| DMS 300-2, 300-3 AND 300-4 (K062959) | Diagnostic Monitoring Software | 2006-10-16 |
| NET-2000 MICROCURRENT STIMULATOR (K060158) | Auri-Stem Medical, Inc. | 2006-10-13 |
| COLOPLAST OSTOMY ROD, MODEL 12814 (K052229) | Coloplast Corp. | 2006-10-13 |
| DEPUY LPS PROXIMAL TIBIAL COMPONENT (K062301) | DePuy Orthopaedics, Inc. | 2006-10-13 |
| HABIB 4X LAPAROSCOPIC (K062935) | Rita Medical Systems | 2006-10-13 |
| CTL-63 AND CTL-128 SPINE ARRAY COILS (K062767) | Invivo Corporation | 2006-10-13 |
| MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300 (K060669) | Healthonics, Inc. | 2006-10-13 |
| CONFORM (K062157) | Apex Dental Materials, Inc. | 2006-10-13 |
| SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT (K062697) | Cook Biotech, Inc. | 2006-10-13 |
| HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR (K061070) | Hansen Medical, Inc. | 2006-10-13 |
| LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT (K062808) | Catch Incorporated | 2006-10-13 |
| CR 85-X (K062742) | Agfa Corporation | 2006-10-13 |
| PRE' VAGINAL LUBRICANT (K051436) | Ingfertlity, LLC | 2006-10-13 |
| VERESS CANNULA AND MODULAR VERESS CANNULA (K062097) | PAJUNK GmbH Medizintechnologie | 2006-10-13 |
| SURGISIS, SURGISIS ES (K062696) | Cook Biotech, Inc. | 2006-10-13 |
| WALLACE ARTIFICIAL INSEMINATION CATHETER (K061679) | Irvine Scientific Sales Co., Inc. | 2006-10-13 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K062681) | Trek Diagnostic Systems, Ltd. | 2006-10-13 |
| MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN (K062773) | Dade Behring, Inc. | 2006-10-13 |
| XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII (K062895) | Dutch Ophthalmic Research Center International BV | 2006-10-13 |
| COLLAGEN DENTAL MEMBRANE III (K062846) | Collagen Matrix, Inc. | 2006-10-13 |
| MODIFICATION TO ENDO-EASE (K062805) | Spirus Medical, Inc. | 2006-10-13 |
| MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) (K062923) | Dade Behring, Inc. | 2006-10-13 |
| APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM (K061413) | Gen-Probe, Inc. | 2006-10-13 |
| PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS (K062972) | Roche Diagnostics Corp. | 2006-10-13 |
| HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM (K062495) | Depuy Spine, Inc. | 2006-10-13 |
| STELLARTECH 100 COAGULATION SYSTEM (K061544) | Stellartech Research Corp. | 2006-10-13 |
| NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL (K062768) | Zimmer, Inc. | 2006-10-13 |
| THERMASSAGE (K061001) | Thermage, Inc. | 2006-10-12 |
| INTROL CF PANEL I CONTROL (DEN060007) | Maine Molecular Quality Controls, Inc. | 2006-10-12 |
| ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810 (K062144) | Invivo Corporation | 2006-10-12 |
| MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) (K062927) | Dade Behring, Inc. | 2006-10-12 |
| CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 (K061046) | Cardiomems, Inc. | 2006-10-12 |
| MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR (K060458) | Langford IC Systems, Inc. | 2006-10-12 |
| ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S (K061847) | Zimmer Dental, Inc. | 2006-10-12 |
| CARDIOFLON, CARDIOXYL (K060163) | Peters Surgical | 2006-10-11 |
| MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS (K062663) | Moldex/Metric, Inc. | 2006-10-11 |
| WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E (K062790) | Wu'S Tech Co., Ltd. | 2006-10-11 |
| CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE (K062727) | Medtronic Vascular | 2006-10-11 |
| SINCLAIR SEBORRHEA EMULSION (K050158) | Sinclair Pharmaceuticals, Ltd. | 2006-10-11 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K062520) | Jiangsu Jaysun Glove Co., Ltd. | 2006-10-11 |
| TRIO + SPINAL SYSTEM (K062698) | Stryker Spine | 2006-10-11 |
| COLLAGEN DENTAL MENBRANE - CONFORMABLE II (K062881) | Collagen Matrix, Inc. | 2006-10-11 |
| VANGUARD REPROCESSED SUTURE PASSER (K053585) | Ascent Healthcare Solutions | 2006-10-11 |
| MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER (K053538) | Curapharm, Inc. | 2006-10-10 |
| STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE (K061660) | Stryker Instruments | 2006-10-10 |
| GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 (K061417) | Genicon | 2006-10-10 |
| SURGISIS RVP RECTO-VAGINAL FISTULA PLUG (K062729) | Cook Biotech, Inc. | 2006-10-10 |
| MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN (K062777) | Dade Behring, Inc. | 2006-10-10 |
| KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 (K062309) | Karma Medical Products Co., Ltd. | 2006-10-10 |
| BASX BLADELESS TROCAR (K062209) | Ethicon Endo-Surgery, LLC | 2006-10-10 |
| STARION INSTRUMENTS THERMAL LITIGATING SHEARS (K062257) | Starion Instruments | 2006-10-10 |
| DIACHEX BLOOD GLUCOSE MONITORING SYSTEM (K062829) | Tyson Bioresearch, Inc. | 2006-10-10 |
| MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER (K062421) | Mentor Corporation | 2006-10-10 |
| BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568 (K060538) | Beaverite International Limited | 2006-10-10 |
| ACCESS EPO ASSAY (K052223) | Beckman Coulter, Inc. | 2006-10-06 |
| MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 (K050197) | Minitube of America, Inc. | 2006-10-06 |
| MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM (K062302) | Millicore AB | 2006-10-06 |
| D-STAT DRY HEMOSTATIC BANDAGE (K061219) | Vascular Solutions, Inc. | 2006-10-06 |
| SILVERLON CA (CALCIUM ALGINATE) (K053590) | Argentum Medical, LLC | 2006-10-06 |
| MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER (K062609) | AngioDynamics, Inc. | 2006-10-06 |
| ORTHOXP (K062634) | Imaging Dynamics Company , Ltd. | 2006-10-06 |
| CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES (K060927) | Ceres Medical Systems, LLC | 2006-10-06 |
| PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM (K061362) | Plus Orthopedics AG | 2006-10-06 |
| EBI ARAY SPINAL SYSTEM (K062685) | Ebi, L.P. | 2006-10-06 |
| 5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510 (K062054) | Eizo Nanao Corporation | 2006-10-06 |
| ZERION ALPHA, ; ZERION BETA (K061804) | Etkon International GmbH | 2006-10-06 |
| TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS (K061614) | Escada International, Inc. | 2006-10-06 |
| FLEXITOUCH SYSTEM (K062818) | Tactile Systems Technology, Inc. | 2006-10-06 |
| PASS 2 SPINAL SYSTEM (K062136) | Medicrea | 2006-10-06 |
| RTVUE (K062552) | Optovue, Inc. | 2006-10-06 |
| ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 (K061232) | Acrymed, Inc. | 2006-10-06 |
| EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT (K061408) | Euroimmun Us, LLC | 2006-10-05 |
| OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 (K061575) | Olympus America, Inc. | 2006-10-05 |
| UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM (K062686) | Advanced Spine Technology, Inc. | 2006-10-05 |
| ACCUSOFT, ACCUSOFT XL (K062032) | Direx Systems Corp. | 2006-10-05 |
| URASSIST (K062061) | Preferred Medical Devices, Inc. | 2006-10-05 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML (K062680) | Becton, Dickinson & CO | 2006-10-05 |
| ECHELON SHOULDER COIL (K062556) | Hitachi Medical Systems America, Inc. | 2006-10-05 |
| KMI CEMENT RESTRICTOR IMPLANT (K061465) | Kinetikos Medical, Inc. | 2006-10-05 |
| OPTICATH CENTRAL VENOUS OXIMETRY CATHETER (K061585) | Hospira, Inc. | 2006-10-05 |
| TREASURE (K061984) | Asahi Intecc Co., Ltd. | 2006-10-05 |
| ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) (K062516) | Beckman Coulter, Inc. | 2006-10-05 |
| NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS (K062730) | Biogreen Medical Sdn. Bhd. | 2006-10-05 |
| ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES (K062047) | PAJUNK GmbH Medizintechnologie | 2006-10-05 |
| VASORING* VRC VASCULAR RING CONNECTOR (K061626) | Sunwei Tech Co. , Ltd. | 2006-10-05 |
| BRANSIST SAFIRE (K062360) | Shimadzu Corp. | 2006-10-05 |
| SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM (K062387) | Boston Scientific | 2006-10-05 |
| POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE (K062138) | Molnlycke Health Care, Inc. | 2006-10-05 |
| QANGIO CT (K062386) | Medis Medical Imaging Systems BV | 2006-10-05 |
| DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) (K062779) | New Wave Surgical Corporation | 2006-10-05 |
| SYNGO DUAL ENERGY (K062351) | Siemens Medical Solutions USA, Inc. | 2006-10-05 |
| MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR (K062337) | Aaron Medical Industries | 2006-10-05 |
| BELMAX CM MODEL X168 (K062529) | Takara Belmont USA, Inc. | 2006-10-05 |
| DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL (K062035) | Dade Behring, Inc. | 2006-10-04 |
| MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM (K062617) | Inion , Ltd. | 2006-10-04 |
| SMARTSUCTION SOLO DEVICE (K062801) | Haemonetics Corp. | 2006-10-04 |
| PREMIER SELF-ETCHING BOND ENHANCER (K061998) | Premier Dental Products Co. | 2006-10-04 |
| V.A.C. THERAPY SYSTEM (K062227) | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2006-10-04 |
| KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 (K062311) | Karma Medical Products Co., Ltd. | 2006-10-04 |
| COULTER LH 780 HEMATOLOGY ANALYZER (K061616) | Beckman Coulter, Inc. | 2006-10-04 |