TAPE FOR STEAM STERILIZATION (K140940) | Canadian Technical Tape, Ltd. | 2014-10-27 |
| CD HORIZON Spinal System (K142847) | Medtronic Sofamor Danck USA, Inc. | 2014-10-27 |
| ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL (K141953) | Titan Spine, LLC | 2014-10-27 |
| BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) (K141331) | Biomet, Inc. | 2014-10-27 |
| RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM (K141809) | Defibtech, LLC | 2014-10-27 |
| FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS (K142070) | Rti Surgical, Inc. | 2014-10-27 |
| E-FIT EF-1280 EMS MACHINE (K133225) | Fit-Pro Kft , Ltd. | 2014-10-24 |
| NEPHROS DSU-H, NEPHROS SSU-H (K141731) | Nephros, Inc. | 2014-10-24 |
| NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT (K140022) | Cork Medical Products, LLC | 2014-10-24 |
| CrossCLIP Implant System (K142727) | Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems | 2014-10-24 |
| CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES (K133069) | Codent Technical Industry Co., Ltd. | 2014-10-24 |
| ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM (K142133) | Roche Diagnostics | 2014-10-24 |
| CLINPRO PROPHY POWDER (K140684) | 3M Deutschland GmbH | 2014-10-24 |
| STALIF CTI, STALIF C (K142079) | Centinel Spine, Inc. | 2014-10-24 |
| OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS (K141759) | Oak Ridge Products, LLC | 2014-10-24 |
| OPTON PRO (K141564) | Zimmer Medizinsystems GmbH | 2014-10-24 |
| PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM (K141714) | Wrightmedicaltechnologyinc | 2014-10-24 |
| RENOVOCATH RC120 (K141175) | Renovorx, Inc. | 2014-10-24 |
| XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) (K140647) | Luminex Molecular Diagnostics, Inc. | 2014-10-24 |
| 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, (K142574) | Depuy Mitek, A Johnson & Johnson Company | 2014-10-24 |
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface (K142784) | Medtronic, Inc. | 2014-10-24 |
| UNIVERSAL NAVIGATION INSTRUMENTS (K140927) | Medos International SARL | 2014-10-24 |
| LiNA PowerBlade Plus HC (K142757) | Lina Medical Aps | 2014-10-23 |
| PerkinElmer, XRpad 4343 F MED Flat Panel Detector (K142698) | Perkinelmer, Inc. | 2014-10-23 |
| HEMOPORE (K141816) | Polyganics B.V., | 2014-10-23 |
| TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA (K141325) | Topcon Corp. | 2014-10-23 |
| Vasc Band hemostat (K142359) | Lepu Medical Technology (Beijing) Co., Ltd. | 2014-10-23 |
| Flexible Video-Uretero-Choledochoscope System (K142556) | KARL STORZ Endoscopy-America, Inc. | 2014-10-23 |
| U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE (K141125) | Handpiece Headquarters | 2014-10-23 |
| TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 (K133157) | Medtronic, Inc. | 2014-10-23 |
| Siemens 3.0 Blanket Array Coil (K142755) | Resonance Innovations, LLC | 2014-10-23 |
| PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM (K140205) | Teleflexmedical, Inc. | 2014-10-23 |
| SUPERNOVA C5 MRI SYSTEM (K131737) | Liaoning Kampo Medical System Co., Ltd. | 2014-10-23 |
| ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems (K142876) | Siemens Medical Solutions USA, Inc. | 2014-10-23 |
| RAYSTATION (K141860) | Raysearch Laboratories AB | 2014-10-23 |
| COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM (K140754) | CooperSurgical, Inc. | 2014-10-23 |
| ABACUS (TM) SPACER SYSTEM (K142101) | Spine Wave, Inc. | 2014-10-23 |
| ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE (K141339) | Asahi Intecc Co., Ltd. | 2014-10-23 |
| ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE (K141560) | ETHICON, Inc. | 2014-10-23 |
| Stryker Precision HD Camera System (K142603) | Stryker Endoscopy | 2014-10-23 |
| SOLITAIRE 2 REVASCULARIZATION DEVICE (K141491) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014-10-22 |
| VALOR Hindfoot Fusion Nail System (K142602) | Wrightmedicaltechnologyinc | 2014-10-22 |
| Zimmer Periarticular Plating System (K142579) | Zimmer, Inc. | 2014-10-22 |
| ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM (K142281) | Zimmer, Inc. | 2014-10-22 |
| Ultra Silver Dressings (K141603) | Milliken Healthcare Products, LLC | 2014-10-22 |
| INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS (K141211) | Prismatik Dentalcraft, Inc. | 2014-10-22 |
| UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK (K141724) | Liaoning Upcera Co., Ltd. | 2014-10-22 |
| ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM (K141544) | Zimmer Dental, Inc. | 2014-10-22 |
| UNIVERSAL DIGITAL INTERFACE 2, UDI 2 (K140251) | Meridian Medical Systems, LLC | 2014-10-22 |
| VERADIUS UNITY (K142708) | Philips Medical Systems Nethrlands BV | 2014-10-22 |
| DUAL SWITCH (K141908) | Laser Engineering, Inc. | 2014-10-22 |
| VANTERA CLINICAL ANALYZER (K133849) | Liposcience | 2014-10-22 |
| UPCERA COLORING LIQUID (I AND II ) (K141723) | Liaoning Upcera Co., Ltd. | 2014-10-22 |
| Vericore Zirconia Blanks (K142670) | Whip Mix Corporation | 2014-10-22 |
| LIGHT SCALPEL (K141658) | Lightscalpel, LLC | 2014-10-22 |
| VIORA V-TOUCH (K141904) | Viora , Ltd. | 2014-10-21 |
| FDR D-EVO II FLAT PANEL DETECTOR SYSTEM (K142003) | Fujifilm Medical System U.S.A., Inc. | 2014-10-21 |
| CD HORIZON SPINAL SYSTEM (K141604) | Medtronic Sofamor Danek USA, Inc. | 2014-10-21 |
| ERCHONIA SHL (K142042) | Erchonia Corporation | 2014-10-21 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |
| Xia 3 Spinal System (K142381) | Stryker Corp. | 2014-10-21 |
| SENSITITRE SUSCEPTIBILITY PLATES (K141651) | Thermo Fisher Scientific | 2014-10-21 |
| PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM (K140197) | Teleflexmedical, Inc. | 2014-10-21 |
| IONOSTAR MOLAR (K140993) | Voco GmbH | 2014-10-20 |
| SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (K142026) | Spinefrontier, Inc. | 2014-10-20 |
| SIMPLE T YOUTH NASAL MASK (K140268) | Respironics, Inc. | 2014-10-20 |
| AILERON INTERSPINOUS FIXATION SYSTEM (K140236) | Life Spine, Inc. | 2014-10-20 |
| SKORE AND MULTIPLE BRANDS (K132490) | Ttk Protective Devices Limited (Formerly Ttk-Lig L | 2014-10-20 |
| MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR (K140728) | Ditron Precision, Ltd. | 2014-10-17 |
| EXPEL APD DRAINAGE CATHETER SYSTEM (K141335) | Boston Scientific Corp | 2014-10-17 |
| NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT (K141600) | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014-10-17 |
| ARDO CARUM AND CALYPSO POWERED BREAST PUMPS (K141742) | Ardo Medical AG | 2014-10-17 |
| Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) (K142220) | Nova Biomedical Corporation | 2014-10-17 |
| Antegrade LeMills Valvulotome (K142660) | LeMaitre Vascular, Inc. | 2014-10-17 |