| SURGICHIP TAG SURGICAL MARKER (K042555) | Surgichip, Inc. | 2004-11-09 |
| SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX (K042537) | Invatec Innovative Technologies | 2004-11-08 |
| BEELINE MOTIV, PROPOLIS, PCA (K042228) | Mckinley, Inc. | 2004-11-08 |
| SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX (K042538) | Invatec Innovative Technologies | 2004-11-08 |
| OTOMIMIX (K042516) | Walter Lorenz Surgical, Inc. | 2004-11-08 |
| SUPERDIMENSION/BRONCHUS (K042438) | Superdimension, Ltd. | 2004-11-08 |
| SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 (K042527) | Medical Action Industries, Inc. | 2004-11-08 |
| VIVOSORB SHEET, MODEL FS01 (K042811) | Polyganics B.V., | 2004-11-08 |
| SOUTH BEACH SMILE LIGHT WHITENING SYSTEM (K042153) | Dentovations, Inc. | 2004-11-08 |
| VASC-ALERT (K042566) | Vasc-Alert, Inc. | 2004-11-08 |
| IMAGE MEDICAL ACQUISITION STATION (IMAS) (K042700) | Erad Imagemedical Corp. | 2004-11-08 |
| SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US (K041392) | CAO Group, Inc. | 2004-11-08 |
| GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 (K041239) | Genesis Medical Technology, Inc. | 2004-11-08 |
| MULTI-LIPID CALIBRATOR (K042550) | Wako Chemicals USA, Inc. | 2004-11-08 |
| MULTI CHEM CAL B (K042549) | Wako Chemicals USA, Inc. | 2004-11-08 |
| MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS (K042211) | Surgical Laser Technologies, Inc. | 2004-11-08 |
| POLARIS DS/COMET (K041959) | Syneron Medical, Ltd. | 2004-11-08 |
| MAMMOTOME MR BIOPSY SYSTEM (K042753) | Ethicon Endo-Surgery, Inc. | 2004-11-08 |
| MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K042969) | Cordis Corp. | 2004-11-08 |
| INNOJECT AUTO-INJECTOR (K042557) | Innoject, Inc. | 2004-11-08 |
| CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE (K042615) | Carbon Medical Technologies, Inc. | 2004-11-05 |
| KENDALL CO2NFIRM NOW CO2 DETECTOR (K042572) | Kendall | 2004-11-05 |
| ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE (K042796) | Coapt Systems, Inc. | 2004-11-05 |
| QUEST TUMOR MARKER CONTROL, MODEL 955 (K042815) | Bio-Rad | 2004-11-05 |
| POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM (K042230) | Cryo Vascular Systems, Inc. | 2004-11-05 |
| RANDOX BARBITURATE ASSAY (K041143) | Randox Laboratories, Ltd. | 2004-11-05 |
| TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA (K041367) | Topcon Corp. | 2004-11-05 |
| 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA (K042617) | Siemens Medical Solutions USA, Inc. | 2004-11-05 |
| K.E.P. CONNECTOR AND CLIP (K042900) | K.E.P., LLC | 2004-11-05 |
| ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) (K042874) | Possis Medical, Inc. | 2004-11-05 |
| ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT (K042619) | Sonotech, Inc. | 2004-11-05 |
| BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER (K041464) | Busse Hospital Disposables | 2004-11-05 |
| MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL (K042717) | Medical Analysis Systems, Inc. | 2004-11-05 |
| T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 (K040684) | Spectros Corporation | 2004-11-05 |
| MININEPH HUMAN RHEUMATOID FACTOR KIT (K041891) | The Binding Site | 2004-11-05 |
| LIQUICHEK RETICULOCYTE CONTROL (A) (K042836) | Bio-Rad | 2004-11-05 |
| TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR (K042652) | Taiwan King Strong Co., Ltd. | 2004-11-04 |
| C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM (K042798) | Interpore Cross Intl. | 2004-11-04 |
| MSD SILO SPINAL SYSTEM (K042210) | Medtronic Sofamor Danek | 2004-11-04 |
| METAL/METAL HIP SYSTEM (K040354) | Encore Medical L.P. | 2004-11-04 |
| ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING (K042337) | Zimmer, Inc. | 2004-11-04 |
| NEO-CLIP ORTHODONTIC BRACKET ACCESSORY (K042905) | Dentsply Intl. | 2004-11-04 |
| ARTHREX TRIMIT FAMILY (K041189) | Arthrex, Inc. | 2004-11-04 |
| VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX (K042776) | Zimmer, Inc. | 2004-11-04 |
| BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE (K042778) | Linvatec Corp. | 2004-11-04 |
| ARTHREX TENODESIS SCREW FAMILY (K041356) | Arthrex, Inc. | 2004-11-04 |
| INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER (K042775) | Irvine Biomedical, Inc. | 2004-11-04 |
| CD HORIZON SPINAL SYSTEM (K042790) | Medtronic Sofamor Danek | 2004-11-04 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K042120) | Shijiazhuang Manful Light Industrial Products Co., | 2004-11-04 |
| HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) (DEN040009) | Hamilton Thorne Biosciences | 2004-11-04 |
| GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL (K042844) | Ge Medical Systems, Inc. | 2004-11-03 |
| POWDER-FREE VINYL PATIENT EXAMINTION GLOVES (K042119) | Shijiazhuang Manful Light Industrial Products Co., | 2004-11-03 |
| BEST BREAST BRACHYTHERAPY APPLICATOR (K042586) | Best Medical International, Inc. | 2004-11-03 |
| AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) (K042642) | Ge Medical Systems Information Technologies | 2004-11-03 |
| ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) (K042307) | Seradyn, Inc. | 2004-11-03 |
| HI-ART SYSTEM (K042739) | Tomotherapy Incorporated | 2004-11-03 |
| TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR (K042350) | Cadwell Laboratories, Inc. | 2004-11-03 |
| I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM (K042948) | Wandong Medical | 2004-11-03 |
| 'RAPIDTEC 4' TEST (K041712) | American Bio Medica Corp. | 2004-11-03 |
| GENICON BIPOLAR FORCEPS MODEL # 600-005-005 (K041968) | Genicon | 2004-11-03 |
| AQUIFY LENS COMFORT DROPS (K042176) | Ciba Vision Corporation | 2004-11-03 |
| RANDOX OPIATES ASSAY (K041144) | Randox Laboratories, Ltd. | 2004-11-03 |
| MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 (K042434) | NOUVAG AG | 2004-11-03 |
| JETSTREAM WORKSPACE (K042880) | Adac Laboratories | 2004-11-03 |
| NEOPLANT IMPLANT SYSTEM (K042339) | Neobiotech Co., Ltd. | 2004-11-02 |
| ADEPT ULTRALITE 532 LASER (K042496) | Adept Medical Concepts | 2004-11-02 |
| LIQUICHEK ELEVATED CRP CONTROL (K042837) | Bio-Rad | 2004-11-02 |
| AMX5 AND AMX5D MOBILE X-RAY SYSTEMS (K042866) | Ge Healthcare Technologies | 2004-11-02 |
| QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS (K042446) | Bio-Rad Laboratories, Inc. | 2004-11-02 |
| SHUNTCHECK (PROMETHEUS 1) (K040021) | Samuel Neff M.D. | 2004-11-02 |
| PHILIPS ORTHOPAEDIC APPLICATIONS (K042867) | Philips Medical Systems North America, Inc. | 2004-11-02 |
| 3M TEGADERM SILVER (K040890) | 3M Company | 2004-11-02 |
| CUFFPATCH (K042809) | Organogenesis, Inc. | 2004-11-02 |
| INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM (K042069) | Acmi Corporation | 2004-11-01 |
| VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS (K042093) | Biomet, Inc. | 2004-11-01 |
| VERSATILE 1 WOUND VACUUM SYSTEM (K042134) | Blue Sky Medical Group Incorporated | 2004-11-01 |
| GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A (K040301) | Gambro Renal Products | 2004-11-01 |
| FUTURABOND NR (K042670) | Voco GmbH | 2004-11-01 |
| SAVEDENT BLUE (K042196) | Denfotex Light Systems, Ltd. | 2004-11-01 |
| TRIFUSION, MODEL 0609190/0659350 (K041088) | C.R. Bard, Inc. | 2004-11-01 |
| TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) (K042485) | Roche Diagnostics Corp. | 2004-10-29 |
| MENTOR GENESIS PENILE PROSTHESIS (K040959) | Mentor Corp. | 2004-10-29 |
| IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING (K041490) | B.Braun Medical, Inc. | 2004-10-29 |
| ON-BOARD IMAGER DEVICE (K042720) | Varian Medical Systems | 2004-10-29 |
| HDL-EX SEIKEN ASSAY KIT (K041090) | Denka Seiken Co., Ltd. | 2004-10-29 |
| INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS (K042480) | Hologic, Inc. | 2004-10-29 |
| NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS (K041100) | Zimmer, Inc. | 2004-10-29 |
| NCB PLATING SYSTEM (K042695) | Zimmer GmbH | 2004-10-29 |
| C-PET PLUS IMAGING SYSTEM (K042839) | Philips Medical Systems (Cleveland), Inc. | 2004-10-29 |
| QC-BEADS (K042750) | Bioscreen, Inc. | 2004-10-29 |
| DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT (K042193) | Diazyme Laboratories | 2004-10-29 |
| TI - SCREW ANCHOR SP (K042460) | Arthrotek, Inc. | 2004-10-29 |
| PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES (K042598) | Zimmer, Inc. | 2004-10-29 |
| MAMMOTEST (K042095) | Fischer Imaging Corp. | 2004-10-29 |
| DIAZYME POTASSIUM ENZYMATIC ASSAY KIT (K042191) | Diazyme Laboratories | 2004-10-29 |
| MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER (K042724) | Beckman Coulter, Inc. | 2004-10-29 |
| DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT (K042448) | General Atomics | 2004-10-29 |
| ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) (K042793) | Siemens Medi Cal Solutions, Inc. | 2004-10-29 |
| AUTOSPECS (K042903) | Adac Laboratories | 2004-10-29 |
| CENTURION SES EPIKERATOME (K042810) | Norwood Abbey , Ltd. | 2004-10-28 |