| PLANMED SOPHIE NUANCE CLASSIC (K042671) | Planmed OY | 2004-11-19 |
| NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K042661) | Barco NV Barcoview | 2004-11-19 |
| SELF RETAINING BICANALICULUS INTUBATION SET (K041869) | Fci Ophthalmics, Inc. | 2004-11-18 |
| METRICATH SYSTEM (K042685) | Angiometrx, Inc. | 2004-11-18 |
| SDS-4I (K034005) | Skylark Device & Systems Co., Ltd. | 2004-11-18 |
| BEST MODEL # 81-01 SERIES IR-192 SOURCES (K042786) | Best Medical International, Inc. | 2004-11-18 |
| PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 (K043042) | Nobel Biocare AB | 2004-11-18 |
| FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 (K042076) | Fujinon, Inc. | 2004-11-18 |
| VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS (K042521) | Ortho-Clinical Diagnostics, Inc. | 2004-11-18 |
| CD HORIZON SPINAL SYSTEM (K042886) | Medtronic Sofamor Danek | 2004-11-18 |
| QUIKREAD CRP CALIBRATOR SET (K042625) | Orion Diagnostica, OY | 2004-11-18 |
| SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM (K042365) | Synthes (Usa) | 2004-11-18 |
| URS LP DIGITAL, MILLENNIUM, RADPRO (K042876) | Sedecal., Sa. | 2004-11-18 |
| GRADIA DIRECT LOFLO (K042348) | GC America, Inc. | 2004-11-18 |
| ADVANCED LUNG ANALYSIS II (K042694) | GE Medical Systems | 2004-11-18 |
| VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II (K042643) | Ortho-Clinical Diagnostics, Inc. | 2004-11-18 |
| SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR (K043002) | Sedecal., Sa. | 2004-11-18 |
| IOP8 INTRA OPERATIVE PROBE (K032315) | Huntleigh Healthcare, Inc. | 2004-11-18 |
| PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A (K043111) | Toshiba America Medical Systems, In.C | 2004-11-18 |
| BASBA E-MACHINE (K041172) | Basba, Inc. | 2004-11-18 |
| PMD-2000 INTERFERENTIAL STIMULATOR (K042881) | Phoenix Medical Devices, LLC | 2004-11-18 |
| MINIMESH POLYPROPYLENE MESH (K041632) | Mpathy Medical Devices, Ltd. | 2004-11-17 |
| PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA (K041323) | New Star Lasers, Inc. | 2004-11-17 |
| WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES (K042761) | Zimmer, Inc. | 2004-11-17 |
| SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL (K042359) | Medical Designs, LLC | 2004-11-17 |
| GEM-TWIN TENS/ MODELS GM3XY/Z (K042559) | Gemore Technology Co, Ltd. | 2004-11-17 |
| HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE (K042980) | Hospira, Inc. | 2004-11-17 |
| IVENT 201 PORTABLE VENTILATOR (K042468) | Versamed Medical Systems, Inc. | 2004-11-17 |
| OMNIPULSE MINI, MODEL 2120 (K043012) | Trimedyne, Inc. | 2004-11-17 |
| OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 (K041983) | Opticon Medical | 2004-11-17 |
| IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE (K042256) | Usa Laser Biotech, Inc. | 2004-11-17 |
| FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 (K042039) | Cleveland Medical Devices, Inc. | 2004-11-17 |
| NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A (K043078) | Toshiba America Medical Systems, In.C | 2004-11-17 |
| MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM (K042986) | Synthes (Usa) | 2004-11-17 |
| TIDI BRAND STERILIZATION WRAP (K042580) | Banta Healthcare Group, Ltd. | 2004-11-17 |
| SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM (K043008) | Surgrx, Inc. | 2004-11-17 |
| POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES (K042830) | Grand Work Plastic Products Co., Ltd. | 2004-11-17 |
| ALUMINA HEAD (K042035) | Fournitures Hospitalieres Industrie | 2004-11-17 |
| SMOKE EVACUATION ATTACHEMENT (K033095) | Modern Medical Equipment Mfg., Ltd. | 2004-11-17 |
| SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT (K042459) | Beckman Coulter, Inc. | 2004-11-17 |
| MULTI-CHEM CALIBRATOR A (K042551) | Wako Chemicals USA, Inc. | 2004-11-16 |
| FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS (K042824) | CooperVision, Inc. | 2004-11-16 |
| OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (K041443) | Osteoimplant Technology, Inc. | 2004-11-16 |
| MICROVERTER URETERAL ACCESS SHEATH (K042877) | Percutaneous Systems, Inc. | 2004-11-16 |
| HYDROGEL CANALICULAR PLUG (K040912) | Partners IN Biomaterials, Inc. | 2004-11-16 |
| DYNAMOMETER - MODEL FCE AND MODEL MSC (K042889) | Ametek | 2004-11-16 |
| ORTHOFIX VOLAR DISTAL RADIAL PLATE (K042766) | Orthofix, Inc. | 2004-11-16 |
| SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES (K042895) | Synthes (Usa) | 2004-11-16 |
| SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM (K043016) | Siemens Medical Solutions USA, Inc. | 2004-11-16 |
| RESTITU (K041937) | Resonant Medical, Inc. | 2004-11-16 |
| MODIFICATION TO VISITOME 20-10 MICROKERATOME (K042083) | Biovision AG | 2004-11-16 |
| STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM (K042733) | Standard Imaging, Inc. | 2004-11-15 |
| AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR (K042682) | Ambu, Inc. | 2004-11-15 |
| XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (K041951) | Remel, Inc. | 2004-11-15 |
| THE 5.0 X 6.0MM DENTAL IMPLANT (K042637) | Bicon, Inc. | 2004-11-15 |
| MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (K041852) | Minrad, Inc. | 2004-11-15 |
| STERICHEK GLUTARALDEHYDE REAGENT STRIPS (K040660) | Hach Company | 2004-11-15 |
| BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION (K042197) | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004-11-15 |
| D3 CHROMA (K042422) | Sybron Dental Specialties, Inc. | 2004-11-15 |
| MILLENIUM, MODELS 2000, 2001 AND 2002 (K041007) | Hyperbaric For Life, LLC | 2004-11-15 |
| ASCENSION PYROSPHERE (PCS) (K042690) | Ascension Orthopedics, Inc. | 2004-11-13 |
| THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS (K042845) | Philips Medizin Systeme Boblingen GmbH | 2004-11-12 |
| OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE (K042914) | Opus Medical, Inc. | 2004-11-12 |
| NICOM (K042144) | Cheetah Medical, Inc. | 2004-11-12 |
| AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS (K042843) | Ambu, Inc. | 2004-11-12 |
| RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM (K042908) | Guidant Corp. | 2004-11-12 |
| GENEMAX POWER WHEELCHAIR, PW3 (K042748) | Genemax Medical Products Industry Corp. | 2004-11-12 |
| SENSATOUCH (K042250) | Aluna Management Co., Ltd. | 2004-11-12 |
| UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS (K042291) | Beckman Coulter, Inc. | 2004-11-12 |
| GENICON SUCTION IRRIGATION SYSTEM (K041967) | Genicon | 2004-11-12 |
| COOL-TIP RF ABLATION SYSTEM (K042216) | Valleylab | 2004-11-12 |
| INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT (K042855) | Intuitive Surgical, Inc. | 2004-11-12 |
| STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A (K042909) | Stellartech Research Corp. | 2004-11-12 |
| TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 (K041595) | Biopro, Inc. | 2004-11-12 |
| LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE (K042611) | Cook, Inc. | 2004-11-12 |
| GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES (K042231) | Biocompatibles UK Limited | 2004-11-12 |
| GENEMAX POWER WHEELCHAIR, PW4 (K042749) | Genemax Medical Products Industry Corp. | 2004-11-12 |
| 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA (K042718) | Siemens Medi Cal Solutions, Inc. | 2004-11-12 |
| FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 (K041903) | Fujinon, Inc. | 2004-11-10 |
| VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM (K042188) | Volcano Therapeutics, Inc. | 2004-11-10 |
| ORAJEL ADVANCED TOOTH DESENSITIZER (K041680) | Del Pharmaceuticals, Inc. | 2004-11-10 |
| AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 (K042171) | Micro-Mega Societe Anonyme | 2004-11-10 |
| ACCUPACH V (K042752) | Accutome Ultrasound, Inc. | 2004-11-10 |
| OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 (K043018) | Omron Healthcare, Inc. | 2004-11-10 |
| PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S (K041855) | Aearo Co. | 2004-11-10 |
| DEMETRON IDS CURING LIGHT (K042888) | Kerr Corp. | 2004-11-10 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA (K042853) | Health & Life Co., Ltd. | 2004-11-10 |
| SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 (K041818) | Boston Scientific Corp | 2004-11-10 |
| VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC (K042475) | Ortho-Clinical Diagnostics, Inc. | 2004-11-10 |
| TRAUMACAD 1.2 (K042816) | Orthocrat, Ltd. | 2004-11-10 |
| ENTERYX INJECTION CATHETER (K042882) | Boston Scientific Corp | 2004-11-09 |
| FASTIN RC ANCHOR (K041075) | Depuy Mitek, A Johnson & Johnson Company | 2004-11-09 |
| MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT (K042851) | Mentor Corp. | 2004-11-09 |
| GEMINI GXL (K042935) | Philips Medical Systems (Cleveland), Inc. | 2004-11-09 |
| PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) (K042949) | C.R. Bard, Inc. | 2004-11-09 |
| TETRIC EVOCERAM (K042819) | Ivoclar Vivadent, Inc. | 2004-11-09 |
| SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS (K041170) | Howmedica Osteonics Corp. | 2004-11-09 |
| SPIRALOK ANCHOR (K041069) | Depuy Mitek, A Johnson & Johnson Company | 2004-11-09 |
| NOVATION 12/14 PRESS-FIT FEMORAL STEM (K042842) | Exactech, Inc. | 2004-11-09 |
| X-SERIES INTEGRAL RPP FEMORAL COMPONENTS (K042029) | Biomet, Inc. | 2004-11-09 |