| CONNEXALL SUITE OF SOFTWARE PRODUCTS (K112650) | Connexall USA, Inc. | 2012-02-01 |
| PASS LP SPINAL (K112736) | Medicrea International | 2012-02-01 |
| PATIENT MONITOR (K113623) | Edan Instruments, Inc. | 2012-02-01 |
| HAPTITE COATING IMPLANT SYSTEM (K111364) | Dentis Co., Ltd. | 2012-02-01 |
| BIPAP A 30 VENTILATORY SUPPORT SYSTEM (K113053) | Respironics, Inc. | 2012-02-01 |
| UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W (K111305) | Meridian Medical Systems, LLC | 2012-01-31 |
| ACTIVECARE DVT ACTIVECARE+SFT (K113525) | Medical Compression Systems (Dbn) , Ltd. | 2012-01-31 |
| CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS (K113014) | Wrightmedicaltechnologyinc | 2012-01-31 |
| TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS (K112526) | Smith & Nephew, Inc. | 2012-01-31 |
| AUDIT MICROCV T-UPTAKE LINEARITY (K112143) | Aalto Scientific, Ltd. | 2012-01-31 |
| TRANSTEK BLOOD PRESSURE MONITOR (K120058) | Zhongshan Transtek Electronics Co., Ltd. | 2012-01-31 |
| SMART READ EZTEST STEAM (K112018) | Mesa Laboratories, Inc. | 2012-01-30 |
| AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE (K113555) | Am USA | 2012-01-30 |
| BIOGEL (R) INDICATOR (R) UNDERGLOVE (K111413) | Molnlycke Health Care Us, LLC | 2012-01-30 |
| CLARITY OBP SYSTEM (K111332) | Elekta , Ltd. | 2012-01-30 |
| CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE (K112539) | Leiker Regulatory & Quality Consulting | 2012-01-30 |
| ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT (K112600) | AngioDynamics, Inc. | 2012-01-30 |
| CAAS A-VALVE (K113076) | Pie Medical Imaging BV | 2012-01-30 |
| ALDAHOL V HIGH LEVEL DISINFECTANT (K113015) | Microchem Laboratories, Inc. | 2012-01-30 |
| GLUCOSE METER-CHECK SOLUTION FOR INFOPIA (K113764) | Bionostics, Inc. | 2012-01-30 |
| LRT ATTACHMENT (K112333) | Bcf Certification, Inc. | 2012-01-30 |
| MAXLOCK EXTREME SYSTEM (K113048) | Orthohelix Surgical Designs, Inc. | 2012-01-30 |
| MCKESSON HORIZON CARDIOLOGY (K112720) | Mckesson Israel , Ltd. | 2012-01-30 |
| DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE (K111385) | Qubyx Limited | 2012-01-30 |
| BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS (K112875) | Blue Sky Bio, LLC | 2012-01-27 |
| MODEL HBP-1300 (K113185) | Omron Healthcare, Inc. | 2012-01-27 |
| ELECTRO-CAP SYSTEM (K112319) | Electro-Cap Intl., Inc. | 2012-01-27 |
| MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1 (K113141) | Microlife Intellectual Property GmbH | 2012-01-27 |
| NCB STRAIGHT NARROW SHAFT PLATES (K113718) | Zimmer GmbH | 2012-01-27 |
| NEUMOVENT GRAPHNET (K111595) | Tecme S.A. | 2012-01-27 |
| NNC GOLD ABUTMENT FOR BRIDGES (K113606) | Straumann USA | 2012-01-27 |
| MICRODOT & MICRODOT XTRA (K102383) | Cambridge Sensors Limited | 2012-01-27 |
| CATHETER CONNECTIONS' DUALCAP SOLO (K113842) | Catheter Connections, Inc. | 2012-01-27 |
| SPOTLIGHT ACCESS SYSTEM (K113273) | Johnson & Johnson | 2012-01-27 |
| SANTORINI SPINAL SYSTEM (K111294) | K2m, Inc. | 2012-01-27 |
| SOCKET GRAFT (K113049) | Steiner Laboratories | 2012-01-27 |
| VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT (K113524) | Maine Standards Co. | 2012-01-27 |
| BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE (K112233) | Bovie Medical Corporation | 2012-01-27 |
| FINGERTIP PULSE OXIMETER (K112804) | Guangdong Biolight Meditech Co., Ltd. | 2012-01-27 |
| REST ASSURED READY TO WEAR NITE PROTECTOR (K112879) | Ranir, LLC | 2012-01-27 |
| GMK RESUFACING PATELLA SIZE 4 (K113571) | Medacta International | 2012-01-27 |
| PATHASSIST LIGHT SEEKER (K113522) | Entellus Medical, Inc. | 2012-01-27 |
| VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM (K113486) | Volcano Corporation | 2012-01-27 |
| RISE SPACER (K113447) | Globus Medical, Inc. | 2012-01-26 |
| AQUILION PRIME (K110066) | Toshiba America Medical Systems, In.C | 2012-01-26 |
| PILOT TUBE REPAIR KIT (K113644) | Instrumentation Industries, Inc. | 2012-01-26 |
| CALG-STR EXERCISE ECG ANALYSIS ALGORITHM (K112959) | Philips Health Care | 2012-01-26 |
| NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K111134) | Siem Aempemed Corp., Ltd. | 2012-01-26 |
| HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM (K111786) | Stryker Corp. | 2012-01-26 |
| INFX-8000V WITH (K120073) | Toshibamedical Systems Corporation | 2012-01-26 |
| AM-6000 ANESTHESIA MACHINE (K120075) | Advanced Instrumentations, Inc. | 2012-01-26 |
| CYNOSURE CELLULAZE LASER (K102541) | Cynosure, Inc. | 2012-01-26 |
| FORE-SIGHT ABSOLUTE TISSUE OXIMETER (K112820) | Cas Medical Systems, Inc. | 2012-01-26 |
| PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM (K113218) | Pioneer Surgical Technology, Inc. | 2012-01-26 |
| GAL-1A BLOOD GLUCOSE MONITORING SYSTEM (K113208) | Apex BioTechnology Corp. | 2012-01-26 |
| CLICKFINE AUTOPROTECT PEN NEEDLE (K110312) | Ypsomed AG | 2012-01-26 |
| GIZA(R) VERTEBRAL BODY REPLACEMENT (K112429) | Eden Spine, LLC | 2012-01-26 |
| GAP ENDO-EXO MEDULLARY SYSTEM (K111232) | Pega Medical, Inc. | 2012-01-26 |
| SIMPLELINE II ABUTMENT SYSTEM (K112045) | Dentium Co., Ltd. | 2012-01-26 |
| LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM (K111986) | Surgical Innovations Plc | 2012-01-26 |
| LOGICSCAN 64 LOGICSCAN 128 (K113184) | Telemed | 2012-01-26 |
| SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE (K113030) | Spineology, Inc. | 2012-01-26 |
| BICARB MIXING AND DISTRIBUTION SYSTEM (K112427) | Isopure, Corp. | 2012-01-26 |
| ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A (K112044) | Anaxdent GmbH | 2012-01-26 |
| DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K113632) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2012-01-25 |
| CARDIFF ANTERIOR CERVICAL PLATE SYSTEM (K112206) | Seaspine, Inc. | 2012-01-25 |
| TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (K113845) | Medtronic, Inc. | 2012-01-25 |
| SONIXTABLET ULTRASOUND SCANNER (K113663) | Ultrasonix Medical Corporation | 2012-01-25 |
| SWISSMEDA DENTAL PLANNING SYSTEM (K112251) | Swissmeda AG | 2012-01-25 |
| THERATRODE (K112312) | Phoenix Medical Devices, Llp | 2012-01-25 |
| SUN 125C IONIZATION CHAMBER (K112981) | Sun Nuclear Corp. | 2012-01-25 |
| ENDOCHOICE WATER BOTTLE CAP SYSTEM (K112576) | Endochoice, Inc. | 2012-01-25 |
| TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD (K111337) | Tornier, Inc. | 2012-01-25 |
| XENON(TM) PEDICLE SCREW SYSTEM (K111634) | Alphatec Spine, Inc. | 2012-01-25 |
| PANORAD, PANORAD SL (K113855) | Imix Adr Finland OY | 2012-01-25 |
| COBAS 4800 CT / NG TEST (K110923) | Roche Molecular Systems, Inc. | 2012-01-24 |
| AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL (K112705) | Aalto Scientific, Ltd. | 2012-01-24 |
| CONTIPLEX FX (K113059) | B.Braun Medical, Inc. | 2012-01-24 |
| EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION (K111877) | Bausch & Lomb, Inc. | 2012-01-24 |
| MTF NEW BONE VOILD FILLER (K113167) | Musculoskeletal Transplant Foundation | 2012-01-24 |
| IVAS BALLOON CATHETER (K113154) | Stryker Corporation | 2012-01-24 |
| MEGABEAM ENDO-ENT PROBE (K113858) | Biolitec Medical Devices, Inc. | 2012-01-24 |
| GENESIS TOUCH SYSTEM (K112858) | Honeywell Hommed, LLC | 2012-01-24 |
| STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS (K112904) | Case Medical, Inc. | 2012-01-24 |
| PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT (K112574) | Prime Dental Manufacturing, Inc. | 2012-01-23 |
| RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 (K110534) | Randox Laboratories Limited | 2012-01-23 |
| LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS (K113661) | Lin-Zhi International, Inc. | 2012-01-23 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (K112808) | Omega Laboratories, Inc. | 2012-01-23 |
| PCXX VARNISH (K113146) | Ross Healthcare, Inc. | 2012-01-23 |
| SYNDE-LOCK SYNDESMOSIS REPAIR KIT (K111971) | Tarsus Medical, Inc. | 2012-01-23 |
| CONCENPIECE,HIGH-SPEED HANDPIECE SERIES (K113301) | Dentalez, Inc. | 2012-01-23 |
| ZIMMER CONTOUR PROVISIONAL COPING (K113092) | Zimmer Dental, Inc. | 2012-01-23 |
| SURGICAL TISSUE MANAGEMENT SYSTEM (K111202) | Olympus Medical Systems Corp. | 2012-01-20 |
| STRATIFY JCV(TM) ANTIBODY (DEN120008) | Focus Diagnostics, Inc. | 2012-01-20 |
| QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE (K113800) | Angiotech | 2012-01-20 |
| SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM (K112936) | Rexam Consummer Plastics Inc.D/B/A Rexam Pharma | 2012-01-20 |
| NEUROTECH RECOVERY (K112934) | Bio-Medical Research, Ltd. | 2012-01-20 |
| DURABLUE STERILIZATION (AMSCO V-PRO) WRAP (K112918) | Cardinal Health200, LLC | 2012-01-20 |
| LIAISON 25 OH VITAMIN D TOTAL ASSAY (K112725) | DiaSorin, Inc. | 2012-01-20 |
| ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR (K110874) | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 |