| MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY (K113215) | Nonin Medical, Inc. | 2012-05-14 |
| COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM (K120166) | Won Industrial Co. | 2012-05-14 |
| DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR (K120798) | Canopus Medical Supply Co., Ltd. | 2012-05-14 |
| SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS (K121127) | Cynosure, Inc. | 2012-05-13 |
| ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM (K120183) | Broadmaster Biotech Corperation | 2012-05-11 |
| HEALIX ADVANCE PEEK ANCHOR (K120449) | Depuy Mitek | 2012-05-11 |
| KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS (K113333) | Kimberly-Clark Corporation | 2012-05-11 |
| TATTOOSTAR EFFECT Y (K112669) | Asclepion Laser Technologies GmbH | 2012-05-11 |
| SUNMED GUIDE WIRE (K120119) | Sunny Medical Device (Shenzhen) Co., Ltd. | 2012-05-11 |
| TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT (K120249) | Church & Dwight Virginia Co., Inc. | 2012-05-11 |
| CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER (K120296) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-05-11 |
| DOBBHOFF DUAL PORT FEEDING TUBE (K112511) | Covidien Lp, Formerly Registered AS Kendall | 2012-05-11 |
| ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (K120057) | Bioptigen, Inc. | 2012-05-11 |
| INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR (K120185) | Sorin Group Italia S.R.L. | 2012-05-11 |
| LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM (K120821) | Misder, LLC | 2012-05-11 |
| ILWAIT TIMER OCULOPRESSOR (K112952) | Oryx Medical Pty, Ltd. | 2012-05-10 |
| EOS SMALL BONE FIXATION SYSTEM (K112794) | TriMed, Inc. | 2012-05-10 |
| GC BLUE SILICONE (K120521) | GC America, Inc. | 2012-05-10 |
| ARRW EVOLUTION (K112896) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-05-10 |
| AQUAMANTYS3 9.5 XL BIPOLAR SEALER (K120537) | Medtronic, Inc. | 2012-05-10 |
| MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS (K112158) | Lima Corporate S.P.A. | 2012-05-10 |
| EZSENSOR P DIGITAL INTRAORAL SENSOR (K121132) | Humanray Co,Ltd | 2012-05-10 |
| SENTRYSUITE PRODUCT LINE (K113813) | Carefusion Germany 234 GmbH | 2012-05-10 |
| LUCINA-MELODI (K112856) | Genadyne Biotechnologies, Inc. | 2012-05-10 |
| HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) (K120369) | Hitachi Chemical Diagnostics, Inc. | 2012-05-10 |
| VERTESSA (K120327) | Caldera Medical, Inc. | 2012-05-10 |
| ELECSYS LH CALCHECK 5 (K121279) | Roche Diagnostics | 2012-05-10 |
| POCKETCPR (K112660) | Zoll Medical Corp | 2012-05-10 |
| COMPLETE D 25-OH VITAMIN D CONTROL (K113177) | Quantimetrix Corp. | 2012-05-10 |
| SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM (K120353) | Bm Korea Co., Ltd. | 2012-05-09 |
| LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L (K121084) | Siemens Healthcare Diagnostics, Inc. | 2012-05-09 |
| DSS STABILIZATION SYSTEM-RIGID (K120491) | Paradigm Spine, LLC | 2012-05-09 |
| G+ SYSTEM (K113853) | Glytec, LLC | 2012-05-08 |
| RANDOX COCAINE METABOLITE (K113751) | Randox Laboratories, Ltd. | 2012-05-08 |
| OPHIRA MINI SLING SYSTEM (K110420) | Promedon S.A | 2012-05-08 |
| CALCIUM GEN. 2 (K113521) | Roche Diagnostics | 2012-05-08 |
| LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS (K120761) | Lin-Zhi International, Inc. | 2012-05-08 |
| CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE (K120298) | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-05-08 |
| LATEX EXAMINATION GLOVES (POWDERED) (K120693) | Top Calibre Sdn Bhd | 2012-05-08 |
| AMSCO CHIMERON MEDIUM STEAM STERLILZER (K112403) | STERIS Corporation | 2012-05-08 |
| COBES SURGICAL DRAPE (K112378) | Cobes Industries Co., Ltd. | 2012-05-08 |
| TERUMO PALL AL20X ARTERIAL FILTER (K121209) | Terumo Cardiovascular Systems Corporation | 2012-05-08 |
| GLOW BY ENDYMED (K120513) | Endymed Medical, Ltd. | 2012-05-08 |
| PLATEAU SPACER SYSTEM (K121116) | Life Spine | 2012-05-08 |
| SYNAPSE 3D BRAIN PERFUSION (K120637) | Fujifilm Medical System U.S.A., Inc. | 2012-05-08 |
| PERFORMER HT/ HANG&GO HT BASIC (K120026) | Rand S.R.L. | 2012-05-08 |
| RELIANCE CERVICAL IBF SYSTEM (K120396) | Reliance Medical Systems, LLC | 2012-05-08 |
| MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR (K113577) | Merits Health Products Co., Ltd. | 2012-05-08 |
| ELEMENT BLOOD GLUCOSE MONITORING SYSTEM (K113670) | Infopia Co, Ltd. | 2012-05-08 |
| INFU BOX TYPE 0412A (K120860) | Medical Rescue Equipment Holding AS | 2012-05-08 |
| SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) (K120717) | Synthes USA | 2012-05-08 |
| NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX (K113451) | Nidek Technologies Srl | 2012-05-08 |
| LIFESTYLES ZERO LUBRICATED LATEX CONDOM (K120394) | Ansell Heathcare Products, LLC | 2012-05-08 |
| VENOUS DRAINAGE CANNULA WITH DURAFLO COATING (K120072) | Edwards Lifesciences, LLC | 2012-05-08 |
| C2 MEDICAL GLOVES (K113639) | Amercare, Inc. | 2012-05-08 |
| SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA (K120149) | Sakura Seiki Co., Ltd. | 2012-05-08 |
| WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL (K121166) | Guangzhou Wondfo Biotech Co., Ltd. | 2012-05-08 |
| PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY (K102841) | Pantex, Div. Bio-Analysis, Inc. | 2012-05-08 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K112266) | Shandong Zhiyuan Medical Products Co., Ltd. | 2012-05-08 |
| VEIN-GOGH INSTRUMENT (K112334) | Refine USA, LLC | 2012-05-08 |
| SOMATOM DEFINITION FLASH (K121072) | Siemens Medical Systems, Inc. | 2012-05-08 |
| IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) (K113732) | Brainlab AG | 2012-05-07 |
| APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM (K120106) | Apixia, Inc. | 2012-05-07 |
| GEN_2 MECHANICAL WHEELCHAIR (K113713) | Free Wheelchair Mission | 2012-05-07 |
| AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (K112790) | Axis-Shield Diagnostics, Ltd. | 2012-05-07 |
| PIONEER LATERAL PLATE SYSTEM (K120724) | Pioneer Surgical Technology, Inc. | 2012-05-07 |
| CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) (K120550) | Biosense Webster, Inc. | 2012-05-07 |
| UNITED U2 FEMORAL COMPONENT, PS, #7 (K120507) | United Orthopedic Corporation | 2012-05-04 |
| QUANTUM DENTAL IMPLANT SYSTEM (K112279) | Quantum Bioengineering, Ltd. | 2012-05-04 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (K121015) | Abbott Vascular | 2012-05-04 |
| IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER (K112549) | Covalontechnologies, Inc. | 2012-05-04 |
| DUKAL LUBRICATING JELLY (K113689) | Dukal Corporation | 2012-05-04 |
| COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS (K121057) | William Cook Europe Aps | 2012-05-04 |
| UNIMED DISPOSABLE BLOOD PRESSURE CUFF (K120364) | Unimed Medical Supplies, Inc. | 2012-05-04 |
| KENSEY NASH BONE VOID FILLER XC (K120141) | Kensey Nash Cororation | 2012-05-04 |
| POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (K112797) | Cordis Corp. | 2012-05-04 |
| END TIDAL CO2 NASAL CANNULA (K120518) | Care Fusion | 2012-05-04 |
| VIVIX-S (K120020) | Vieworks Co., Ltd. | 2012-05-04 |
| STERILCONTAINER SYSTEM (K112671) | Aesculap, Ltd. | 2012-05-04 |
| ACCUSONIC ADVANTAGE (K120171) | Metron Medical Australia, Pty, Ltd. | 2012-05-04 |
| METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY (K120362) | Corin USA | 2012-05-04 |
| TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE (K112665) | J. Morita USA, Inc. | 2012-05-04 |
| KIMBERLY-CLARK CHILD'S FACEMASK (K113340) | Kimberly-Clark | 2012-05-04 |
| HLIC NEEDLE-LESS VALVE (K120548) | Health Line International Corporation | 2012-05-04 |
| LOSPA TIBIAL BASE PLATE (K121037) | Corentec Co., Ltd. | 2012-05-03 |
| ORTHOLOC 3DI HALLUX SYSTEM (K120359) | Wrightmedicaltechnologyinc | 2012-05-03 |
| CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA (K120351) | I-Sens, Inc. | 2012-05-03 |
| EMBRACE THERMOPLASTIC (K120335) | Bionix Development Corp. | 2012-05-03 |
| RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE (K120344) | Radiadyne, LLC (Specification Developer) | 2012-05-03 |
| ENDO CLIP III 5MM CLIP APPLIER (K121194) | Covidien | 2012-05-03 |
| 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM (K120704) | 3M Company | 2012-05-03 |
| GEM PREMIER 4000 (K112995) | Instrumentation Laboratory CO | 2012-05-03 |
| ATAL-8 (K113812) | Atlaim | 2012-05-03 |
| GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM (K113341) | Hitachi Medical Systems America, Inc. | 2012-05-03 |
| VIALOK NON-VENTED (K121182) | Yukon Medical, LLC | 2012-05-03 |
| LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES (K112083) | <Genx> Intl., Inc. | 2012-05-03 |
| ES FLOW (K120768) | Spident Co., Ltd. | 2012-05-03 |
| HALO90 ULTRA ABLATION CATHETER (K120431) | Barrx Medical, Inc. | 2012-05-03 |
| VIPER SYSTEM (K121020) | Depuy Spine, Inc. | 2012-05-03 |
| RAPIDPOINT 500 BLOOD GAS ANALYER (K113216) | Siemens Healthcare Diagnostics | 2012-05-03 |