| VANTAGE TITAN 3T (K120487) | Toshibamedical Systems Corporation | 2012-05-23 |
| PUSH-ON NEEDLE 30GX8MM (K120191) | Scandinavian Health Limited | 2012-05-23 |
| SOMATOM DEFINITION EDGE (K120579) | Siemens Medical Systems, Inc. | 2012-05-23 |
| LEXUS CERVICAL FIXATION SYSTEM (K120879) | L&K BIOMED Co., Ltd. | 2012-05-23 |
| PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS (K120934) | Cardinal Health, Inc. | 2012-05-23 |
| MYLABSOGNO (K121384) | Esaote, S.p.A. | 2012-05-23 |
| TEMPUS CERVICAL PLATE SYSTEM (K120515) | Neurostructures, LLC | 2012-05-23 |
| ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP (K111262) | Olsen Medical | 2012-05-23 |
| SOMATOM PERSPECTIVE (K113287) | Siemens Medical Solutions USA, Inc. | 2012-05-23 |
| PALOMAR VECTUS LASER (K120622) | Palomar Medical Technologies, Inc. | 2012-05-23 |
| HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX (K111575) | Orthocon, Inc. | 2012-05-23 |
| CONTOUR TECHNOLOGY MUSCLE STIMULATOR (K111476) | Contour Technology | 2012-05-23 |
| LUCENT OR LUCENT MAGNUM (K110632) | Spinal Elements, Inc. | 2012-05-23 |
| DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX (K120284) | Coloplast A/S | 2012-05-23 |
| MANUKA IG (K120976) | Links Medical Products, Inc. | 2012-05-23 |
| AERODR X70 (K121109) | Konica Minolta Medical & Graphic, Inc. | 2012-05-23 |
| MANUKA FILL (K121227) | Links Medical Products, Inc. | 2012-05-23 |
| REACH SURGICAL STAPLERS (K120179) | Reach Surgical, Inc. | 2012-05-23 |
| HIGH FIVE (K113440) | Central Medicare Sdn Bhd | 2012-05-23 |
| VILET VILET QUICK (K120556) | Riverpoint Medical | 2012-05-23 |
| UNIVERSAL DIGITAL INTERFACE (UDI) 1717 (K112527) | Meridian Medical Systems, LLC | 2012-05-22 |
| VIEWRAY SYSTEM (K111862) | Viewray, Incorporated | 2012-05-22 |
| BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES (K120533) | Bridgepoint Medical | 2012-05-22 |
| TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM (K120042) | Taidoc Technology Corporation | 2012-05-22 |
| CELL SAVER ELITE (K120586) | Haemonetics Corp. | 2012-05-22 |
| NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) (K112881) | Nexstim OY | 2012-05-22 |
| TAPER SET HIP SYSTEM RDP STEM (K121263) | Consensus Orthopedics, Inc. | 2012-05-22 |
| SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE (K113103) | Rex Medical | 2012-05-22 |
| TEMPSPAN CLEAR MATRIX (K120013) | Pentron Clinical | 2012-05-22 |
| AMPHIRION PLUS PTA CATHETER (K121265) | Medtronic, Inc. | 2012-05-22 |
| NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE (K120443) | Baxter Healthcare Corporation - Renal Division | 2012-05-22 |
| DYNA LOCKING ANKLE NAIL (K120419) | U&I Corp. | 2012-05-21 |
| ORTHODONTIC FLOWABLE BRACKET ADHESIVE (K120619) | Novocol, Inc. | 2012-05-21 |
| FALLER TROCAR (K120130) | Medigroup, Inc. | 2012-05-21 |
| VISIONSEARCH 1 (K120104) | Visionsearch Pty, Ltd. | 2012-05-21 |
| MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH (K120404) | Merz Dental GmbH | 2012-05-21 |
| IMPULSE AND EXPO ANGIOGRAPHIC CATHETER (K120495) | Boston Scientific Corp | 2012-05-21 |
| XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) (K120911) | Cepheid | 2012-05-18 |
| METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS (K113271) | Biomet Manufacturing, Inc. | 2012-05-18 |
| ORION II CT CVC (K113622) | Health Line International Corporation (Hlic) | 2012-05-18 |
| MIROCAM CAPSULE ENDOSCOPE SYSTEM (K111450) | Intromedic Co., Ltd. | 2012-05-18 |
| CONCENTRIC BALLOON GOOGLE (K112698) | United States Endoscopy Group, Inc. | 2012-05-18 |
| R&D INNOVATION PEDICLE SCREW SYSTEM (K120091) | R&D Innovation, LLC | 2012-05-18 |
| EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K121207) | Eps Bio Technology Corp. | 2012-05-18 |
| LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) (K121143) | Bio-Rad Laboratories | 2012-05-18 |
| SYNTHES MATRIX SYSTEM (K120928) | Synthes Spine | 2012-05-18 |
| DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM (K113576) | Etview , Ltd. | 2012-05-18 |
| PERMACOL SURGICAL IMPLANT (K120605) | Covidien, LLC | 2012-05-18 |
| RANGE SPINAL SYSTEM (MESA AND DENALI) (K120099) | K2m, Inc. | 2012-05-18 |
| SRS ENDOSCOPIC STAPLING SYSTEM (K120299) | Medigus , Ltd. | 2012-05-18 |
| MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN (K113565) | Edwards Lifesciences, LLC | 2012-05-18 |
| LEFORTE SYSTEM BONE PLATE & SCREW (K112457) | Arkin Consulting Group | 2012-05-18 |
| BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE (K121237) | Cliniqa Corporation | 2012-05-18 |
| GENESIS II PS NON-MODULAR FEMORAL COMPONENT (K120698) | Smith & Nephew, Inc. | 2012-05-18 |
| ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT (K113253) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-05-17 |
| LONG LIFE PADTM (K120516) | Omron Healthcare, Inc. | 2012-05-17 |
| TISSUE OF ORIGIN TEST KIT FFPE (K120489) | Pathwork Diagnostics, Inc. | 2012-05-17 |
| MRI SYTEMS (K113281) | Shenzhen Anke High-Tech Co., Ltd. | 2012-05-17 |
| ARCHITECT B12 (K121314) | Abbott Laboratories | 2012-05-17 |
| HEARTCHECK ECG PEN WITH GEMS HOME (K121009) | Cardiocomm Solutions, Inc. | 2012-05-17 |
| HAYMAX (K120894) | Haymax Limited | 2012-05-17 |
| PRESTO BREAST BIOPSY DEVICE (K120440) | Sontina Medical, LLC | 2012-05-17 |
| LIQUID BANDAGE (K120059) | Chesson Laboratory Associates, Inc. | 2012-05-17 |
| EVOLUTION COLONIC STENT SYSTEM (K113510) | Cook Ireland, Ltd. | 2012-05-17 |
| XPRESS MULTI-SINUS DILATION TOOL (K121174) | Entellus Medical, Inc. | 2012-05-17 |
| RESTORELLE POLYPROPYLENE Y MESH (K112322) | Coloplast A/S | 2012-05-17 |
| MINI CANNULATED HEADED AND HEADLESS SCREW SET (K120493) | Instratek, Inc. | 2012-05-17 |
| ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM (K121138) | Siemens Medical Solution | 2012-05-17 |
| CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS (K121339) | Chemtron Biotech, Inc. | 2012-05-17 |
| HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 (K120729) | Ethicon Endo-Surgery, LLC | 2012-05-17 |
| ARTHREX MIXING AND DELIVERY SYSTEM (K121124) | Arthrex, Inc. | 2012-05-16 |
| CLEARPATH LOWER GI (K113050) | Easyglide , Ltd. | 2012-05-16 |
| PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K112127) | Smith & Nephew, Inc. | 2012-05-16 |
| FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER (K103658) | Teleflex, Inc. | 2012-05-16 |
| APEX MEDICAL ICH CPAP SERIES (9S-007XXX) (K120035) | Apex Medical Corp. | 2012-05-16 |
| GENOSYL MV-1000 (K120216) | Geno, LLC | 2012-05-16 |
| VANGUARD SSK 360 REVISION KNEE SYSTEM (K121149) | Biomet Manufacturing Corp | 2012-05-16 |
| TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT (K120287) | Church & Dwight Co., Inc. | 2012-05-16 |
| PATIENT MONITOR (K120173) | Edan Instruments, Inc. | 2012-05-16 |
| MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (K112921) | Medicalgorithmics S.A. | 2012-05-16 |
| VARAYA AR , VARAYA SPORT (K112494) | Varaya Photoceuticals, LLC | 2012-05-16 |
| CLEARPATH UPPER GI (K113166) | Easyglide , Ltd. | 2012-05-16 |
| RADIAL JAW 4 PULMONARY BIOPSY FORCEPS (K121186) | Boston Scientific Corp | 2012-05-16 |
| QLAB WITH FHN AND VPQ PLUG-IN (K121223) | Philips Ultrasound, Inc. | 2012-05-15 |
| ADVIA CHEMISTRY GLUH_3 REAGENTS (K120681) | Siemens Healthcare Diagnostics, Inc. | 2012-05-15 |
| FILMARRAY RP PANEL (K120267) | Idaho Technology, Inc. | 2012-05-15 |
| SWITCH-IT CATHETER (K120707) | Vascular Solutions, Inc. | 2012-05-15 |
| TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM (K121141) | Tensys Medical Systems, Inc. | 2012-05-15 |
| S 100 PEDICLE SCREW SYSTEM (K111940) | Renovis Surgical Technologies, LLC | 2012-05-15 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR (K113194) | Suqian Ruijang Medical Supplies Co., Ltd. | 2012-05-14 |
| MLS, ZERONA-AD (K120257) | Erchonia Medical, Inc. | 2012-05-14 |
| SYNTHES USS CONNECTOR (K120571) | Synthes Spine | 2012-05-14 |
| COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B (K111188) | Roche Diagnostics | 2012-05-14 |
| SR PHONARES II (K120736) | Ivoclar Vivadent, AG | 2012-05-14 |
| TINA-QUANT ALBUMIN GEN.2 (K113072) | Roche Diagnostics Operations | 2012-05-14 |
| ROCAMED ROCAUS PLATINUM (K120160) | Promepla Sam | 2012-05-14 |
| EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL (K120497) | Medica Corp. | 2012-05-14 |
| LATEX EXAMINATION GLOVES (POWDER FREE) (K120692) | Top Calibre Sdn Bhd | 2012-05-14 |
| GEL-BLOCK EMBOLIZATION PLEDGETS (K113266) | Vascular Solutions, Inc. | 2012-05-14 |
| COMED K-SERIES MANUAL WHEELCHAIR (K120077) | Danyang Comed Healthcare Co., Ltd. | 2012-05-14 |