| GMK EXTENSION (K142069) | Medacta International | 2014-12-02 |
| Skintact, various other tradenames (K142803) | Leonhard Lang GmbH | 2014-12-02 |
| Stryker Infrared Fluorescence (IRF) Imaging System (K142310) | Stryker Endoscopy | 2014-12-02 |
| PGS 5.5 MM CANNULATED PEDICLE SCREW (K141282) | Pinnacle Spine Group | 2014-12-02 |
| ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set (K143164) | Kimberly-Clark Corporation | 2014-12-02 |
| Infrared Therapy System (K142340) | Beijing Huatai Healthcare Technology Co., Ltd. | 2014-12-02 |
| HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE (K141862) | H2, Inc. | 2014-12-02 |
| CLEARLUMEN THROMBECTOMY SYSTEM (K140296) | Walk Vascular, LLC | 2014-12-02 |
| Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip (K142471) | Pressure Point, Inc. | 2014-12-01 |
| SIVR56-T KIT (K133994) | Barco N.V. | 2014-12-01 |
| HairMax LaserComb, HairMax LaserComb (K142573) | Lexington International, LLC | 2014-12-01 |
| BP652N (HEM-6300-Z) (K142917) | Omron Healthcare, Inc. | 2014-12-01 |
| CD HORIZON Spinal System (K143141) | Medtronic Sofamor Danek USA, Inc. | 2014-12-01 |
| JULIET LL (K141135) | Spineart | 2014-12-01 |
| CD HORIZON Spinal System (K142591) | Medtronic Sofamor Danek USA, Inc. | 2014-12-01 |
| AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz (K142285) | Ameriwater | 2014-12-01 |
| Synapse 3D Liver and Kidney Analysis (K142521) | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014-12-01 |
| Chemtrue Multi-Panel DOA DIP Card Tests (K142580) | Chemtron Biotech, Inc. | 2014-12-01 |
| Resolution Clip (K142973) | Boston Scientific Corporation | 2014-12-01 |
| ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM (K140041) | Genoray Co., Ltd. | 2014-11-28 |
| Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers (K143066) | Zimmer, Inc. | 2014-11-28 |
| nva, nvp, nvt (K142594) | Nvision Biomedical Technologies, LLC | 2014-11-28 |
| APEX (K141158) | Incontrol Medical, LLC | 2014-11-26 |
| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM (K142029) | Hologic, Inc. | 2014-11-26 |
| DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT (K140859) | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 |
| HEARTFLOW FFRCT (DEN130045) | Heartflow | 2014-11-26 |
| DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART (K140842) | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 |
| RESOLVE BILIARY LOCKING DRAINAGE CATHETER (K141408) | Merit Medical Systems, Inc. | 2014-11-26 |
| AQUILION PRIME, V6.00 (K141741) | Toshibamedical Systems Corporation | 2014-11-26 |
| Surgisleeve Wound Protector (K143091) | Covidien, LLC | 2014-11-26 |
| Cytosponge Cell Collection Device (K142695) | Covidien, LLC | 2014-11-26 |
| Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K142501) | Cepheid | 2014-11-26 |
| WS80A Diagnostic Ultrasound System (K143089) | Samsung Medison Co., Ltd. | 2014-11-26 |
| SYMETREX LONG TERM HEMODIALYSIS CATHETER (K140884) | Phase One Medical | 2014-11-26 |
| GENESIS II (K133434) | Dornier Medtech America, Inc. | 2014-11-26 |
| G3 Active Plate Large Fragment System (K142938) | Genesis Fracture Care, Inc. | 2014-11-26 |
| Univers Rivers Shoulder Prosthesis System (K142863) | Arthrex, Inc. | 2014-11-25 |
| GENESIS TOUCH SYSTEM (K141792) | Honeywell Hommed | 2014-11-25 |
| PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 (K140535) | Philips Medizin Systeme Boblingen GmbH | 2014-11-25 |
| ALLY UPS (K141523) | CooperSurgical, Inc. | 2014-11-25 |
| ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY (K141231) | Zeller Power Products (Battery Beast, LLC) | 2014-11-25 |
| AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM (K133989) | Mortara Instrument, Inc. | 2014-11-25 |
| SNaP Wound Care System (K142272) | Spiracur, Inc. | 2014-11-25 |
| AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY (K140382) | Merit Medical Systems, Inc. | 2014-11-25 |
| DR300 HOLTER MONITOR (K142424) | North East Monitoring, Inc. | 2014-11-25 |
| ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (K141333) | Spinefrontier, Inc. | 2014-11-25 |
| Masimo Root Monitoring System and Accesories (K142394) | Masimo Corporation | 2014-11-25 |
| COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR (K141928) | Roche Diagnostics Operations (Rdo) | 2014-11-25 |
| PREDICATE III GUIDEWIRE (K142393) | Lake Region Medical | 2014-11-25 |
| Atricure Cryo Module System; cryoICE cryoablation probe (K142203) | AtriCure, Inc. | 2014-11-25 |
| CoRoent Small Interlock System (K142299) | Nu Vasive, Incorporated | 2014-11-25 |
| TURNPIKE CATHETER (K142065) | Vascular Solutions, Inc. | 2014-11-25 |
| Sherpa Pak Cardiac Transport System (K143074) | Paragonix Technologies, Inc. | 2014-11-25 |
| TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT (K140768) | Lepu Medical Technology (Bejing) Co., Ltd. | 2014-11-25 |
| Variolink Esthetic (K142389) | Ivoclar Vivadent, AG | 2014-11-25 |
| Hospira Primary Sets (K142367) | Hospira, Inc. | 2014-11-25 |
| LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE (K142270) | Hartalega Sdb. Bhd. | 2014-11-25 |
| INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE (K142118) | Prismatik Dentalcraft, Inc. | 2014-11-25 |
| IN:C2 SPINAL FIXATION SYSTME (K141537) | Spine Smith Holdings, LLC | 2014-11-25 |
| Sherpa Pak Kidney Transport System (K143054) | Paragonix Technologies, Inc. | 2014-11-25 |
| VASCU-GUARD Peripheral Vascular Patch (K142461) | Synovis Life Technologies, Inc. | 2014-11-25 |
| TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET (K141939) | Teleflexmedical, Inc. | 2014-11-24 |
| SIGNA PET/MR (K142098) | Ge Medical Systems, LLC | 2014-11-24 |
| MAYFIELD Skull Clamp (K142238) | Integra LifeSciences Corporation | 2014-11-24 |
| OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE (K140716) | Interventional Spine, Inc. | 2014-11-24 |
| KangLi pedical screw spinal system (K142290) | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014-11-24 |
| Collagen Dental Membrane - Conformable IIBP (K142496) | Collagen Matrix, Inc. | 2014-11-24 |
| WOUNDCLOT HEMOSTATIC GAUZE (K140573) | Core Scientific , Ltd. | 2014-11-24 |
| CONCHASMART COLUMN (K141940) | Teleflex, Inc. | 2014-11-24 |
| ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED (K141952) | Ethicon Endo-Surgery, Inc. | 2014-11-24 |
| HUMICARE D900 (K133766) | Gruendler GmbH | 2014-11-24 |
| TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (K141682) | Infraredx, Inc. | 2014-11-24 |
| Atlas SPEEDER Head/Neck (K142802) | Quality Electrodynamics, LLC | 2014-11-24 |
| IntelAir Nasal Airway Support System (K142467) | Abeon Medical Corporation | 2014-11-24 |
| Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System (K142403) | Zimmer GmbH | 2014-11-24 |
| GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) (K142072) | Custom Orthopaedic Solutions, Inc. | 2014-11-24 |
| EEVA SYSTEM (K142147) | Auxogyn, Inc. | 2014-11-24 |
| SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE (K140566) | Crosstex International | 2014-11-24 |
| XPERT FLU/RSV XC ASSAY (K142045) | Cepheid | 2014-11-22 |
| SUDOSCAN (K141872) | Impeto Medical, Inc. | 2014-11-21 |
| ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 (K142197) | Konica Minolta, Inc. | 2014-11-21 |
| STIM PROBE (K133348) | Spes Medica Srl | 2014-11-21 |
| DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE (K134006) | Modern Medical Equipment Manufacturing Limited | 2014-11-21 |
| VEGA Knee System (K143106) | Aesculap Implant Systems, LLC | 2014-11-21 |
| LG SMARTHEALTH (K133997) | Lg Electronics | 2014-11-21 |
| PK Lap Loop (K142525) | Olympus Winter & Ibe GmbH | 2014-11-21 |
| SGS DENTAL IMPLANT (K133362) | Sgs International, Ltd. | 2014-11-21 |
| GLIDESHEATH SLENDER (K142183) | Terumo Medical Corporation | 2014-11-21 |
| PHILIPS IQON SPECTRAL CT (K133674) | Philips Healthcare (Cleveland) | 2014-11-21 |
| ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 (K142434) | Siemens Medical Solutions USA, Inc. | 2014-11-21 |
| 2.3MP Color LCD Monitor, RadiForce MX242W (K143261) | Eizo Corporation | 2014-11-21 |
| 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin (K142868) | Purple Surgical International Limited | 2014-11-21 |
| Lesion-Loc Iodine I-125 Seed/Needle (K142668) | Intramedical Imaging, LLC | 2014-11-21 |
| BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD (K141377) | Merete Medical GmbH | 2014-11-21 |
| ZEUS (ZIO ECG Utilization Service) System (K142681) | iRhythm Technologies, Inc. | 2014-11-21 |
| Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity (K143026) | Aalto Scientific, Ltd. | 2014-11-21 |
| LUNA INTERBODY SYSTEM (K142023) | Benvenue Medical, Inc. | 2014-11-20 |
| AIXPLORER (K142100) | Supersonic Imagine | 2014-11-20 |
| SPIRAL FLOW PERIPHERAL VASCULAR GRAFT (K142062) | Vascular Flow Technologies, Ltd. | 2014-11-20 |
| Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software (K142520) | Smith & Nephew, Inc. | 2014-11-20 |