| HOME PREGNANCY TEST (K112315) | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 2012-04-23 |
| EARLOGIC OAE TESTER (K112992) | Earlogic Corporation | 2012-04-20 |
| PALTOP DENTAL IMPLANT SYSTEM (K112795) | Paltop Advanced Dental Solutions, Ltd. | 2012-04-20 |
| SAFETY SCREW CONNECTOR (K113719) | Abbott Laboratories | 2012-04-20 |
| MCKESSON ANESTHESIA CARE (K113633) | Mckesson Technologies, Inc. | 2012-04-20 |
| BLUWHITE DIAMOND DENTAL BURS MODIFIED (K120037) | Beavers Dental, Div. Sybron Canada, Ltd. | 2012-04-20 |
| NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, (K120853) | Bioness, Inc. | 2012-04-20 |
| 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W (K113240) | Eizo Nanao Corporation | 2012-04-20 |
| RAPID PROGRAMMER (K113611) | St Jude Medical | 2012-04-20 |
| EASYCARE TX SYSTEM (CONNEXUNS) (K113780) | Resmed, Ltd. | 2012-04-20 |
| EXCELSIOR XT-27 MICROCATHETER (K113778) | Stryker Neurovascular | 2012-04-20 |
| CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES (K120208) | Mauna Kea Technologies | 2012-04-20 |
| NEO CR KNEE SYSTEM (K120313) | Pipeline Orthopedics | 2012-04-20 |
| FENESTRATED NERVE BLOCK NEEDLE (K113662) | Imd, Inc. | 2012-04-20 |
| MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER (K120868) | Datascope Corp., Cardiac Assist Division | 2012-04-20 |
| ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS (K120872) | Unomedical A/S Infusion Devices | 2012-04-20 |
| SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML (K120051) | Nephron Pharmaceuticals Corp. | 2012-04-20 |
| GORE DRYSEAL SHEATH (K120428) | W. L. Gore & Associates, Inc. | 2012-04-20 |
| PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC (K120942) | Parcus Medical, LLC | 2012-04-20 |
| OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 (K111425) | Olympus Medical Systems Corp. | 2012-04-20 |
| SALINE WOUND WASH (K112666) | Nanoplas, Inc. | 2012-04-20 |
| PRE-LOADED GOLD VISICOIL CK MARKER (K120859) | Radiomed Corporation | 2012-04-19 |
| RIVAL PTA DILATATION CATHETER (K120722) | Bard Peripheral Vascular, Inc. | 2012-04-19 |
| VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM (K120063) | L&K BIOMED Co., Ltd. | 2012-04-19 |
| ATLAS PTA BALLOON DILATATION CATHETER (K120971) | Bard Peripheral Vascular, Inc. | 2012-04-19 |
| PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES (K111464) | Dipped Products (Thailand), Ltd. | 2012-04-19 |
| NOVAC 11 (K112286) | New Radiant Technology S.P.A. | 2012-04-19 |
| PHILIPS MICRODOSE (K120255) | Philips Digital Mammography Sweden AB | 2012-04-19 |
| EZONO 3000 (K120234) | Life-Tech, Inc. | 2012-04-19 |
| M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM (K121010) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-04-19 |
| MODULAR PROXIMALLY FLUTED HIP STEM (K113789) | Smith & Nephew, Inc. | 2012-04-19 |
| OTIS-C PLUS (K120818) | Science For Biomaterials | 2012-04-19 |
| ORBIT (K120880) | National Biomedical, LLC Dba Qrs Diagnostic | 2012-04-19 |
| PULSE OXIMETER (K112843) | Nonin Medical, Inc. | 2012-04-19 |
| PRIMUS HEARING INSTRUMENT TEST UNIT (K113831) | Auditdata A/S | 2012-04-19 |
| 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 (K120407) | Eizo Nanao Corporation | 2012-04-19 |
| GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K120201) | Ge Vingmed Ultrasound AS | 2012-04-19 |
| RESOLUTIONMD WEB (K120076) | Calgary Scientific, Inc. | 2012-04-19 |
| DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM (K120699) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-04-19 |
| VIRTUOSO SYSTEM FOR IHC P53 (DO-7) (K111872) | Ventana Medical Systems, Inc. | 2012-04-19 |
| NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA (K113494) | Nobles Medical Technologies Ii, Inc. | 2012-04-19 |
| ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K120316) | Conformis, Inc. | 2012-04-19 |
| OLEA SPHERE (K120196) | Olea Medical | 2012-04-19 |
| WHOLEY GUIDE WIRE SYSTEM (K120863) | Covidien, LLC | 2012-04-19 |
| INSTAPACS/INSTARISPACS (K120718) | Meddiff Technologies Pvt. , Ltd. | 2012-04-19 |
| NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES (K120182) | Neomed, Inc. | 2012-04-19 |
| SONICISION STERILIZATION TRAY (K112536) | Covidien | 2012-04-19 |
| OPTIMA NM/CT 640 (K121019) | GE Healthcare | 2012-04-19 |
| WUNDER TEST (K102428) | Hien Helen Nguyen | 2012-04-18 |
| AB DENTAL DEVICES IMPLANTS AND ACCESSORIES (K112440) | A.B. Dental Devices , Ltd. | 2012-04-18 |
| MANTARAY GUIDEWIRES (K120881) | Bridgepoint Medical | 2012-04-18 |
| ZHENJIANG ASURE MECHANICAL WHEELCHAIR (K112816) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2012-04-18 |
| TWIN PEAKS LUMBAR CAGE (K112696) | Qualgenix, LLC | 2012-04-18 |
| NEXUS TKO-6, LUER-ACTIVATED DEVICE (K113398) | Nexus Medical, LLC | 2012-04-18 |
| VERSAFITCUP CC TRIO-ADDITIONAL LINERS (K120531) | Medacta International | 2012-04-18 |
| JAZZY ELITE 6 (K113488) | Pride Mobility Product Corporration | 2012-04-18 |
| ON CALL CHOSEN LANCING DEVICE (K113332) | ACON Laboratories, Inc. | 2012-04-18 |
| SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS (K113586) | Synergeyes, Inc. | 2012-04-18 |
| INZONE DETACHMENT SYSTEM (K120816) | Stryker | 2012-04-17 |
| LIAC (K110840) | Sordina S.P.A. | 2012-04-17 |
| VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES (K112305) | Thunder Tiger Corp. | 2012-04-17 |
| TARGET DETACHABLE COIL (K120850) | Stryker Neurovascular | 2012-04-17 |
| AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES (K120028) | Pegavision Corporation | 2012-04-17 |
| 3MENSIO WORKSTATION (K120367) | Pie Medical Imaging BV | 2012-04-17 |
| INTRAOSSEOUS FIXATION SYSTEM (K120165) | Orthohelix Surgical Designs, Inc. | 2012-04-17 |
| RADIOGRAPHIC X-RAY SYSTEM (K120034) | Orich Medical Equipment (Tianjin Co., Ltd. | 2012-04-17 |
| NEXTGEN ALTIUS OCT SYSTEM (K113593) | Biomet Spine (Aka Ebi, LLC) | 2012-04-17 |
| COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) (K121001) | Novitas Medical, LLC | 2012-04-17 |
| LOFRIC SINGLE USE URINARY CATHETER (K113424) | Astra Tech AB | 2012-04-17 |
| DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 (K120591) | Diamond Diagnostics, Inc. | 2012-04-17 |
| RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME (K112928) | Riverstone Resources Sdn Bhd | 2012-04-17 |
| HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL (K111999) | Healgen Scientific,, LLC | 2012-04-17 |
| IND URINARY TRACT INFECTION (UTI) TEST STRIPS (K103037) | Ind Diagnostic, Inc. | 2012-04-17 |
| NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) (K120830) | Carticept Medical, Inc. | 2012-04-16 |
| SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER (K120403) | Transenterix, Inc. | 2012-04-16 |
| OP SPINE SYSTEM (K120291) | OrthoPediatrics Corp. | 2012-04-16 |
| CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM (K120117) | Codman & Shurtleff, Inc. | 2012-04-16 |
| TRANSCORP SPINAL ACCESS SYSTEM (K113352) | Transcorp, Inc. | 2012-04-16 |
| SUPERCATH Z3V (K112290) | Togo Medikit Co., Ltd. | 2012-04-16 |
| ESCALATE LAMINOPLASTY SYSTEM (K113802) | Stryker Spine | 2012-04-16 |
| DUAL HEATED INFANT VREATHING CIROUITS (K103767) | Fisher & Paykel Healthcare, Ltd. | 2012-04-16 |
| PLYMOUTH THORACOLUMBAR PLATE SYSTEM (K120092) | Globus Medical, Inc. | 2012-04-13 |
| CT-GUIDE NEEDLE GUIDANCE SYSTEM (K120300) | Activiews, Ltd. | 2012-04-13 |
| CLEARVISION DR 7000F (K102327) | Jpi Healthcare Co, Ltd. | 2012-04-13 |
| MICRO I (K113096) | Carefusion Germany 234 GmbH | 2012-04-13 |
| FLEXITOUCH SYSTEM (K120972) | Tactile Systems Technology, Inc. | 2012-04-13 |
| NUVASIVE NVJJB SYSTEM (K112717) | Nuvasive, Inc. | 2012-04-13 |
| SYNGO CT DYNAMIC ANGIO (K120331) | Siemens AG Medical Solutions | 2012-04-13 |
| INTRABEAM NEEDLE APPLICATOR (K110590) | Carl Zeiss Surgical GmbH | 2012-04-13 |
| PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE (K120805) | Angioslide, Ltd. | 2012-04-13 |
| SMARTEPIL,DEPILASE YAG LASE PLUS (K112141) | Castle Laser Systems, Limited | 2012-04-13 |
| 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 (K120135) | Tomtec Imaging Systems GmbH | 2012-04-13 |
| ASCEND SHOULDER SYSTEM (K120794) | Tornier, Inc. | 2012-04-13 |
| ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM (K120703) | Zonare Medical Systems, Inc. | 2012-04-13 |
| SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION (K120315) | Siemens Medical Solutions USA, Inc. | 2012-04-13 |
| DRX-REVOLUTION MOBILE X-RAY SYSTEM (K120062) | Carestream Health, Inc. | 2012-04-13 |
| MECHANICAL WHEELCHAIR (K120032) | Aikin Healthcare Co., Ltd. | 2012-04-13 |
| ALPHAPOINT IMAGING SOFTWARE (K120161) | Radlogics, Inc. | 2012-04-13 |
| CAPLOX II PEDICLE SCREW SYSTEM (K120292) | Captiva Spine, Inc. | 2012-04-13 |
| BILI-THERAPY PAD TYPE (K111547) | Atom Medical Corporation | 2012-04-12 |