| BAHA DIVINO (K042017) | Entific Medical Systems, Inc. | 2004-08-26 |
| RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 (K041123) | Kerberos Proximal Solutions, Inc. | 2004-08-26 |
| STORZ MODULITH, MODEL SLX-F2 (K040476) | KARL STORZ Endoscopy-America, Inc. | 2004-08-26 |
| AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR (K040580) | D.Y. Instrument, Inc. | 2004-08-26 |
| NAME BONE VOID FILLER (K041421) | Stryker Biotech | 2004-08-26 |
| TIDAL WAVE SP MODEL 710/715 AND 715 (K032971) | Respironics Novametrix, Inc. | 2004-08-26 |
| SABRESOURCE DRAPE (K041846) | Minrad, Inc. | 2004-08-26 |
| NOBEL BIOCARE ENDOSSEOUS IMPLANTS (K041661) | Nobel Biocare Uas, Inc. | 2004-08-26 |
| 11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL (K042207) | Usa Instruments, Inc. | 2004-08-26 |
| OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION (K041931) | Ge Oec Medical Systems, Inc. | 2004-08-26 |
| 3.0T 8-CHANNEL CTL SPINE ARRAY (K042186) | Usa Instruments, Inc. | 2004-08-26 |
| URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS (K040703) | Dirui Industrial Co., Ltd. | 2004-08-26 |
| FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER (K042023) | Fujifilm Medical System U.S.A., Inc. | 2004-08-25 |
| BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID (K041616) | Orthos (Uk) Limited | 2004-08-25 |
| VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS (K041799) | Ortho-Clinical Diagnostics, Inc. | 2004-08-25 |
| NANMA VACUUM PUMP PROXZEK MODEL 2M9498S (K041573) | Nanma Mfg Co., Ltd. | 2004-08-25 |
| NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE (K041613) | Novabone Products, LLC | 2004-08-25 |
| ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 (K041451) | Ascension Orthopedics, Inc. | 2004-08-25 |
| 5000Z SYSTEM (OTC) (K033122) | Prizm Medical, Inc. | 2004-08-25 |
| AEQUALIS REVERSED SHOULDER PROSTHESIS (K041873) | Tornier | 2004-08-25 |
| VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II (K041720) | Ortho-Clinical Diagnostics, Inc. | 2004-08-25 |
| BICONTACT HIP STEM AND FEMORAL HEAD (K040191) | Aesculap | 2004-08-25 |
| SNAP-OFF SCREWS (K041456) | Fournitures Hospitalieres Industrie | 2004-08-25 |
| KLSA MARTIN HAND DISTRACTOR (K042066) | KLS-Martin L.P. | 2004-08-25 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K042025) | Medtronic Sofamor Danek, Inc. | 2004-08-25 |
| MODIFICATION TO RESTORATION MODULAR SYSTEM (K040734) | Howmedica Osteonics Corp. | 2004-08-25 |
| PIESOMETER, MODEL MK-1 (K041169) | Canamet Canadian Natl Medical Technologies, Inc. | 2004-08-24 |
| NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 (DEN040002) | Perkinelmer Life Sciences, Inc. | 2004-08-24 |
| NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4 (K041845) | Nexus Medical, LLC | 2004-08-24 |
| FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 (K042138) | Sein Electronics Co., Ltd. | 2004-08-24 |
| MONITORING SYSTEM, MODEL ARGUS PB-2200 (K033738) | Schiller AG | 2004-08-24 |
| PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K042081) | Hospira, Inc. | 2004-08-24 |
| FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 (K041400) | Fortifier International Co., Ltd. | 2004-08-24 |
| MARE DENTAL OPERATIVE UNIT (K041458) | Denimed Electronica S.H. | 2004-08-24 |
| TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM (K032291) | Linde Medical Sensors AG | 2004-08-24 |
| MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (K041974) | Med2000 S.R.L. | 2004-08-24 |
| PENCIL POINT NEEDLE (K041843) | Epimed International, Inc. | 2004-08-24 |
| SMITH & NEPHEW GRAFT DELIVERY SYSTEM (K041976) | Smith & Nephew, Inc. | 2004-08-23 |
| MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT (K042204) | Ev3, Inc. | 2004-08-23 |
| AIRGUARD VALVED INTRODUCER (K042036) | C.R. Bard, Inc. | 2004-08-23 |
| SPOT CHECK PULSE OXIMETER,512/513 (K032949) | Respironics Novametrix, Inc. | 2004-08-23 |
| VECTORVISION HIP 3.0 (K040368) | Brainlab AG | 2004-08-23 |
| BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN (K041371) | Novamin Technology, Inc. | 2004-08-23 |
| POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR (K041848) | Pt. Smartglove Indonesia | 2004-08-20 |
| BODY CLOCK STIMPLUS AND STIMPLUS PRO (K041359) | Body Clock Health Care, Ltd. | 2004-08-20 |
| RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM (K040996) | Gyrus Ent LLC | 2004-08-20 |
| OSSATURA DENTAL (K031813) | Isotis NV | 2004-08-20 |
| SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 (K041436) | Terang Nusa Sdn Bhd | 2004-08-20 |
| POWDER-FREE NITRILE EXAMINATION GLOVES (K041276) | Shanghai Motex Healthcare Co., Ltd. | 2004-08-20 |
| MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799 (K041409) | Inomed GmbH | 2004-08-20 |
| IMMUNOCARD TOXINS A & B, MODEL 712050 (K041003) | Meridian Bioscience, Inc. | 2004-08-20 |
| POWDER-FREE BLUE VINYL EXAM GLOVES (K041945) | Glormed Intl., Inc. | 2004-08-20 |
| MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM (K041840) | Medx, Inc. | 2004-08-20 |
| NOBELDIRECT OD IMPLANT (K041876) | Nobel Biocare Uas, Inc. | 2004-08-20 |
| GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 (K041981) | Guidant Corporation | 2004-08-20 |
| TRI-OSTETIC (K041889) | Berkeley Advanced Biomaterials, Inc. | 2004-08-19 |
| TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM (K042080) | Home Diagnostics, Inc. | 2004-08-19 |
| BRIGHT GOLD XH (K041433) | Ivoclar Vivadent, Inc. | 2004-08-19 |
| SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS (K041887) | Synthes (Usa) | 2004-08-19 |
| OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT (K041668) | Olympus America, Inc. | 2004-08-19 |
| CEMENTEK (K041493) | Teknimed, S.A. | 2004-08-19 |
| SENORX INTRODUCER (K042098) | Senorx, Inc. | 2004-08-19 |
| AARHUS ANCHORAGE SYSTEM (K041527) | Medicon EG | 2004-08-19 |
| SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW (K040542) | Smith & Nephew, Inc. | 2004-08-19 |
| ULTRASOUND LOCALIZATION SYSTEM ULS 0142 (K040741) | Hmt High Medical Technologies AG | 2004-08-19 |
| MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY (K041995) | Uresil, LLC | 2004-08-19 |
| COCOON HYGIENIST (K040529) | Satelec | 2004-08-19 |
| MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 (K041610) | Richard Wolf Medical Instruments Corp. | 2004-08-19 |
| OLYMPUS BF TYPE UC160-OL8 (K042140) | Olympus Corporation | 2004-08-18 |
| WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE (K040490) | Welch Allyn, Inc. | 2004-08-18 |
| VENTURE WIRE CONTROL CATHETER (K040922) | Velocimed, Inc. | 2004-08-18 |
| HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS (K040799) | Hommed, LLC | 2004-08-18 |
| SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT (K041643) | Beckman Coulter, Inc. | 2004-08-18 |
| OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM (K041932) | Ge Oec Medical Systems, Inc. | 2004-08-18 |
| ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR (K041687) | Abbott Laboratories | 2004-08-18 |
| MICROSELECTRON PDR (K041933) | Nucletron Corp. | 2004-08-18 |
| FASSIER-DUVAL TELSCOPIC IM SYSTEM (K041393) | Pega Medical, Inc. | 2004-08-17 |
| PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) (K031152) | Propper Mfg. Co., Inc. | 2004-08-17 |
| EXPEDIUM ANTERIOR SPINE SYSTEM (K041205) | Depuy Spine, Inc. | 2004-08-17 |
| DC-ACETA/SAL CONTROLS (K041666) | Diagnostic Chemicals , Ltd. | 2004-08-17 |
| BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS (K041939) | Blackstone Medical, Inc. | 2004-08-17 |
| SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 (K040525) | Sontra Medical, Inc. | 2004-08-17 |
| OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN (K040108) | Est International Corporation | 2004-08-17 |
| INION TRINION BIODEGRADABLE MENISCUS SCREW (K031714) | Inion , Ltd. | 2004-08-16 |
| MICRO PRIME (K041650) | Innovx Medical, Inc. | 2004-08-16 |
| EBI LACTOSORB GRAFT CONTAINMENT SYSTEM (K033918) | Ebi, L.P. | 2004-08-16 |
| NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL (K042103) | Mri Devices Corporation | 2004-08-16 |
| DR SYSTEMS PACS, RELEASE 6.1 (K041935) | Dr Systems, Inc. | 2004-08-16 |
| SILVER FOAM WOUND DRESSING (K032742) | Advanced Medical Solutions, Ltd. | 2004-08-16 |
| MACRO-MICRO DEPTH ELECTRODE (K041604) | Ad-Tech Medical Instrument Corp | 2004-08-16 |
| PHACO CHOP NEEDLES (K041998) | Bausch & Lomb, Inc. | 2004-08-16 |
| SEEMOR 5.0 IMAGE DISPLAY PROGRAM (K041782) | Areeda Assoc., Ltd. | 2004-08-16 |
| POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX (K033707) | Osteobiologics, Inc. | 2004-08-16 |
| I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND (K041947) | Innovative Imaging, Inc. | 2004-08-16 |
| NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM (K041447) | Nuvasive, Inc. | 2004-08-16 |
| TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 (K040819) | American I.V. Products, Inc. | 2004-08-16 |
| N LATEX CYSTATIN (K041878) | Dade Behring, Inc. | 2004-08-16 |
| INTERLAB MICROCAL SERUM CONTROLS (K041871) | Trouble Shooter Consuling, Inc. | 2004-08-16 |
| KMI DISTAL VOLAR RADIUS PLATE SYSTEM (K041461) | Kinetikos Medical, Inc. | 2004-08-16 |
| MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K041973) | Intra Luminal Therapeutics, Inc. | 2004-08-16 |