| POLARCUP DUAL MOBILITY SYSTEM (K122244) | Smith & Nephew, Inc. | 2012-08-23 |
| PROLYTE ELECTROLYTE ANALYZER (K121140) | Diamond Diagnostics, Inc. | 2012-08-22 |
| XPRESS MULTI-SINUS DILATION TOOL (K121943) | Entellus Medical, Inc. | 2012-08-22 |
| GENESYS PRESSFT SUTURE ANCHOR (K121890) | Linvatec Corporation D/B/A Conmed Linvatec | 2012-08-22 |
| EON CALCIUM REGENT (K120626) | Vital Diagnostics (Manufacturing) Ptyltd | 2012-08-22 |
| SYSTEM, X-RAY, STATIONARY (K121854) | Beijing Sinopharm Hundric Mediline Info. Tech. Co. | 2012-08-22 |
| EDWARDS PERCUTANEOUS SHEATH INTRODUCER (K121185) | Edwards Lifesciences, LLC | 2012-08-22 |
| ELITECH CLINICAL SYSTEMS CK NAC SL (K122083) | Elitechgroup | 2012-08-22 |
| SWANNSHIDI BONE MARROW ASPIRATION NEEDLE (K121181) | Alliance Partners, LLC | 2012-08-22 |
| INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR (K121536) | Sorin Group Italia S.R.L. | 2012-08-22 |
| OSTEOMED CRANIAL DISTRACTION SYSTEM (K121304) | Osteomed | 2012-08-22 |
| HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY (K121550) | Ethicon Endo-Surgery, LLC | 2012-08-22 |
| MTA-FILLAPEX (K113568) | Paxmed International | 2012-08-21 |
| SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K111627) | Idev Technologies, Inc. | 2012-08-21 |
| CD HORIZON SPINAL SYSTEM (K121764) | Medtronic Sofamor Danek, Inc. | 2012-08-21 |
| CLEVER CHOICE (K120921) | Simple Diagnostics, Inc. | 2012-08-21 |
| HY-CHLO(TM)WOUND SCRUB (K113312) | Patrin Pharma | 2012-08-21 |
| TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM (K112916) | Tyson Bioresearch, Inc. | 2012-08-21 |
| BONE PLUS BCP EAGLE EYE (K122240) | Megagen Implant Co., Ltd. | 2012-08-21 |
| GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING (K121485) | Hemcon Medical Technologies Europe, Ltd. | 2012-08-21 |
| VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM (K121063) | Ge Medical System Israel , Ltd. | 2012-08-21 |
| VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM (K111914) | Olympus America Inc. / Scientific Equipment Group | 2012-08-21 |
| ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES (K113062) | Endoservice Optical Instruments GmbH | 2012-08-21 |
| ULTRASONIC NEBULIZER (K121154) | Foshan Gaunying Electronics Co., Ltd. | 2012-08-20 |
| VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE) (K122179) | Compression Therapy Concepts | 2012-08-20 |
| OPTO HYALUS GREEN LASER (K111460) | Opto Eletronica S/A | 2012-08-20 |
| AVS AS PEEK SPACER (K120486) | Stryker Spine | 2012-08-20 |
| DYNATRON THERMOSTIM PROBE-DONE (K120835) | Dynatronics Corporation | 2012-08-20 |
| THE PAIN PILOT (A.K.A PAIN PILOT) (K120500) | Hollywog, LLC | 2012-08-20 |
| GRIDLOCK PLATING SYSTEM (K121452) | Trilliant Surgical, Ltd. | 2012-08-20 |
| SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D (K121148) | Medical Design, LLC | 2012-08-20 |
| WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM (K121720) | Welkins, LLC | 2012-08-20 |
| OCTAVE SPEEDER SPINE (K121911) | Toshiba Medical Systems Corporation, Japan | 2012-08-17 |
| MEDLINE HIGH PRESSURE INJECTION TUBING (K120008) | Medline Industries, Inc. | 2012-08-17 |
| VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM (K121062) | Ge Medical System Israel , Ltd. | 2012-08-17 |
| VENOFER PUMP (K121497) | Renal Solutions, Inc. | 2012-08-17 |
| ATRIUM FLIXENE IFG VASCULAR GRAFT (K122138) | Atrium Medical Corp. | 2012-08-17 |
| NEBULAE I (K120151) | Northgate Technologies, Inc. | 2012-08-17 |
| MICROAIRE SURGICAL INSTRUMENTS LLC (K113128) | Microaire Surgical Instruments, LLC | 2012-08-17 |
| TAPERLOC COMPLETE SIZE 4MM AND XR 123 (K120030) | Biomet Manufacturing Corp | 2012-08-17 |
| PRELUDE 7F SHORT SHEATH INTRODUCER (K122190) | Merit Medical Systems, Inc. | 2012-08-17 |
| A-V FOOT PUMP (K121718) | Dalian Labtek Science & Development Co., Ltd. | 2012-08-17 |
| CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION (K112373) | Innova Vision, Inc. | 2012-08-17 |
| POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE (K120890) | Shen Wei (Usa), Inc. | 2012-08-17 |
| YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION (K121025) | Ya Horng Electronic Co., Ltd. | 2012-08-17 |
| LANX SPINAL FIXATION SYSTEM (K122145) | Lanx, Inc. | 2012-08-17 |
| OCTAVE SPEEDER HEAD (K121910) | Toshiba Medical Systems Corporation, Japan | 2012-08-17 |
| STGC (K121176) | Cardinal Spine, LLC | 2012-08-17 |
| TRUETOME (K122203) | Boston Scientific Corp | 2012-08-17 |
| LUNG VOLUME ANALYSIS (K113715) | Toshibamedical Systems Corporation | 2012-08-17 |
| HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (K113809) | Hitachi Chemical Diagnostics, Inc. | 2012-08-17 |
| DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC (K122182) | Rayence Co., Ltd. | 2012-08-16 |
| SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) (K121548) | Spine View, Inc. | 2012-08-16 |
| OEC 9900 ELITE (K122234) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-08-16 |
| RESPROCESSED SERFAS ENERGY PROBE (K121855) | Stryker Sustainability Solutions | 2012-08-16 |
| STRATIFY JCV DXSELECT (K120986) | Focus Diagnostics, Inc. | 2012-08-16 |
| VITEK 2 AST-ST CEFOTAXIME (K121863) | bioMerieux, Inc. | 2012-08-16 |
| CHORD-X EPTFE SUTURE (K121173) | On-Xlifetechnologies | 2012-08-16 |
| APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM (K121422) | Toshiba Medical Systems Coporation, Japan | 2012-08-16 |
| DX-D IMAGING PACKAGE (K121095) | Agfa Healthcare N.V. | 2012-08-16 |
| BIOJET (K122329) | Jet Soft Srl | 2012-08-16 |
| WITOUCH PRO (K120398) | Hollywog, LLC | 2012-08-16 |
| ALTOMEC ARTHROSCOPE (K112548) | Altomec Endoscopy, Inc. | 2012-08-15 |
| 4CIS VANE SPINE SYSTEM (K121615) | Solco Biomedical Co., Ltd. | 2012-08-15 |
| VISI MOBILE MONITORING SYSTEM (K122036) | Sotera Wireless, Inc. | 2012-08-15 |
| MOVATION KNEE SYSTEM (K121727) | Encore Medical L.P. | 2012-08-15 |
| ARMADA 14XXT PTA CATHETER (K121352) | Abbott Vascular | 2012-08-15 |
| EXINI (K122205) | Exini Diagnostics AB | 2012-08-15 |
| GID 700 (K120902) | The Gid Group, Inc. | 2012-08-15 |
| CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G (K122070) | Trireme Medical, Inc. | 2012-08-15 |
| BIOHARNESS (K113045) | Zephyr Technology Corporation | 2012-08-14 |
| CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS (K120158) | Thomas Medical Products, Inc. | 2012-08-14 |
| DYNAFLEX (K121396) | Dyna Flex | 2012-08-14 |
| VIALOK SINGLE VIAL ACCESS DEVICE VENTED (K122265) | Yukon Medical, LLC | 2012-08-14 |
| CONNECTED CARE CLINICAL APPLICATION (K120320) | Watermark Medical, Inc. | 2012-08-14 |
| DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (K122126) | Randox Laboratories Limited | 2012-08-14 |
| EXACTRAC X-RAY X-RAY (K120789) | Brainlab AG | 2012-08-14 |
| C100 WRINKLE REDUCTION DEVICE (K112362) | Silver Bay, LLC | 2012-08-14 |
| VARIOECO (K121334) | Thommen Medical AG | 2012-08-14 |
| AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE (K121776) | Codman & Shurtleff, Inc. | 2012-08-14 |
| TABLET COMMANDER (K122285) | Cardiocom, LLC | 2012-08-14 |
| SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER (K121819) | Covalontechnologies, Inc. | 2012-08-13 |
| CERASORB PLUS (K120152) | Riemser Arzneimittel AG | 2012-08-13 |
| NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) (K121667) | Boston Scientific Corp | 2012-08-13 |
| JOURNEY II CR KNEE SYSTEM (K121443) | Smith & Nephew, Inc. | 2012-08-13 |
| ERISMA-LP (K120469) | Clariance | 2012-08-13 |
| FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 (K120446) | Fujinon, Inc. | 2012-08-13 |
| MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 (K122246) | Celleration, Inc. | 2012-08-13 |
| MEDICAL AIR COMPRESSOR (K113338) | Oricare, Inc. | 2012-08-10 |
| LUBE JELLY SURINGE (K121390) | Nurse Assist, Inc. | 2012-08-10 |
| LIFECELL TISSUE EXPANDER (K112534) | Lifecell Corp. | 2012-08-10 |
| MULTIX FUSION (K121513) | Siemens Medical Solution | 2012-08-10 |
| SPIRALE DRUG DELIVERY SYSTEM (K111246) | Armstrong Medical , Ltd. | 2012-08-10 |
| IMRIS ONCOLOGY PACKAGE (K121997) | Imris, Inc. | 2012-08-10 |
| SCEPTER C OCCLUSION BALLOON CATHETER (K121785) | MicroVention, Inc. | 2012-08-10 |
| ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT (K113210) | Isoaid, LLC | 2012-08-10 |
| WIRELESS IMAGE TRANSMITTER UNIT (K120278) | Olympus Medical Systems Corp. | 2012-08-10 |
| BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT (K121197) | Preventice, Inc. | 2012-08-10 |
| COMFORT EZ (K121632) | Simple Diagnostics, Inc. | 2012-08-10 |
| AIMAGO EASYLDI MICROCIRCULATION CAMERA (K121429) | Aimago SA | 2012-08-10 |