| COFLEX-F (K112595) | Paradigm Spine, LLC | 2012-02-13 |
| AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL (K113406) | Dentsply International, Inc. | 2012-02-13 |
| BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, (K111405) | Hangzhou Bever Medical Devices Co., Ltd. | 2012-02-13 |
| L-SER KO LAMP (K112016) | Ya-Man, Ltd. | 2012-02-10 |
| REGIUS SIGMA2 (K120131) | Konica Minolta Medical & Graphic, Inc. | 2012-02-10 |
| KINGYIELD WRIST BLOOD PRESSURE MONITOR (K112042) | Shenzhen Kingyield Technology Co., Ltd. | 2012-02-10 |
| SENSE MSK S 8CH 1.5T (K120122) | Invivo Corporation | 2012-02-10 |
| AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A (K113612) | Panasonic Healthcare Co., Ltd. | 2012-02-10 |
| AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION (K103044) | Bestgen Biotech Corp. | 2012-02-10 |
| SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) (K113542) | Salter Labs, Arvin Facility | 2012-02-10 |
| SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) (K113362) | Spine View, Inc. | 2012-02-10 |
| NOTOUCH BREASTSCAN (K113259) | Ue Lifesciences, Inc. | 2012-02-10 |
| VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE (K113305) | bioMerieux, Inc. | 2012-02-10 |
| AMID STAPLER (K120268) | Safestich Medical, LLC | 2012-02-10 |
| EIGR SURGICAL ILLUMINATION SYSTEM (K113697) | Invuity, Inc. | 2012-02-10 |
| MESO WOUND MATRIX (K112888) | Kensey Nash Corporation | 2012-02-10 |
| CRE DITATATION BALLON (K112994) | Boston Scientific Corporation | 2012-02-10 |
| EXTRICARE (K110078) | Devon Medical Products, Inc. | 2012-02-10 |
| PILLAR PALATAL IMPLANT SYSTEM (K110623) | Medtronic Xomed, Inc. | 2012-02-10 |
| CD HORIZON VOYAGER SPINAL SYSTEM (K113529) | Medtronic Sofamor Danek | 2012-02-09 |
| HAMILTON-TC1 (K112006) | Hamilton Medical AG | 2012-02-09 |
| INTEGRA WOUND MATRIX (THIN) (K113104) | Integra LifeSciences Corporation | 2012-02-09 |
| PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 (K113183) | Shanghai 3f Electronics Co, Ltd. | 2012-02-09 |
| AFX INTRODUCER SYSTEM (K120212) | Endologix, Inc. | 2012-02-09 |
| STIMULATION/DISSECTION INSTRUMENTS (K112709) | Nu Vasive, Incorporated | 2012-02-09 |
| HPR PLUS EMOLLIENT FOAM (K113774) | Prugen IP Holdings, Inc. | 2012-02-09 |
| SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS (K112407) | Smiths Medical MD, Inc. | 2012-02-09 |
| FLEXI-Q DV AND DVR AUTO-INJECTORS (K111467) | Elcam Medical Acal | 2012-02-09 |
| HPR EMOLLIENT FOAM (K113772) | Prugen IP Holdings, Inc. | 2012-02-09 |
| DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE (K113250) | Dynatronics Corp. | 2012-02-09 |
| ORTHOSLENDERIZER (K111249) | Orthomatics, Inc. | 2012-02-08 |
| DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM (K113343) | Delbio Incorporation | 2012-02-08 |
| JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS (K103726) | Integra LifeSciences Corporation | 2012-02-08 |
| VERACIA SA (K113426) | Shofu Dental Corporation | 2012-02-08 |
| YOMURA SAFETY I.V. CATHETER (K112542) | Yomura Technologies, Inc. | 2012-02-08 |
| IM BAND (K113600) | Synexmed(Shenzhen)Company Limited | 2012-02-08 |
| EPIGRAY (K112723) | Dosisoft SA | 2012-02-08 |
| CLEARFLASH AC2100 COSMETIC SYSTEM (K111937) | Clearflash Technologies, Inc. | 2012-02-08 |
| WINGMAN EXTENDABLE TIP SUPPORT CATHETER (K120178) | Reflow Medical | 2012-02-08 |
| PUREIMAGE ULTRASOUND TRANSMISSION GEL (K120156) | Medline | 2012-02-08 |
| SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) (K120083) | Synthes USA | 2012-02-08 |
| DEPUY PULSE THORACOLUMBAR SCREW SYSTEM (K113396) | Medos International SARL | 2012-02-08 |
| MEDICAL IMAGE PROCESSING UNIT (K113360) | Humanray Co,Ltd | 2012-02-07 |
| PROPHY-MATE NEO (K112673) | Nakanishi, Inc. | 2012-02-07 |
| CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER (K112383) | Skeletal Kinetics, LLC | 2012-02-07 |
| ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS (K111678) | Ortho Solutions Limited | 2012-02-07 |
| TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT (K113021) | CSA Medical, Inc. | 2012-02-07 |
| TLINK DATA MANAGEMENT SYSTEM (DMS) (K113214) | Terumo Cardiovascular Systems Corp. | 2012-02-07 |
| SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS (K112591) | Safe Secure Packaging Co., Ltd. | 2012-02-07 |
| ORTHO-1(NOT FINALIZED) (K113401) | Bisco, Inc. | 2012-02-07 |
| Z FLEX-270TM STEERABLE SHEATH (K112541) | Great Batch Medical | 2012-02-07 |
| CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS (K111481) | Corin USA | 2012-02-06 |
| POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K113100) | Maxter Glove Manufacturing Sdn Bhd | 2012-02-06 |
| METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET (K113752) | Solana Surgical, LLC | 2012-02-06 |
| PATIENT MONITOR (K113653) | Edan Instruments, Inc. | 2012-02-06 |
| AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE (K111959) | Aesculap, Inc. | 2012-02-06 |
| AQUILEX FLUID CONTROL SYSTEM H112 (K112642) | W.O.M. World of Medicine AG | 2012-02-06 |
| ZIO PATCH (K113862) | iRhythm Technologies, Inc. | 2012-02-06 |
| VASCULAR SONO (K113196) | PAJUNK GmbH Medizintechnologie | 2012-02-06 |
| CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM (K113762) | Arthrosurface, Inc. | 2012-02-06 |
| NAVIAID ICVI-F,S,B,R DEVICE (K112106) | Smart Medical Systems , Ltd. | 2012-02-06 |
| FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM (K111890) | Taidoc Technology Corporation | 2012-02-06 |
| PATHWAY AVID (K111726) | Custom Spine, Inc. | 2012-02-06 |
| ROTOR-GENE Q MDX (K113319) | QIAGEN GmbH | 2012-02-06 |
| ARTUS INFL A/B RG RT-PCR KIT (K113323) | QIAGEN GmbH | 2012-02-06 |
| PERIMETER INTERBODY FUSION DEVICE (K113642) | Medtronic Sofamor Danek USA | 2012-02-06 |
| HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET (K120029) | Solana Surgical, LLC | 2012-02-06 |
| ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE (K113716) | Asahi Intecc Co., Ltd. | 2012-02-06 |
| REST ASSURED GENERATION III DENTAL PROTECTOR (K120103) | Ranir, LLC | 2012-02-03 |
| AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS (K113334) | Opal Orthodontics by Ultradent Products, Inc. | 2012-02-03 |
| CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) (K120068) | Conformis, Inc. | 2012-02-03 |
| S-MINI IMPLANT SYSTEM (K112540) | Neobiotech Co., Ltd. | 2012-02-03 |
| IDS-ISYS INTACT PTH (K103325) | Immunodiagnostic Systems , Ltd. | 2012-02-03 |
| PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD (K111684) | Playtex Manufacturing, Inc. | 2012-02-03 |
| BRIGHT EMBRACE MODEL SBL60 (K110550) | Physician Engineered Products, Inc. | 2012-02-03 |
| PIEZOTOME SOLO (K112188) | Satelec - Acteon, Inc. | 2012-02-03 |
| CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE (K113359) | Chison Medical Imaging Co., Ltd. | 2012-02-03 |
| CORAL SPINAL SYSTEM (K120047) | Theken Spine, LLC | 2012-02-03 |
| MANTARAY CATHETER (K120129) | Bridgepoint Medical | 2012-02-03 |
| CONTOUR HEALER (K112099) | Contour Healer, LLC | 2012-02-03 |
| TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS (K112953) | Teratech Corp. | 2012-02-03 |
| CONSERVE THIN SHELL (K113322) | Wrightmedicaltechnologyinc | 2012-02-03 |
| CMAP PRO (K113074) | Medical Technologies, Inc. | 2012-02-02 |
| FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM (K120017) | Fresenius Medical Care North America | 2012-02-02 |
| HERO GRAFT (K120006) | Hemosphere, Inc. | 2012-02-02 |
| NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM (K112976) | Hartalega Snd. Bhd. | 2012-02-02 |
| RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT (K110051) | Great Batch Medical | 2012-02-02 |
| APC FLASH-FREE ADHESIVE (K113197) | 3M Unitek Corporation | 2012-02-02 |
| MINI-MEDIC (K113165) | Athena Gtx | 2012-02-02 |
| SAVANNAH TECHNOLOGIES SPINAL SYSTEM (K113755) | Savannah Technologies, LLC | 2012-02-01 |
| GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT (K110899) | Gold Standard Diagnostics | 2012-02-01 |
| QUICKSCREEN COCAINE 150 SCREENING TEST (K103295) | Phamatech, Inc. | 2012-02-01 |
| BRUNO ELAN STAIRWAY ELEVATOR (K113308) | Bruno Independent Living Aids, Inc. | 2012-02-01 |
| EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 (K112074) | Everyway Medical Instruments Co.,Ltd | 2012-02-01 |
| KLASSIC KNEE SYSTEM (K112906) | Total Joint Orthopedics, Inc. | 2012-02-01 |
| FREEMIE (R) (K111411) | Dao Health | 2012-02-01 |
| SYNTHES USS CONNECTORS (K113149) | Synthes Spine | 2012-02-01 |
| SPSMEDICAL SPORVIEW STEAM BI (K111515) | Spsmedical Supply Corp. | 2012-02-01 |
| QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) (K113744) | Angiotech | 2012-02-01 |
| ONE PERSONAL LUBRICANT (WATER BASED) (K110691) | One | 2012-02-01 |