| XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 (K062549) | Excel Tech. , Ltd. | 2006-10-04 |
| ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS (K061005) | Applied Dna Technologies, Inc. | 2006-10-04 |
| TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 (K061509) | Gen-Probe, Inc. | 2006-10-04 |
| PREMIER SELF-ETCHING ENAMEL SEALANT (K061997) | Premier Dental Products Co. | 2006-10-04 |
| SOLAR REUNION FRACTURE STEM (K062113) | Howmedica Osteonics Corp. | 2006-10-03 |
| MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER (K062751) | Quantimetrix Corp. | 2006-10-03 |
| SBI TRIHEDRON MTP HEMI GT (K062040) | Small Bone Innovations, Inc. | 2006-10-03 |
| SANDMAN POCKET (K061996) | Eb Neuro S.P.A. | 2006-10-03 |
| MEDICAL COMPRESSOR, MODELS DK50 D AND DM (K060781) | Ekom S.R.O. | 2006-10-03 |
| SPERMSLOW (K061145) | Medicult A/S | 2006-10-02 |
| ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP (K062180) | Horiba Abx | 2006-10-02 |
| OPTIME, SINUSORB PGA (K062366) | Peters Surgical | 2006-10-02 |
| SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 (K062320) | Cook Biotech, Inc. | 2006-10-02 |
| GRANDIO SEAL (K062344) | Voco GmbH | 2006-10-02 |
| OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR (K062244) | Arthrocare Corp. | 2006-10-02 |
| COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID (K061746) | Innocoll Pharmaceuticals | 2006-10-02 |
| DLM112 DAYLINK MONITOR (K062304) | Rtx Healthcare A/S | 2006-09-29 |
| ZIRKONZAHN ICE (K061851) | Zirkonzahn GmbH | 2006-09-29 |
| INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 (K052870) | Kimberly-Clark Corp. | 2006-09-29 |
| GLADIATOR BIPOLAR SYSTEM (K062693) | Wrightmedicaltechnologyinc | 2006-09-29 |
| VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 (K062501) | Maine Standards Co. | 2006-09-29 |
| NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L (K062462) | Jawon Medical Co., Ltd. | 2006-09-29 |
| MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 (K062095) | Spacelabs Medical, Inc. | 2006-09-29 |
| ARTHREX ASPIRATE KIT (K062365) | Arthrex, Inc. | 2006-09-29 |
| MINI-YAG LASER (K061850) | American Lasers, Inc. | 2006-09-29 |
| MULTICATH EXPERT (K061250) | Vygon Corp. | 2006-09-29 |
| CLIRPATH TURBO PERIPHERAL CATHETERS (K060012) | Spectranetics Corp. | 2006-09-29 |
| CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 (K061568) | Codman & Shurtleff, Inc. | 2006-09-29 |
| DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES (K062576) | GE Healthcare | 2006-09-29 |
| DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS (K062654) | DePuy Orthopaedics, Inc. | 2006-09-29 |
| ACUMED LASER, MODEL 1000 (K060153) | Laser Thera, LLC | 2006-09-29 |
| XPLORER 1600 PLUS (K062586) | Imaging Dynamics Company , Ltd. | 2006-09-29 |
| SPECTRA SYSTEM (K061319) | Implant Direct, LLC | 2006-09-29 |
| METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS (K062242) | Lin-Zhi International, Inc. | 2006-09-29 |
| ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM (K062747) | Arthrex, Inc. | 2006-09-29 |
| ABX PENTRA 400 : CRP (K061138) | Horiba Abx | 2006-09-29 |
| VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS (K062428) | Tripath Imaging, Inc. | 2006-09-29 |
| MAXIFLEX-SEMI FLEX SCOPE (K062725) | Technology Delivery Systems, Inc. | 2006-09-29 |
| TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 (K061942) | GE Healthcare | 2006-09-29 |
| PULSE OXIMETER ADAPTER CABLES (K052544) | American I.V. Products, Inc. | 2006-09-29 |
| PROMETEY, MODEL G1-03 (K062071) | Spectrum International | 2006-09-28 |
| V-2200 INFANT INCUBATOR (K061856) | Atom Medical, Inc. | 2006-09-28 |
| NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM (K062451) | Neusoft Medical Systems Co., Ltd. | 2006-09-28 |
| MP-1 MICROPERIMETER (K061768) | Nidek Technologies Srl | 2006-09-28 |
| CYTORI CELUTION CELL CONCENTRATION DEVICE (K060482) | Cytori Therapeutics, Inc. | 2006-09-28 |
| MODIFICATION TO LUCAS (K062401) | Jolife AB | 2006-09-28 |
| MODIFICATION TO STOCKERT S5 SYSTEM (K062396) | Sorin Group Deutschland GmbH | 2006-09-28 |
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM (K062514) | Accuray Incorporated | 2006-09-28 |
| CARE-E-VAC 3 (K062610) | Ohio Medical Corporation | 2006-09-28 |
| CLEARFIL CERAMIC PRIMER (K061906) | Kuraray Medical, Inc. | 2006-09-28 |
| STRYKER URETERAL ILLUMINATION SYSTEM IV (K061548) | Stryker Corp. | 2006-09-28 |
| CHASE CARDIAC ANALYSIS SYSTEM (K062031) | Chase Medical, LP | 2006-09-27 |
| ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES (K062679) | Arthrex, Inc. | 2006-09-27 |
| OWL URF-3AP (K062758) | Diros Technology, Inc. | 2006-09-27 |
| CLEARFIL DC BOND (K062382) | Kuraray Medical, Inc. | 2006-09-27 |
| LITETOUCH DENTAL LASER SYSTEM (K061966) | Light Instrument, Ltd. | 2006-09-27 |
| BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES (K062385) | Grace Medical, Inc. | 2006-09-27 |
| MOLTENO3 (K062252) | Iop, Inc. | 2006-09-27 |
| KOWA NONMYD ALPHA-D (K062356) | Kowa Co. , Ltd. | 2006-09-27 |
| EPOC BLOOD ANALYSIS SYSTEM (K061597) | Epocal, Inc. | 2006-09-27 |
| MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH (K062429) | Edwards Lifesciences Research Medical | 2006-09-27 |
| TATTOOSTAR FAMILY (K060787) | Asclepion Laser Technologies GmbH | 2006-09-27 |
| MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS (K062599) | Integra LifeSciences Corporation | 2006-09-27 |
| CKIS-004A INJECTOR SYNCHRONIZATION OPTION (K061976) | Toshiba America Medical Systems, In.C | 2006-09-27 |
| NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES (K062505) | Abbott Spine, Inc. | 2006-09-26 |
| ISS INTEGRATED SPINE SYSTEM (K061524) | Ortho Development Corp. | 2006-09-26 |
| CLEARFIL ESTHETIC CEMENT & DC BOND (K062410) | Kuraray Medical, Inc. | 2006-09-26 |
| MAGSTIM 200-2 (K060847) | Magstim Company Us, LLC | 2006-09-26 |
| MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K062133) | Medtronic Spinal and Biologics Div | 2006-09-26 |
| SCD GARMENT, MODEL VP530 (K061967) | Compression Therapy Concepts, Inc. | 2006-09-25 |
| COOLTOUCH, MODEL CTEV (K061618) | New Star Lasers, Inc. | 2006-09-25 |
| ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE (K061776) | Arthrotek, Inc. | 2006-09-25 |
| 23 MM SINGLE-PEG PATELLA COMPONENT (K061340) | Biomet Manufacturing, Inc. | 2006-09-25 |
| ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM (K061770) | Ethicon Endo-Surgery, Inc. | 2006-09-25 |
| COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 (K062210) | New Star Lasers, Inc. | 2006-09-25 |
| TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT (K062342) | Sentra Medical Devices, LLC | 2006-09-25 |
| CD HORIZON SPINAL SYSTEM (K062606) | Medtronic Sofamor Danek | 2006-09-25 |
| DOUBLEPLAY SUTURE ANCHOR (K061949) | Biocomposites, Ltd. | 2006-09-25 |
| QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR (K062701) | Sunrise Medical, Inc. | 2006-09-25 |
| SURGICAL DRAPES (K061422) | Austin Medical, Inc. | 2006-09-25 |
| HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH (K062000) | Ethicon Endo-Surgery, Inc. | 2006-09-25 |
| DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH (K061852) | Dade Behring, Inc. | 2006-09-22 |
| STRYKER INJECTABLE CEMENT (K060763) | Stryker | 2006-09-22 |
| DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 (K062334) | Dade Behring, Inc. | 2006-09-22 |
| RESOLUTIONMD, VERSION 1.3 (K062164) | Calgary Scientific, Inc. | 2006-09-22 |
| ARCHITECT CORTISOL ASSAY (K062204) | Seradyn, Inc. | 2006-09-22 |
| SELFCHECK GLUCO (K061528) | Card Guard Scientific Survival , Ltd. | 2006-09-22 |
| ACTICAL (K060919) | Respironics, Inc. | 2006-09-22 |
| MIMVIEWER (K062163) | Mimvista Corp. | 2006-09-22 |
| KENSEY NASH BONE VOID FILLER (K060917) | Kensey Nash Corporation | 2006-09-22 |
| TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT (K062618) | Varian Medical Systems, Inc. | 2006-09-22 |
| ALLOGRAN-R (K061311) | Biocomposites, Ltd. | 2006-09-22 |
| HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 (K062119) | Medical Products Mfg., LLC | 2006-09-22 |
| PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES (K062072) | PAJUNK GmbH Medizintechnologie | 2006-09-22 |
| VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM (K061155) | Zimmer Trabecular | 2006-09-22 |
| MODIFICATION TO SYNGO INSPACE 4D (K062673) | Siemens AG Medical Solutions | 2006-09-22 |
| EVIS EXERA II 180 SYSTEM (K062049) | Olympus Medical Systems Corporation | 2006-09-22 |
| HEMOSIL HOMOCYSTEINE AND CONTROLS (K061598) | Instrumentation Laboratory CO | 2006-09-22 |
| MODIFICATION TO MYALLERGY TEST (K061979) | Immunetech Corporation | 2006-09-22 |
| ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE (K062531) | Cordis Corp., A Johnson & Johnson Co. | 2006-09-22 |