| SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM (K032281) | Toshiba America Medical Systems, In.C | 2003-08-06 |
| FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) (K031401) | Disco-O-Tech Medical Technologies, Ltd. | 2003-08-06 |
| SOFT-CELL DUAL LUMEN CATHETERS (K030277) | C.R. Bard, Inc. | 2003-08-06 |
| LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS (K031577) | Cliniqa Corporation | 2003-08-06 |
| CADSTREAM (K031779) | Confirma, Inc. | 2003-08-06 |
| NANMA ADJUSTABLE CONSTRICTION RING (K030119) | Nanma Mfg Co., Ltd. | 2003-08-06 |
| PRECISET TDM I AND PRECISET TDM II CALIBRATORS (K031856) | Roche Diagnostics Corp. | 2003-08-06 |
| TRI-LOOP MICROWAVE ABLATION PROBE (K032047) | Vivant Medical, Inc. | 2003-08-06 |
| BENCO ADMIX (K032152) | Southern Dental Industries, Inc. | 2003-08-06 |
| TOX AMMONIA CALIBRATOR (K031683) | Bayer Healthcare, LLC | 2003-08-06 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML (K031943) | Becton, Dickinson & CO | 2003-08-06 |
| CARDIOQ, MODEL 9051-7005 (K031706) | Deltex Medical | 2003-08-06 |
| HEMOGLOBIN A1C REAGENT SET (K031539) | Pointe Scientific, Inc., | 2003-08-06 |
| CARRIER TIPS (K031461) | Dentsply Intl. | 2003-08-05 |
| TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM (K031786) | Vision-Sciences, Inc. | 2003-08-05 |
| UNITY NETWORK IS PATIENT VIEWER (K032346) | Ge Medical Systems Information Technologies | 2003-08-05 |
| OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 (K031282) | LeMaitre Vascular, Inc. | 2003-08-05 |
| PRECISET DAT PLUS I CALIBRATORS (K031775) | Roche Diagnostics Corp. | 2003-08-05 |
| ELECSYS SHBG IMMUNOASSAY (K031717) | Roche Diagnostics Corp. | 2003-08-05 |
| TINA-QUANT CRP (LATEX) (K032336) | Roche Diagnostics Corp. | 2003-08-05 |
| LIFESYNE SYSTEMS (K030795) | Gmp/Companies, Inc. | 2003-08-05 |
| COLTOSOL F (K031752) | Coltene/Whaledent, Inc. | 2003-08-05 |
| PULPDENT ETCH-RITE ROYALE (K031915) | Pulpdent Corporation | 2003-08-05 |
| DIGITAL TEMPERATURE MONITOR; MODEL KY-01 (K030219) | Kang Ying Medical Appliances, Inc. | 2003-08-05 |
| ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS (K031472) | Lifescan, Inc. | 2003-08-05 |
| SAFEPRO PLUS SAFETY SYRINGE (K031830) | Formosa Medical Devices, Inc. | 2003-08-05 |
| PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 (K023548) | Velocimed | 2003-08-04 |
| SQUEEZE-EASE MAMMOGRAPHY CUSHION (K031574) | S & S X-Ray Products, Inc. | 2003-08-04 |
| GLUCOLEADER VALUE (K023279) | Hmd Biomedical, Inc. | 2003-08-04 |
| ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD (K031759) | ACON Laboratories, Inc. | 2003-08-04 |
| BONESOURCE BVF (K031435) | Howmedica Osteonics | 2003-08-04 |
| COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D (K014241) | Alsius Corp. | 2003-08-01 |
| AURORA DS (K031988) | Syneron Medical, Ltd. | 2003-08-01 |
| DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I (K032202) | Planar Systems, Inc. | 2003-08-01 |
| R 72 (K030487) | Ralco S.R.L. | 2003-08-01 |
| TERUMO AL8X ARTERIAL FILTER WITH X-COATING (K032128) | Terumo Cardiovascular Systems Corp. | 2003-08-01 |
| EMBRACE WET-BOND RESTORATIVE MATERIAL (K031877) | Pulpdent Corporation | 2003-08-01 |
| XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000 (K031451) | Photo Medex, Inc. | 2003-08-01 |
| IQ HYDROPHILIC GUIDE WIRE (K032183) | Boston Scientific Corp | 2003-08-01 |
| DBT, DYNAMIC BUBBLE TRAP (K031323) | Convergenza AG | 2003-08-01 |
| WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 (K031582) | Nihon Seimitsu Sokki Co., Ltd. | 2003-08-01 |
| MEDRAD MANUAL SYRINGE LOADER (K031483) | Medrad, Inc. | 2003-08-01 |
| BALL RECORDING ELECTRODE/STIMULATION PROBE (K030517) | Viasys Healthcare, Inc. | 2003-08-01 |
| MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR (K031578) | Micrus Corp. | 2003-08-01 |
| ISOLETTE INFANT INCUBATOR, MODEL C2000E (K031387) | Hill-Rom Manufacturing, Inc. | 2003-08-01 |
| POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED (K031625) | Perusahaan Getah Asas Sdn. Bhd. | 2003-08-01 |
| VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM (K031641) | Vascular Architects, Inc. | 2003-08-01 |
| CARDIODIRECT, MODELS 12M, 12I, 12S (K024283) | Reynolds Medical , Ltd. | 2003-08-01 |
| BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED (K031768) | Perusahaan Getah Asas Sdn. Bhd. | 2003-08-01 |
| GUGLIELMI DETACHABLE COIL (GDC) (K031049) | Boston Scientific, Target | 2003-08-01 |
| CARDIOSOFT/CASE CARDIAC TESTING SYSTEM (K031561) | Ge Medical Systems Information Technologies | 2003-08-01 |
| HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II (K012715) | Hygia Health Services, Inc. | 2003-08-01 |
| MODIFICATION TO THERMACOOL TC SYSTEM (K032088) | Thermage, Inc. | 2003-08-01 |
| AURORA SR (K031993) | Syneron Medical, Ltd. | 2003-08-01 |
| DENTISEPTIC HPC (K031851) | Bethel, Inc. | 2003-08-01 |
| SK MED M201 PLUS MIXER (K031707) | Sk Med | 2003-08-01 |
| SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR (K031532) | Metro Optics of Austin, Inc. | 2003-08-01 |
| HEMOSIL FACTOR IX DEFICIENT PLASMA (K031829) | Instrumentation Laboratory CO | 2003-07-31 |
| MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB (K030671) | Medtronic Vascular | 2003-07-31 |
| NICHOLS ADVANTAGE ALDOSTERONE ASSAY (K032188) | Nichols Institute Diagnostics | 2003-07-31 |
| COACH 888 (K030758) | Wheelchair & Scooter Express | 2003-07-31 |
| SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (K031576) | Surgitech, Inc. | 2003-07-31 |
| KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320 (K031309) | Kuann Dah Industry Co., Ltd. | 2003-07-31 |
| LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) (K021362) | Organ Recovery Systems, Inc. | 2003-07-31 |
| FILMLESS CLINIC (K031704) | Connect Imaging, Inc. | 2003-07-31 |
| GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT (K031480) | Howmedica Osteonics Corp. | 2003-07-31 |
| SHOCKWAVE SUSPENSION WHEELCHAIR (K032123) | Per4max Medical, LLC | 2003-07-31 |
| RSV (RADIOLOGY SYSTEM VISIODENT (K031448) | Visiodent SA | 2003-07-31 |
| MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML) (K031602) | Dade Behring, Inc. | 2003-07-31 |
| EARLYDETECT MENOPAUSE TEST FOR FSH (K030058) | Early Detect, Inc. | 2003-07-30 |
| NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS (K030268) | C.R. Bard, Inc. | 2003-07-30 |
| PEEK TETRIS SPINAL IMPLANT (K031757) | Signus Medical, LLC | 2003-07-30 |
| CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 (K031534) | Scantibodies Laboratory, Inc. | 2003-07-30 |
| UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS (K031381) | Seaspine | 2003-07-30 |
| DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS (K031991) | Image Analysis, Inc. | 2003-07-30 |
| SAUFLON MULTIPURPOSE SOLUTION - NO RUB (K030278) | Sauflon Pharmaceuticals, Ltd. | 2003-07-30 |
| PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (K031727) | Pasco Laboratories, Inc. | 2003-07-30 |
| MR FIBER OPTIC ECG GATING SYSTEM (K031731) | Sa Instruments, Inc. | 2003-07-30 |
| AURORA (K032082) | Aurora Imaging Technology, Inc. | 2003-07-30 |
| MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES (K032058) | Alliance Medical Corp. | 2003-07-30 |
| MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 (K031411) | Mercury Medical | 2003-07-30 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML (K031699) | Becton, Dickinson & CO | 2003-07-30 |
| POWERHEART AED G3, MODEL 9300 (K031987) | Cardiac Science | 2003-07-30 |
| VERTE-STACK SPINAL SYSTEM (K031780) | Medtronic Sofamor Danek | 2003-07-30 |
| 8 CHANNEL CARDIAC PHASED ARRAY COIL (K032045) | GE Medical Systems | 2003-07-30 |
| SPIROSOFT (K031194) | Viasys Healthcare GmbH | 2003-07-30 |
| BIPAP HARMONY VENTILATORY SUPPORT SYSTEM (K031656) | Respironics, Inc. | 2003-07-30 |
| ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC (K032089) | Roche Diagnostics Corp. | 2003-07-30 |
| STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230) (K032062) | Stellartech Research Corp. | 2003-07-29 |
| REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE (K031550) | Vivometrics, Inc. | 2003-07-29 |
| BENCO SPHERICAL (K031658) | Southern Dental Industries, Inc. | 2003-07-29 |
| VIRTUOSAPH (K031891) | Terumo Cardiovascular Systems Corp. | 2003-07-29 |
| MIX2VIAL TRANSFER DEVICE (K031861) | Medimop Medical Projects, Ltd. | 2003-07-29 |
| BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR (K031647) | Getinge USA, Inc. | 2003-07-29 |
| GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR (K032007) | Pt. Wrp Buana Multicorpora | 2003-07-28 |
| OSSEOTITE NT CERTAIN IMPLANTS (K031475) | Implant Innovations, Inc. | 2003-07-28 |
| SINCLAIR WOUND AND SKIN EMULSION (K024367) | Sinclair Pharmaceuticals, Ltd. | 2003-07-28 |
| AIRBRUSH LIPOSCULPTOR SYSTEM (K031881) | Biosculpture Technology, Inc. | 2003-07-28 |
| DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT (K031969) | DePuy Orthopaedics, Inc. | 2003-07-28 |
| REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 (K030170) | Opus Medical, Inc. | 2003-07-28 |