| NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 (K040813) | Nichols Institute Diagnostics | 2004-06-08 |
| IPACS ORTHO (K041366) | Realtimeimage, Inc. | 2004-06-08 |
| NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K041041) | Shanghai Foremost Plastic Industrial Co., Ltd. | 2004-06-08 |
| POISE DATAENGINE (K040969) | Poise Technology Corporation | 2004-06-08 |
| FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM (K040048) | Fujinon, Inc. | 2004-06-07 |
| IRRIGATION TUBING SET 2.2M AND 3.8M (K041124) | W&H Dentalwerk Burmoos | 2004-06-07 |
| SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM (K041319) | Siemens Medical Solutions USA, Inc. | 2004-06-07 |
| QUANTIX OR VESSEL STABILIZER DEVICE (K041180) | Cardiosonix, Ltd. | 2004-06-07 |
| ECAT HRRT (K040933) | Cti Pet Systems, Inc. | 2004-06-07 |
| PASCO MIC AND MIC/ID PANELS (K041214) | Pasco Laboratories, Inc. | 2004-06-07 |
| VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS (K040333) | Valumax Intl., Inc. | 2004-06-07 |
| SMITH & NEPHEW ULTRABRAID SUTURE (K041216) | Smith & Nephew, Inc. | 2004-06-07 |
| FEMORAL HOOK (K041261) | Arthrotek, Inc. | 2004-06-07 |
| DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES (K041281) | Datascope Corp. | 2004-06-07 |
| MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (K041385) | Schick Technologies, Inc. | 2004-06-07 |
| VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 (K040638) | Vnus Medical Technologies, Inc. | 2004-06-07 |
| 21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A) (K040695) | Totoku Electric Co., Ltd. | 2004-06-07 |
| SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT (K040767) | Beckman Coulter, Inc. | 2004-06-07 |
| VPAP III ST-A (K033276) | Resmed, Ltd. | 2004-06-07 |
| MODIFICATION TO UNITY NETWORK ID (K040559) | Ge Medical Systems Information Technologies | 2004-06-04 |
| SENSILASE PAD 3000 (K040654) | Optical Sensors, Inc. | 2004-06-04 |
| PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10 (K033985) | Pm Devices, Inc. | 2004-06-04 |
| MODULAR RADIAL HEAD REPLACEMENT DEVICE (K040611) | Biomet, Inc. | 2004-06-04 |
| DURABRAID SUTURE (K040789) | Smith & Nephew, Inc. | 2004-06-04 |
| PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS (K041235) | Philips Medizin Systeme Boeblingen GmbH | 2004-06-04 |
| BIODERM SCIENCES WOUND DRESSING (K040683) | Bioderm Sciences, Inc. | 2004-06-04 |
| SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH (K040868) | Genzyme Corp. | 2004-06-04 |
| EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS (K040613) | Exactech, Inc. | 2004-06-04 |
| INVACARE 3G TARSYS (K033819) | Invacare Corp. | 2004-06-04 |
| MODIFICATION TO EN-BLOC BIOPSY SYSTEM (K041347) | Neothermia Corp. | 2004-06-04 |
| POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE (K041048) | Internacional Farmaceutica, S.A. DE C.V. | 2004-06-04 |
| VERSA-DIAL HUMERAL HEAD (K040610) | Biomet Manufacturing, Inc. | 2004-06-04 |
| MODIFICATION TO M2376A DEVICELINK SYSTEM (K041401) | Philips Medical Systems | 2004-06-04 |
| INNERVUE DIAGNOSTIC SCOPE SYSTEM (K040604) | Arthrotek, Inc. | 2004-06-04 |
| LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) (K040699) | Megadyne Medical Products, Inc. | 2004-06-04 |
| MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR (K041179) | Medegen Medical Manufacturing Services, Inc. | 2004-06-04 |
| PSI-TEC PERISTALTIC INFILTRATION PUMP (K040149) | Byron Medical | 2004-06-03 |
| MODIFICATION TO AVANT 9600 PULSE OXIMETER (K040589) | Nonin Medical, Inc. | 2004-06-03 |
| GOLDEN SPYDER, MODEL GS-300 (K041341) | Golden Technologies, Inc. | 2004-06-03 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM (K033711) | Fukuda Denshi USA, Inc. | 2004-06-03 |
| SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM (K040720) | Power Medical Interventions, Inc. | 2004-06-03 |
| BONAMATES SERIES (K040650) | Biotech One, Inc. | 2004-06-03 |
| ULTRACLIP II MR (K041201) | Inrad | 2004-06-03 |
| SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE (K040681) | Grand Work Plastic Products Co., Ltd. | 2004-06-03 |
| LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES (K032767) | Lily Medical Supplies Co., Ltd. | 2004-06-03 |
| RESCONTROL II (K040944) | Resmed, Ltd. | 2004-06-03 |
| MODIFICATION TO DASH 3000/4000 PATIENT MONITOR (K040458) | Ge Medical Systems Information Technologies | 2004-06-03 |
| COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT (K033743) | Cozart Bioscience , Ltd. | 2004-06-03 |
| COSMEDENT CORE PASTE (K040994) | Cosmedent, Inc. | 2004-06-03 |
| MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS (K040790) | Pulmonetic Systems, Inc. | 2004-06-03 |
| VENTLAB NASAL CPAP CANNULA (K040726) | Ventlab Corp. | 2004-06-03 |
| THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES (K033790) | Tecnimed S.R.L. | 2004-06-03 |
| QUICKELISA ANTHRAX-PA KIT (K040407) | Immunetics, Inc. | 2004-06-03 |
| NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 (K040834) | Image-Guided Neurologics, Inc. | 2004-06-03 |
| AIR SAFETY HEPA, MODEL 3500 (K040712) | Air Safety, Ltd. | 2004-06-03 |
| ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN (K040071) | Elite International, Inc. | 2004-06-03 |
| PROCYON SPINAL SYSTEM (K033512) | Nas Medical Technologies, Inc. | 2004-06-03 |
| POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (K040791) | Pt. Smartglove Indonesia | 2004-06-03 |
| AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN (K033489) | Biomet, Inc. | 2004-06-02 |
| SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED (K041240) | Fertility Solutions, Inc. | 2004-06-02 |
| ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM (K040748) | Takara Belmont USA, Inc. | 2004-06-02 |
| TOTAL BILIRUBIN REAGENT SET (K040391) | Pointe Scientific, Inc., | 2004-06-02 |
| COMBOMAP PRESSURE AND FLOW SYSTEM (K041134) | Volcano Therapeutics, Inc. | 2004-06-02 |
| SWIFT ANTERIOR CERVICAL PLATE SYSTEM (K040655) | Depuy Spine, Inc. | 2004-06-02 |
| SUMMIT OCT SPINAL SYSTEM (K041203) | Depuy Spine, Inc. | 2004-06-02 |
| BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY (K033859) | Barco NV Barcoview | 2004-06-02 |
| MODIFICATION TO CAREMATIX WELLNESS SYSTEM (K040966) | Carematix, Inc. | 2004-06-02 |
| LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA (K040642) | Draeget Medical AG & Co. Kgaa | 2004-06-02 |
| SOLARIS D890 THERAPY PROBE (K040729) | Dynatronics Corp. | 2004-06-02 |
| CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS (K033048) | Cas Medical Systems, Inc. | 2004-06-01 |
| MEDI-PUMP ASPIRATOR, MODEL 1615 (K041199) | Thomas Industries | 2004-06-01 |
| EXPORT CATHETER (K040869) | Medtronic Vascular | 2004-06-01 |
| COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM (K040615) | Advanced Vascular Dynamics | 2004-06-01 |
| MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM (K040659) | Mccue Plc | 2004-06-01 |
| CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES (K040395) | Nihon Kohden America, Inc. | 2004-06-01 |
| GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED (K041188) | Grand Work Plastic Products Co., Ltd. | 2004-06-01 |
| NIC36 AMPLIFIER (K041198) | Eb Neuro S.P.A. | 2004-06-01 |
| NUCLEOTOME PROBE SET, MODEL 21200 (K040919) | Clarus Medical, LLC | 2004-06-01 |
| MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM (K040713) | Thomas Medical Products, Inc. | 2004-06-01 |
| SENSITIVE SKIN ANTIBACTERIAL BANDAGES (K032983) | Scivolution, Inc. | 2004-06-01 |
| MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 (K040552) | Cryocor, Inc. | 2004-05-28 |
| PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 (K041117) | Depuy Mitek | 2004-05-28 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K041118) | Medtronic Sofamor Danek | 2004-05-28 |
| MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT (K040758) | Microgenics Corp. | 2004-05-28 |
| LITTLE GRAFTER SCREW (K040265) | Biocomposites, Ltd. | 2004-05-28 |
| HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY (K040293) | Akers Laboratories, Inc. | 2004-05-28 |
| SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS (K040964) | Howmedica Osteonics Corp. | 2004-05-28 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST (K033458) | Becton, Dickinson & CO | 2004-05-28 |
| PRO WALKER ML-300 FOLDABLE WHEELCHAIR (K041337) | Pro Walker, Inc. | 2004-05-28 |
| PROFEMUR TAPERED HIP STEM (K041114) | Wrightmedicaltechnologyinc | 2004-05-28 |
| GII QUICKANCHOR PLUS (K041115) | Depuy Mitek, A Johnson & Johnson Company | 2004-05-28 |
| SUPER QUICKANCHOR PLUS (K041116) | Depuy Mitek | 2004-05-28 |
| KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) (K040891) | KLS-Martin L.P. | 2004-05-28 |
| OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004 (K040664) | Omnilight, Inc. | 2004-05-28 |
| MODIFICATION TO BONE GRAFT WASHER (K041217) | Medtronic Sofamor Danek, Inc. | 2004-05-28 |
| DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 (K040544) | Depuy, Inc. | 2004-05-28 |
| PH BUFFERING PLASTIC APPLICATOR TAMPON (K030474) | Rostam , Ltd. | 2004-05-28 |
| VENOJECT LUER ADAPTER (K041358) | Terumo Europe N.V. | 2004-05-28 |
| KOLPEXIN SPHERE (K032644) | Adamed , Ltd. | 2004-05-28 |
| SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING (K033971) | Howmedica Osteonics Corp. | 2004-05-28 |