| FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM (K122379) | Ostial Corporation | 2012-09-05 |
| MOLLRING MULTITASC (K121415) | LeMaitre Vascular, Inc. | 2012-09-05 |
| METS SMILES TOTAL KNEE REPLACEMENT (K120992) | Stanmore Implants Worldwide , Ltd. | 2012-09-05 |
| TIXOS IMPLANT SYSTEM (K120792) | Leader Italia S.R.L. | 2012-09-05 |
| LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER (K113572) | Covidien, Formerly Valleylab, A Division of Tyco H | 2012-09-05 |
| STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM (K121893) | Stryker Endoscopy | 2012-09-05 |
| TERUMO SURFLASH SAFETY I.V. CATHETER (K122544) | Terumo Corporation | 2012-09-05 |
| RELIANCE ANTERIOR CERVICAL PLATE SYSTEM (K122216) | Reliance Medical Systems, LLC | 2012-09-05 |
| UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM (K122583) | Samsung Medison Co., Ltd. | 2012-09-05 |
| TEST, BLOOD GLUCOSE SYSTEM (K120064) | Hmd Biomedical, Inc. | 2012-09-05 |
| AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION (K121654) | I-Sens, Inc. | 2012-09-05 |
| TENS BACK PAIN RELIEF SYSTEM (K113321) | Savia Limited | 2012-09-04 |
| IOI TOTAL HIP (K121034) | Iconacy Orthopedic Implants, LLC | 2012-09-04 |
| ORTHOFIX GALAXY FIXATION SYSTEM (K113770) | Orthofix Srl | 2012-09-04 |
| CVINSIGHT (K120052) | Intelomed, Inc. | 2012-09-04 |
| CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES (K122042) | Mauna Kea Technologies | 2012-09-04 |
| ALAMO P (K122047) | Alliance Partners, LLC | 2012-09-04 |
| PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K122155) | VATECH Co., Ltd. | 2012-09-04 |
| ARC ENDOCUFF (K122565) | Boddingtons Plastics, Ltd. | 2012-09-04 |
| PINTLER PATIENT WARMING SYSTEM (K113705) | Pintler Medical | 2012-08-31 |
| TYSHAK NUCLEUS (K121859) | NuMED, Inc. | 2012-08-31 |
| FLEXLAB 3.6, ACCELERATOR A3600 (K121012) | Inpeco S.P.A. | 2012-08-31 |
| STALIF C (K120819) | Centinel Spine, Inc. | 2012-08-31 |
| DACRYOCATH (K113508) | Armadillo Biomedical, LLC | 2012-08-31 |
| DISPOSABLE HEMOSTASIS CHIP (K121505) | Wilson-Cook Medical Inc./Cook Endoscopy | 2012-08-31 |
| EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) (K121196) | Boston Scientific Corp | 2012-08-31 |
| THERMO SCIENTIFIC MAS OMNI-CARDIO (K122291) | Microgenics Corporation | 2012-08-31 |
| LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T (K113652) | Aap Implantate AG | 2012-08-30 |
| VANTERA CLINICAL ANALYZER (K113830) | Liposcience | 2012-08-30 |
| PRECISE SHP DIODE LASER (K113472) | CAO Group, Inc. | 2012-08-30 |
| THIXO-GEL ULTRASOUND SPRAY (K121311) | Cloverline International Pharma Services GmbH | 2012-08-30 |
| DTAD (K121678) | Gyrus Acmi, Inc. | 2012-08-30 |
| CRAINFIX 2 TITANIUM CLAMP SYSTEM (K122353) | Aesculap, Inc. | 2012-08-30 |
| HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS (K122066) | The Binding Site Group , Ltd. | 2012-08-30 |
| PROTURA COUCH SOFTWARE (K122201) | Med-Tec, Inc. D/B/A Civco Medical Solutions | 2012-08-30 |
| ZIMMER DENTAL TAPERED SCREW-VENT X (K113753) | Zimmer Dental, Inc. | 2012-08-30 |
| SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300 (K113291) | Simex Medizintechnik GmbH | 2012-08-30 |
| RUBICON 18 SUPPORT CATHETER (K122394) | Boston Scientific Corp | 2012-08-30 |
| CERVICAL CAGE (K122444) | Eisertech, LLC | 2012-08-30 |
| SMARTLYTE ELECTROLYTE ANALYZER (K121040) | Diamond Diagnostics, Inc. | 2012-08-30 |
| TOMOTHERAPY TREATMENT SYSTEM (K121934) | Accuray Incorporated | 2012-08-29 |
| INTRODUCER SET, MODEL ADELANTE-S SERIES (K122084) | Oscor, Inc. | 2012-08-29 |
| NEURO VENTION LAMINPLASTY PLATING SYSTEM (K121276) | Neurovention, LLC | 2012-08-29 |
| AZUR DETACHABLE 35 (K122316) | MicroVention, Inc. | 2012-08-29 |
| INTELLIVUE PATIENT MONITOR (K122439) | Philips Medizin Systeme Boeblingen GmbH | 2012-08-29 |
| PADNET 2.0 (K122281) | Biomedix, Inc. | 2012-08-29 |
| STAXX XD SYSTEM (K121889) | Spine Wave, Inc. | 2012-08-29 |
| TETRIS II (K122317) | Signus Medizintechnik GmbH | 2012-08-29 |
| ARTISAN EXTEND CONTROL CATHETER (K122275) | Hansen Medical | 2012-08-29 |
| CAPSTONE SPINAL SYSTEM (K121760) | Medtronic Sofamor Danek USA, Inc. | 2012-08-29 |
| IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE (K121230) | Ivoclar Vivadent, AG | 2012-08-29 |
| ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP (K122276) | AtriCure, Inc. | 2012-08-29 |
| SINUS DILATION SYSTEM (K121351) | Entrigue Surgical, Inc. | 2012-08-29 |
| HEM-7200-Z (BP742) (K121932) | Omron Healthcare, Inc. | 2012-08-29 |
| INFILL GRAFT DELIVERY SYSTEM (K121476) | Pinnacle Spine Group, LLC | 2012-08-29 |
| TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE (K122249) | Terumo (Philippines) Corporation | 2012-08-28 |
| VITEK 2 STRPTOCOCCUS CEFTRIAXONE (K122359) | bioMerieux, Inc. | 2012-08-28 |
| FDR GO FLEX (K120629) | Fujifilm Medical System U.S.A., Inc. | 2012-08-28 |
| KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) (K120246) | Carestream Health, Inc. | 2012-08-28 |
| PMMA CAD/CAM DISC (K112967) | Polident D.O.O., Dental Products Industry | 2012-08-28 |
| XIA 3 SPINAL SYSTEM (K113666) | Stryker Spine | 2012-08-28 |
| AIXPLORER (K112255) | Supersonic Imagine | 2012-08-28 |
| ENLUXTRA HUMIFIBER WOUND DRESSING (K122297) | Basf Venture Capital America, Inc. | 2012-08-28 |
| ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK (K121251) | Galil Medical , Ltd. | 2012-08-28 |
| PAX-UNI3D, PHT-7500 (K121400) | VATECH Co., Ltd. | 2012-08-28 |
| ULTHERA SYSTEM (K122528) | Ulthera, Inc. | 2012-08-28 |
| ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER (K122027) | Arrow International, Inc. | 2012-08-28 |
| LARYNGEAL ELECTRODE (K121257) | Technomed Europe | 2012-08-28 |
| CATALYS PRECISION LASER SYSTEM (K121091) | Optimedica Corporation | 2012-08-28 |
| SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING (K122296) | Smith & Nephew, Inc. | 2012-08-28 |
| INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY (K121482) | Theken Spine, LLC | 2012-08-28 |
| DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI (K122323) | Siemens Healthcare Diagnostics | 2012-08-28 |
| TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE (K121264) | Medtronic Surgical Technologies | 2012-08-27 |
| BAROSTAT SOFTWARE OPTION (K120997) | Crospon, Ltd. | 2012-08-27 |
| ACE MAGNESIUM REGENT (K122302) | Alfa Wassermann Diagnostics Technologies, LLC | 2012-08-27 |
| PICIS WEIGHT BASED DOSE CONVERTER (K121542) | Picis, Inc. | 2012-08-27 |
| ARJORAD STERILE WRAP (K110954) | Arjo Wiggins Medical, Inc. | 2012-08-24 |
| INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT (K120169) | Grifols USA, LLC | 2012-08-24 |
| LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S (K121103) | Ldr Spine USA, Inc. | 2012-08-24 |
| AIXPLORER (K121329) | Supersonic Imagine | 2012-08-24 |
| PHANTOM PLUS CERAMIC CAGE SYSTEM (K121892) | Amedica Corp. | 2012-08-24 |
| ELEVANCE (K120239) | Midmark | 2012-08-24 |
| INWAVE (K121820) | Zynex Medical, Inc. | 2012-08-24 |
| INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR (K122254) | Sorin Group Italia S.R.L. | 2012-08-24 |
| RANDOX OPIATES ASSAY (K113747) | Randox Laboratories Limited | 2012-08-24 |
| ZIMMER TRABECULAR METAL TOTAL ANKLE (K120906) | Zimmer, Inc. | 2012-08-24 |
| NUVASIVE POLYAXIAL SPINAL SCREWS (K121619) | Nuvasive, Inc. | 2012-08-24 |
| ELECSYS HSV-2 IGG IMMUNOASSAY (K121895) | Roche Diagnostics | 2012-08-24 |
| (MULTIPLE) DIGITAL THERMOMETER (K120004) | China Shenyang Med-Land Imp/Exp Corp., Ltd. | 2012-08-23 |
| ERCHONIA ZERONA (K121695) | Erchonia Corporation | 2012-08-23 |
| FREEDOM INGUINAL HERNIA IMPLANT (K113552) | Insightra Medical | 2012-08-23 |
| LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM (K111603) | Ep Dynamics, Inc. | 2012-08-23 |
| ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 (K121824) | Lascod Spa | 2012-08-23 |
| SYNTHES CURVILINEAR DISTRACTION SYSTEM (K121502) | Synthes, Inc. | 2012-08-23 |
| NMI PICC III (K121089) | Navilyst Medical, Inc. | 2012-08-23 |
| THERMAL LIGATING SHEARS (K122086) | Microline Surgical, Inc. | 2012-08-23 |
| AVT NATURASOFT (K121324) | Advanced Vision Technologies | 2012-08-23 |
| ETCHONIA ZERONA ARMS (K121690) | Erchonia Corporation | 2012-08-23 |
| AMPLATZER TORQVUE FX (K121611) | Aga Medical Corporation | 2012-08-23 |
| TRANS1 INTERBODY FUSION SYSTEM (K120991) | Trans1 Incorporated | 2012-08-23 |