| LED TURBO-PEN (K041303) | Apoza Enterprise Co., Ltd. | 2004-06-18 |
| PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE (K033785) | Discus Dental, Inc. | 2004-06-18 |
| ALADYN RIGID SPINE PLATE (K040747) | Scient'X | 2004-06-17 |
| THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F (K023956) | Mesure Technology Co., Ltd. | 2004-06-17 |
| EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE (K040755) | Exactech, Inc. | 2004-06-17 |
| CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM (K040864) | Aesculap | 2004-06-17 |
| MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR (K040847) | Draeger Medical, Inc. | 2004-06-17 |
| THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000 (K041200) | Migun Medical Instrument Co. , Ltd. | 2004-06-17 |
| QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT (K041487) | Usa Instruments, Inc. | 2004-06-17 |
| INTEGRA BONE FIXATION SYSTEM (K040860) | Integra LifeSciences Corporation | 2004-06-17 |
| BBP BONE SUBSTITUTES (K030195) | Oct, USA, Inc. | 2004-06-17 |
| FSH MENOPAUSE PREDICTOR TEST (K041165) | ACON Laboratories, Inc. | 2004-06-17 |
| MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) (K041229) | Cosmedent, Inc. | 2004-06-17 |
| HSG CATHETER SET (K041094) | Bioteque America, Inc. | 2004-06-17 |
| CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS (K041542) | Neusoft Digital Medical Systems Co., Ltd. | 2004-06-17 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS (K041322) | Ortho-Clinical Diagnostics, Inc. | 2004-06-17 |
| GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM (K041476) | Ge Medical Systems, LLC | 2004-06-17 |
| NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS (K040310) | National Display Systems | 2004-06-17 |
| MODULAR REPLACEMENT SYSTEM CEMENTED STEMS (K040749) | Howmedica Osteonics Corp. | 2004-06-17 |
| MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE (K040837) | Medicel AG | 2004-06-17 |
| NEUROQ - PET DP (K041022) | Syntermed, Inc. | 2004-06-17 |
| ASSURE ANTERIOR CERVICAL PLATE SYSTEM (K040721) | Globus Medical, Inc. | 2004-06-17 |
| AEQUALIS SHOULDER SYSTEM (K041339) | Tornier | 2004-06-17 |
| SKY BONE EXPANDER SYSTEM (SKY SYSTEM) (K040612) | Disc-O-Tech Medical Technologies, Ltd. | 2004-06-17 |
| BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 (K040030) | Biocheck, Inc. | 2004-06-16 |
| DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES (K040967) | Zi BO Hong Wang Plastic & Rubber Products Co. , Ltd. | 2004-06-16 |
| HEXAPOD RT COUCHTOP (K041448) | Medical Intelligence Medizintechnik GmbH | 2004-06-16 |
| XENO NM LIGHT CURED DENTAL ADHESIVE (K041343) | Dentsply International | 2004-06-16 |
| PTM SYSTEM (K041335) | Dentsply International | 2004-06-16 |
| RANDOX IMMUNOASSAY CONTROL (K040379) | Randox Laboratories, Ltd. | 2004-06-16 |
| CALIBRA CEMENT (K040906) | Dentsply Intl. | 2004-06-16 |
| ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM (K041158) | Atrion Medical Products, Inc. | 2004-06-16 |
| POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER (K040332) | Arkray, Inc. | 2004-06-16 |
| DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P (K033896) | Defibtech, LLC | 2004-06-16 |
| MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS (K041402) | Implant Innovations, Inc. | 2004-06-16 |
| VARELISA MPO ANCA, MODEL 17648/17696 (K041040) | Sweden Diagnostics (Germany) GmbH | 2004-06-16 |
| DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 (K041141) | Dentsply Intl. | 2004-06-16 |
| DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I (K040443) | Dome Imaging Systems, Inc. | 2004-06-16 |
| RELIANT LASER SYSTEM II (K040617) | Reliant Technologies, Inc. | 2004-06-15 |
| PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16 (K040835) | Pm Devices, Inc. | 2004-06-15 |
| DIGORA OPTIME (OR DIGORA ONTIME) (K041050) | Soredex Palodex Group OY | 2004-06-15 |
| STAY-PUT IMPREGNATED (K041023) | Coltene/Whaledent GmbH & Co. KG | 2004-06-15 |
| BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER (K041331) | Biopsy Sciences, LLC | 2004-06-15 |
| SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS (K040701) | Synthes (Usa) | 2004-06-15 |
| LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS (K030831) | Modern Medical Equipment Mfg., Ltd. | 2004-06-15 |
| MEDTRONIC PS MEDICAL STRATA VALVE (K040943) | Medtronic Neurosurgery | 2004-06-15 |
| MODERN MEDICAL BIPOLAR FORCEPS (K032327) | Modern Medical Equipment Mfg., Ltd. | 2004-06-15 |
| OLINDA/EXM (K033960) | Vanderbilt University | 2004-06-15 |
| GE DISCOVERY ST SYSTEM (K041220) | GE Medical Systems | 2004-06-15 |
| S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K040900) | Optical Connection, Inc. | 2004-06-15 |
| MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM (K041307) | Stryker Endoscopy | 2004-06-14 |
| CONTOUR HA COATED RECONSTRUCTION RING (K040680) | Smith & Nephew, Inc. | 2004-06-14 |
| HILUX LEDMAX 3 (K040956) | First Medical Infection Control Associates, Inc. | 2004-06-14 |
| STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230 (K041383) | Stellartech Research Corp. | 2004-06-14 |
| STRYKER WEDGE SUTURE ANCHOR SYSTEM (K041310) | Stryker Endoscopy | 2004-06-14 |
| STRYKER BIOZIP SUTURE ANCHOR SYSTEM (K041305) | Stryker Endoscopy | 2004-06-14 |
| QUEST DIAGNOSTICS HAIRCHECK-DT (THC) (K040257) | Quest Diagnostics, Inc. | 2004-06-14 |
| ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS (K040425) | Bayer Healthcare, LLC | 2004-06-14 |
| MODIFICATION TO TSRH SPINAL SYSTEM (K041282) | Medtronic Sofamor Danek, Inc. | 2004-06-10 |
| 21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A) (K040697) | Totoku Electric Co., Ltd. | 2004-06-10 |
| HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT (K033477) | Rochester Medical Corp. | 2004-06-10 |
| CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY (K041315) | Accuray, Inc. | 2004-06-10 |
| AXIOM ARTIS U (K040675) | Siemens Medical Systems, Inc. | 2004-06-10 |
| RE-USEABLE MICROSTAAR INJECTOR, MSI-S (K032412) | Staar Surgical Co. | 2004-06-10 |
| INCUBATOR CAPE (K040794) | Wrapped IN Comfort | 2004-06-10 |
| SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K041455) | Sonoscape Company Limited | 2004-06-10 |
| ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 (K040926) | Hudson Diagnostic Imaging, LLC | 2004-06-10 |
| JAX-TCP (K033552) | Smith & Nephew, Inc. | 2004-06-10 |
| DISPOSABLE OVERTUBE (K040836) | United States Endoscopy Group, Inc. | 2004-06-10 |
| BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 (K040657) | Vygon SA | 2004-06-10 |
| MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI (K041296) | Codman & Shurtleff, Inc. | 2004-06-10 |
| HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM (K041234) | Hemocue, Inc. | 2004-06-10 |
| MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) (K040723) | Microlife Intellectual Property GmbH | 2004-06-10 |
| R-TEST EVOLUTION 3 (K040753) | Novacor | 2004-06-10 |
| VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 (K040882) | bioMerieux, Inc. | 2004-06-10 |
| NUMED PTS X SIZING BALLOON CATHETER (K041306) | NuMED, Inc. | 2004-06-10 |
| SSA-770A, APLIO VERSION 5.5 (K041499) | Toshibamedical Systems Corporation | 2004-06-10 |
| CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) (K040941) | Fisher & Paykel Healthcare, Ltd. | 2004-06-10 |
| MODIFICATION TO SMARTPIN (K041288) | Linvatec Biomaterials, Inc. | 2004-06-10 |
| AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER (K041418) | Cardinalhealth | 2004-06-10 |
| EYE SPHERE IMPLANTS (K040689) | Oculo Plastik, Inc. | 2004-06-10 |
| CDS HEMATOLOGY CALIBRATOR (CDS CAL) (K041130) | Clinical Diagnostic Solutions, Inc. | 2004-06-10 |
| RANDOX AMIKACIN (K033884) | Randox Laboratories, Ltd. | 2004-06-09 |
| MEDICAL AIR COMPRESSOR (K040220) | eVent Medical, Ltd. | 2004-06-09 |
| MIS DENTAL IMPLANT SYSTEM (K040807) | Mis - Implant Technologies , Ltd. | 2004-06-09 |
| RADENT PROPHY PASTE (K040661) | Pascal Co., Inc. | 2004-06-09 |
| HOUVA 3 PHOTOTHERAPY SYSTEM (K041212) | National Biological Corp. | 2004-06-09 |
| EG-3830UT (K041397) | Pentax Precision Instrument Corp. | 2004-06-09 |
| EG-3630UR (K041395) | Pentax Precision Instrument Corp. | 2004-06-09 |
| HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND (K041035) | Hoffrichter GmbH | 2004-06-09 |
| AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 (K041156) | Nonin Medical, Inc. | 2004-06-09 |
| FG-36UX FIBER ULTRASOUND GASTROSCOPE (K041396) | Pentax Precision Instrument Corp. | 2004-06-09 |
| MAXO2+, MODEL A AND AE (K040484) | Maxtec, Inc. | 2004-06-09 |
| BIO-RAD D-10 DUAL PROGRAM (K041444) | Bio-Rad Laboratories, Inc. | 2004-06-09 |
| CLEARBLUE EASY EASY READ PREGNANCY TEST (K041404) | Unipath , Ltd. | 2004-06-08 |
| VITEK 2 ESBL TEST (K040845) | bioMerieux, Inc. | 2004-06-08 |
| CONTROL SOLUTIONS, INC., MODEL CS3102 HVG (K041146) | Control Solutions, Inc. | 2004-06-08 |
| IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR (K041380) | R2 Technology, Inc. | 2004-06-08 |
| MRA-CMS (K040746) | Medis Medical Imaging Systems BV | 2004-06-08 |
| MICRODERM, MODEL/VERSION 3.5 (K040171) | Visiomed AG | 2004-06-08 |