| SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B (K062948) | Cepheid | 2006-12-08 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML (K063301) | Becton, Dickinson & CO | 2006-12-08 |
| GE DATEX-OHMEDA ENGSTROM CARESTATION (K062710) | Datex-Ohmeda, Inc. | 2006-12-08 |
| RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE (K062707) | Innovative Endoscopy Components, LLC | 2006-12-08 |
| EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES (K063214) | Ever Light Plastic Products Co., Ltd. | 2006-12-08 |
| MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE (K063366) | Dade Behring, Inc. | 2006-12-08 |
| SHANGHAI GANGHAI MODEL GIKO 1400 (K063334) | Shanghai Gangkai Purifying Products Co., Ltd. | 2006-12-08 |
| MEDTRONIC GRAFT DELIVERY SYRINGE (K062986) | Medtronic Sofamor Danek USA, Inc. | 2006-12-08 |
| BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062213) | Bio-Rad Laboratories, Inc. | 2006-12-08 |
| ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS (K062997) | Biomet Manufacturing Corp | 2006-12-08 |
| MINISCREWS ANCHORING SYSTEM, M.A.S. (K062367) | Micerium S.P.A. | 2006-12-08 |
| MANUAL PD-IO; POWERED PD-IO (K063142) | Vidacare Corporation | 2006-12-08 |
| EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K063215) | Ever Light Plastic Products Co., Ltd. | 2006-12-08 |
| THERACAL LC (K063237) | Bisco, Inc. | 2006-12-08 |
| K-Y BRAND INTRIGUE (K062796) | Personal Products Co. | 2006-12-08 |
| PRN THERMALCARE, MODEL 3000 (K062794) | American Healthcare Products, Inc. | 2006-12-07 |
| LUXVISION SLIT LAMP (K063416) | Us Ophthalmic, LLC | 2006-12-07 |
| MODIFICATION TO: SMITHWICK CAROTID SHUNT (K061484) | Mcpherson Enterprises, Inc. | 2006-12-07 |
| NOVAPACS (K063153) | Novarad Corp. | 2006-12-07 |
| ACUMED CONGRUENT BONE PLATE SYSTEM (K063460) | Acumed, LLC | 2006-12-07 |
| ABC HAIR REMOVAL SYSTEM (K060839) | Palomar Medical Technologies, Inc. | 2006-12-07 |
| THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM (K063254) | Cordis Neurovascular, Inc. | 2006-12-07 |
| 20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204) (K063200) | Totoku Electric Co., Ltd. | 2006-12-07 |
| MERCATOR MICROSYRINGE II INFUSION CATHETER (K062752) | Mercator Medsystems, Inc. | 2006-12-07 |
| ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS (K062001) | Rostam , Ltd. | 2006-12-07 |
| DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER (K061844) | Wrightmedicaltechnologyinc | 2006-12-06 |
| POWDER FREE LATEX EXAMINATION GLOVES, BLACK (K062709) | Pt. Maja Agung Latexindo | 2006-12-06 |
| BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM (K051817) | Cardiva Medical, Inc. | 2006-12-06 |
| MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1 (K062867) | Microlife Intellectual Property GmbH | 2006-12-06 |
| I-SCOPE 200 (K062364) | Dongjin Medical Co., Ltd. | 2006-12-06 |
| PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM (K061436) | Palomar Medical Technologies, Inc. | 2006-12-06 |
| G-PROX ENDOSCOPIC GRASPER (K061276) | Usgi Medical | 2006-12-06 |
| TOTAL AND HEMI SHOULDER SYSTEM (K060988) | Dvo Extremity Solutions, LLC | 2006-12-06 |
| STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM (K061805) | Diagnostica Stago, Inc. | 2006-12-06 |
| MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN (K062324) | GE Healthcare | 2006-12-06 |
| NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE (K063374) | Grace Medical, Inc. | 2006-12-06 |
| NOBELREPLACE TAPERED CONICAL CONNECTION (K062566) | Nobel Biocare USA, LLC | 2006-12-06 |
| HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 (K062664) | Apex Medical Corp. | 2006-12-06 |
| VERITAS COLLAGEN MATRIX (K062915) | Synovis Surgical Innovations | 2006-12-06 |
| DC-6 DIAGNOSTIC ULTRASOUND SYSTEM (K063500) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-12-06 |
| IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (K063045) | Diagnostic Products Corp. | 2006-12-05 |
| EZ-MIO, EZ-IO DISTAL TIBIA (K062956) | Vidacare Corporation | 2006-12-05 |
| ESA LEADCARE II LEAD CONTROL (K063398) | Bionostics, Inc. | 2006-12-05 |
| URITEST 10 URINALYSIS REAGENT STRIPS (K052719) | Arj Medical, Inc. | 2006-12-05 |
| FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) (K063313) | Boston Scientific Corp | 2006-12-05 |
| REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS (K062435) | Spire Biomedical, Inc. | 2006-12-05 |
| NEUROWAVE MICRO-INFUSION SYSTEM (K062508) | Ekos Corp. | 2006-12-05 |
| ARJOWRAP 47/100 AND 47/88 (K062100) | Arjo Wiggins Medical, Inc. | 2006-12-05 |
| TRUEHD (1080P) DIGITAL CAMERA SYSTEM (K063457) | Conmed Linvatec | 2006-12-05 |
| EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K063213) | Ever Light Plastic Products Co., Ltd. | 2006-12-05 |
| DEMETRON A.2 (K063116) | Sybron Dental Specialties | 2006-12-05 |
| BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY (K062819) | Bioplate, Inc. | 2006-12-04 |
| EDIA ANTI-CCP (K062045) | Euro-Diagnostica AB | 2006-12-04 |
| 21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2) (K063199) | Totoku Electric Co., Ltd. | 2006-12-04 |
| MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) (K063419) | Welch Allyn Protocol, Inc. | 2006-12-04 |
| INTIMOL (K061466) | Dlc Laboratories, Inc. | 2006-12-04 |
| CELERITY (K062518) | Parkell, Inc. | 2006-12-04 |
| TUFFLEX POLYESTER SUTURE (K063194) | Axya Medical, Inc. | 2006-12-04 |
| WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 (K062750) | Boston Scientific Corp | 2006-12-04 |
| TWIST DRILL (K062842) | Walter Lorenz Surgical, Inc. | 2006-12-04 |
| PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 (K062769) | Radi Medical Systems AB | 2006-12-04 |
| PREVIEW ANTERIOR CERVICAL PLATE SYSTEM (K062371) | Alphaspine, Inc. | 2006-12-04 |
| COMFORT SCOOTER MODEL LY-EW406 (K063030) | Comfort Orthopedic Co., Ltd. | 2006-12-04 |
| ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 (K063308) | Carbylan Biosurgery | 2006-12-04 |
| LSC, MODEL 3 (K061726) | Lifestand | 2006-12-04 |
| MEDICAN ALPHA (K063469) | Eastern Medikit , Ltd. | 2006-12-01 |
| GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES (K062719) | Laserscope | 2006-12-01 |
| NCONTACT COAGULATION SYSTEM KIT, MODEL CSK (K063012) | Ncontact Surgical, Inc. | 2006-12-01 |
| CONSERVE FEMORAL RESURFACING COMPONENT (K062960) | Wrightmedicaltechnologyinc | 2006-12-01 |
| ILLUMIMED (K060792) | Photoactif, LLC | 2006-12-01 |
| LOGIC LAPAROSCOPIC SCISSORS (K063485) | Surgical Innovations Plc | 2006-12-01 |
| MISSION TRINITY B (K062674) | Diamond Diagnostics, Inc. | 2006-12-01 |
| HKBOND 2006 (K063062) | Heraeus Kulzer, Inc. | 2006-12-01 |
| NCONTACT COAGULATION SYSTEM KIT (K062539) | Ncontact Surgical, Inc. | 2006-12-01 |
| PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S (K063013) | Aearo Company | 2006-12-01 |
| COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON (K061937) | Cook Endoscopy | 2006-12-01 |
| DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 (K063220) | Intuitive Surgical, Inc. | 2006-12-01 |
| LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420, (K063025) | Lina Medical Aps | 2006-12-01 |
| ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS (K063538) | Arthrocare Corp. | 2006-12-01 |
| SPIROBANK II (K061712) | Mir Medical Intl. Research Srl | 2006-12-01 |
| DYNAMIC GAS SCAVENGING SYSTEM (DGSS) (K063519) | Anesthetic Gas Reclamation, LLC | 2006-12-01 |
| REVLITE Q-SWITCHED ND:YAG LASER (K063112) | Hoya Conbio, Inc. | 2006-12-01 |
| VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 (K063400) | Bio-Rad Laboratories, Inc. | 2006-12-01 |
| EMG AC/DC SUCTION UNIT (K063448) | Emg Technology Co., Ltd. | 2006-11-30 |
| DEL-IMS (K063188) | Del Medical Imaging Corp. | 2006-11-30 |
| MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS (K063342) | Medrad, Inc. | 2006-11-30 |
| VASOPRESS DVT SYSTEM, MODEL VP500D (K061814) | Compression Therapy Concepts, Inc. | 2006-11-30 |
| SYNGO NEURO PBV CT (K063507) | Siemens AG | 2006-11-30 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) (K062271) | Philips Medical Systems | 2006-11-30 |
| 21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2) (K063198) | Totoku Electric Co., Ltd. | 2006-11-30 |
| MAPMATE (K063277) | Ep Medsystems, Inc. | 2006-11-30 |
| SPECTRAL WEST NILE VIRUS IGM STATUS TEST (K052519) | Spectral Diagnostics, Inc. | 2006-11-30 |
| POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM (K062833) | Vidacare Corporation | 2006-11-30 |
| SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (K062313) | Pt Mahakarya Inti Buana | 2006-11-30 |
| MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD (K062748) | DePuy Orthopaedics, Inc. | 2006-11-30 |
| RAPID STRAND RX (K063177) | Oncura, Inc. | 2006-11-30 |
| MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 (K063312) | Boston Scientific Corp | 2006-11-30 |
| CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM (K062340) | Cardio-Optics, Inc. | 2006-11-30 |
| SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM (K062589) | Inolase 2002, Ltd. | 2006-11-30 |
| POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (K062688) | Ug Healthcare (Usa), Inc. | 2006-11-30 |