| BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY (K132097) | Best Medical International, Inc. | 2013-09-30 |
| WIRED MOUTH PROTECTOR (WMP) (K131396) | Elba Laboratories, Inc. | 2013-09-30 |
| ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC (K131845) | Acumed, LLC | 2013-09-30 |
| MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES (K131559) | Materialise NV | 2013-09-27 |
| MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR (K132369) | Hansen Medical, Inc. | 2013-09-27 |
| THEYFIT MALE CONDOM (K122219) | Theyfit | 2013-09-27 |
| MASTERTORQUE LUX 8900 L (K130560) | Kaltenbach & Voigt GmbH | 2013-09-27 |
| NMI COAXIAL MICROINTRODUCER SET (K132713) | Navilyst Medical, Inc. | 2013-09-27 |
| WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) (K132630) | Guangzhou Wondfo Biotech Co., Ltd. | 2013-09-27 |
| MORCELLEX SIGMA GENERATOR (K131656) | ETHICON, Inc. | 2013-09-27 |
| EXTRICARE 100CC/ 250CC/ 400CC CANISTERS (K132252) | Devon Medical | 2013-09-27 |
| VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING (K131860) | Us Vascular, LLC | 2013-09-27 |
| MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING (K132030) | Medtronic, Inc. | 2013-09-27 |
| LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST (K131618) | Terumo Cardiovascular Systems Corporation | 2013-09-27 |
| VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM (K132659) | Volcano Corporation | 2013-09-27 |
| EASY-GRAFT (K131385) | Degradable Solutions AG | 2013-09-27 |
| TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR (K132696) | GE Healthcare Finland Oy | 2013-09-27 |
| KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET (K123822) | Hk Surgical, Inc. | 2013-09-27 |
| TRINITY ACETABULAR SYSTEM (K131647) | Corin USA | 2013-09-27 |
| STRYKER NAV3I PLATFORM (K130874) | Stryker Corporate | 2013-09-27 |
| COOK CERVICAL RIPENING BALLOON (K131206) | Cook, Inc. | 2013-09-27 |
| ARTHREX UNIVERS APEX (K131633) | Arthrex, Inc. | 2013-09-27 |
| BESTFIT2 NASAL MASK (K130663) | Curative Medical, Inc. | 2013-09-27 |
| PHILIPS DXL 12/16-LEAD ECG ALGORITHM (K132068) | Philips Medical Systems | 2013-09-26 |
| COSEAL (K131411) | Jilin Coronado Medical , Ltd. | 2013-09-26 |
| PERIMETER INTERBODY FUSION DEVICE (K132700) | Medtronic Sofamor Danek, Inc. | 2013-09-26 |
| AIRO CT SYSTEM (K131431) | Mobius Imaging, LLC | 2013-09-26 |
| QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST (K130275) | Tianjin New Bay Bioresearch Co., Ltd. | 2013-09-26 |
| NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS (K131795) | Orfit Industries NV | 2013-09-26 |
| TCM MASSAGER (K130150) | Anhui Jinjianqiao Med-Tech Co,. , Ltd. | 2013-09-26 |
| ESTEYA (K132092) | Nucletron B.V. | 2013-09-26 |
| GENII ARC SMART ARGON PROBE (K130983) | Genii, Inc. | 2013-09-26 |
| TRANSCEND HEATED HUMIDIFIER (K131388) | Somnetics International, Inc. | 2013-09-26 |
| PRECISION ONE LIFECARE; DETECTO; DETECTO (K130952) | Precision One Lifecare, Ltd. | 2013-09-26 |
| ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM (K132654) | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013-09-26 |
| CG+ ARROW JACC POWERED BY ARROW VPS STYLET (K132133) | Arrow International (Subsidiary of Teleflex Inc.) | 2013-09-26 |
| PRIMI SUPPORT CATHETER (K132701) | Thermopeutix, Inc. | 2013-09-26 |
| COCHLEAR BAHA 4 SOUND PROCESSOR (K132278) | Cochlear Americas | 2013-09-26 |
| CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR (K122370) | Bayer Healthcare | 2013-09-26 |
| PROTURA COUCH SOFTWARE (K132084) | Med-Tec, Inc. D/B/A Civco Medical Solutions | 2013-09-26 |
| LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM (K124043) | Lightmed Corp. | 2013-09-26 |
| NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER (K132777) | Ev3, Inc. | 2013-09-26 |
| VIRTUOSO SYSTEM FOR IHC HER2 (4B5) (K121516) | Ventana Medical Systems, Inc. | 2013-09-26 |
| SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) (K131885) | GE Medical Systems SCS | 2013-09-26 |
| I-GEN (K131289) | Megagen Implant Co., Ltd. | 2013-09-25 |
| ECLIPSE TREATMENT PLANNING SYSTEM (K131891) | Varian Medical Systems, Inc. | 2013-09-25 |
| FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES (K131751) | Lucenxia Prescience AG | 2013-09-25 |
| NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) (K131873) | MethodSense, Inc. | 2013-09-25 |
| MULTICHEM P (K131992) | Techno-Path Manufacturing , Ltd. | 2013-09-25 |
| 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES (K130455) | Dentalez Group, Stardental Division | 2013-09-25 |
| ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (K121790) | Beckman Coulter, Inc. | 2013-09-25 |
| ARTHREX COMPRESSION PLATES (K130510) | Arthrex, Inc. | 2013-09-25 |
| PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC (K132665) | Ellman International, Inc. | 2013-09-25 |
| XVI R5.0 (K131965) | Elekta Limited | 2013-09-25 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE (K131440) | Hebei Hongsen Plastics Technology Co, Ltd. | 2013-09-25 |
| JAZZ SYSTEM (K132287) | Hogan Lovells US LLP | 2013-09-25 |
| SHENGGUANG MANUAL WHEELCHAIR (K131529) | Pingdingshan Shenxing Healthcare Technology Co., L | 2013-09-24 |
| AIXPLORER (K132171) | Supersonic Imagine | 2013-09-24 |
| VOLUSON I/E (K131937) | GE Healthcare | 2013-09-24 |
| BRILLIANCE ICT (K131773) | Philips Healthcare (Cleveland) | 2013-09-24 |
| DIAGNOCAM (K123402) | Kaltenbach & Voigt GmbH | 2013-09-24 |
| AIXPLORER (K132274) | Supersonic Imagine | 2013-09-24 |
| GE ECHOPAC (K131685) | Ge Vingmed Ultrasound AS | 2013-09-24 |
| CRYSTAL ULTRA (K130654) | Dental Laboratory Milling Supplies, LLC (Dlms) | 2013-09-24 |
| X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER (K130365) | Encore Medical L.P. | 2013-09-23 |
| SFI-BAR (K131526) | Cendres & Metaux SA | 2013-09-23 |
| ANATOMIC PEEK CERVICAL FUSION SYSTEM (K130177) | Medtronic Sofamor Danek USA, Inc. | 2013-09-23 |
| BELIMED STEAM STERILIZER MST-V (K130172) | Belimed, Inc. | 2013-09-23 |
| EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER (K132672) | Dornier Medtech America | 2013-09-23 |
| RELIANCE CERVICAL IBF SYSTEM (K131429) | Reliance Medical Systems, LLC | 2013-09-23 |
| T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE (K131888) | Medtronic Sofamor Danek, Inc. | 2013-09-23 |
| PIPELINE KNEE SYSTEM (K132046) | Pipeline Orthopedics | 2013-09-23 |
| DESARA MESH, DESARA BLUE (K132069) | Caldera Medical, Inc. | 2013-09-23 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K132692) | Becton, Dickinson and Company | 2013-09-23 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K132508) | Centers for Disease Control and Prevention | 2013-09-23 |
| MULTICHEM WBT (K132174) | Techno-Path Manufacturing , Ltd. | 2013-09-20 |
| PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA (K132203) | Lexion Medical, LLC | 2013-09-20 |
| MROZ REVERSE OSMOSIS SYSTEM (K131622) | Ameriwater | 2013-09-20 |
| MULTICHEM IA AND IA PLUS (K132091) | Techno-Path Manufacturing , Ltd. | 2013-09-20 |
| IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL (K132391) | Siemens Helathcare Diagnostics, Inc. | 2013-09-20 |
| MICROPLEX COIL SYSTEM (MCS), VFC (K132317) | MicroVention, Inc. | 2013-09-20 |
| SINUFLUSH LAVAGE SYSTEM (K131177) | Hedgepath, LLC | 2013-09-20 |
| COROENT SINGLE TAB SYSTEM (K131723) | Nuvasive, Inc. | 2013-09-20 |
| WINGMAN EXTENDABLE TIP SUPPORT CATHETER (K132420) | Reflow Medical | 2013-09-19 |
| AUTOLAP SYSTEM (K131375) | Mst - Medical Surgery Technologies , Ltd. | 2013-09-19 |
| Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER (K132513) | ArthroCare Corporation | 2013-09-19 |
| OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 (K132479) | Interventional Spine, Inc. | 2013-09-19 |
| PHILIPS HERCEPTEST DIGITAL SCORE (K130021) | Philips Medical Systems Nederland B.V. | 2013-09-19 |
| APD LUER-LOCK ADAPTER (K124024) | Fresensius Medical Care North America | 2013-09-19 |
| ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM (K130810) | Zimmer, Inc. | 2013-09-19 |
| BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI (K130053) | Bio-Rad Laboratories, Inc. | 2013-09-19 |
| PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) (K132626) | Pipeline Biotechnology | 2013-09-19 |
| RENOVIS BIPOLAR HIP SYSTEM (K131354) | Renovis Surgical Technologies, LLC | 2013-09-19 |
| VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER (K122143) | Ventana Medical Systems, Inc. | 2013-09-19 |
| TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES (K132632) | Tornier, Inc. | 2013-09-19 |
| EQUINOX CO2 LASER (K131903) | Eclipse Aesthetics, LLC | 2013-09-19 |
| LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU (K132644) | Corentec Co., Ltd. | 2013-09-19 |
| S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K131122) | Renovis Surgical Technologies, LLC | 2013-09-18 |
| NAVIOS FLOW CYTOMETER SYSTEM (K130373) | Beckman Coulter, Inc. | 2013-09-18 |
| GC-3000E DIGITAL COLPOSCOPE (K122311) | Shenzhen Goldcare Meditech Co., Ltd. | 2013-09-18 |