| SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM (K012253) | Aloka Co., Ltd. | 2001-08-30 |
| INSIGHT GENESIS (K011983) | Fasstech | 2001-08-30 |
| HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR (K011745) | Transworld Mobility Distribution, LLC | 2001-08-30 |
| VECTORVISION CT/FLUORO (K010968) | Brainlab AG | 2001-08-30 |
| TRANSLUX ENERGY (K012341) | Heraeus Kulzer, Inc. | 2001-08-30 |
| PALOMAR LC 100 DIODE LASER (K011747) | Palomar Medical Technologies, Inc. | 2001-08-30 |
| VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K012593) | Ortho-Clinical Diagnostics, Inc. | 2001-08-30 |
| JET THERAPY (K002908) | Jet Therapy | 2001-08-30 |
| OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND (K011769) | Opusdent , Ltd. | 2001-08-30 |
| ATRICURE BIPOLAR COAGULATION SYSTEM (K011722) | AtriCure, Inc. | 2001-08-30 |
| E-SCAN MRI SYSTEM (K012728) | Biosound Esaote, Inc. | 2001-08-29 |
| LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES (K011703) | Lumenis | 2001-08-29 |
| SOLO-SAFE SAFETY SYRINGE, SIZE-3CC (K003555) | Spectrum Biotech, Inc. | 2001-08-29 |
| VULCAN TAC PROBES, MODEL 911XXX (K003198) | Oratec Interventions, Inc. | 2001-08-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS (K012561) | Ortho-Clinical Diagnostics | 2001-08-29 |
| ELK LASER IMAGER, MODEL EL-DRY 4000 (K011949) | Nishimoto Sangyo Co., Ltd. | 2001-08-29 |
| HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K012151) | Trek Diagnostic Systems, Inc. | 2001-08-29 |
| ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 (K012493) | Exactech, Inc. | 2001-08-29 |
| LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 (K012513) | Bio-Rad | 2001-08-29 |
| VIEWSTATION (K011694) | Impac Medical Systems, Inc. | 2001-08-29 |
| BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET (K011984) | Becton, Dickinson & CO | 2001-08-29 |
| SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM (K012080) | Aloka Co., Ltd. | 2001-08-29 |
| BI-PHASIC INFILTRATOR (K012044) | Reliance Medical Corp. | 2001-08-28 |
| ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM (K012130) | Medtronic Vascular | 2001-08-28 |
| SNIPER ELITE MODEL-OR-E3872XX SERIES (K011905) | Maxxim Medical | 2001-08-28 |
| ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218 (K012083) | Medtronic Vascular | 2001-08-28 |
| MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS (K011844) | Merits Health Products., Inc. | 2001-08-28 |
| TRULINE INFUSION CATHETERS (K011937) | Micro Therapeutics, Inc. | 2001-08-28 |
| WH ACCU TEST PREGNANCY TEST (K012284) | W.H.P.M., Inc. | 2001-08-28 |
| ACCU-PULSE TENS UNIT (K010203) | Sadler Electronics | 2001-08-28 |
| ORTELIUS 800 (K011827) | Orthoscan , Ltd. | 2001-08-28 |
| COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 (K012431) | Bionostics, Inc. | 2001-08-28 |
| POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) (K002172) | Xiros Plc | 2001-08-28 |
| ATTAIN 6215 VENOGRAM BALLOON CATHETER (K012225) | Medtronic Vascular | 2001-08-28 |
| TERUMO 30 GAUGE HYPODERMIC NEEDLE (K012646) | Terumo Medical Corp. | 2001-08-27 |
| PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM (K010411) | Cordis Corp. | 2001-08-27 |
| MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 (K012430) | Bionostics, Inc. | 2001-08-27 |
| EZ SET INFUSION SET (K012754) | Animas Corp. | 2001-08-27 |
| OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, (K011886) | Olympus America, Inc. | 2001-08-27 |
| GPW-SF (K011659) | Gateway Alloys, Inc. | 2001-08-27 |
| TAO EMBRYO TRANSFER CATHETER SYSTEM (K012220) | Ttj Biomedical, LLC | 2001-08-27 |
| MACROPORE IB RESORBABLE PLUG (K011715) | Macropore Biosurgery, Inc. | 2001-08-27 |
| NEUROEDGE INFUSION CATHETER (K011646) | Neuro Vasx, Inc. | 2001-08-27 |
| SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR (K002328) | Richard Wolf Medical Instruments Corp. | 2001-08-27 |
| HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR (K011657) | Mick Radio-Nuclear Instruments, Inc. | 2001-08-27 |
| DRI ECSTASY URINE CALIBRATORS (K012109) | Microgenics Corp. | 2001-08-27 |
| DIRECT BILIRUBIN REAGENT (K011972) | Intersect Systems, Inc. | 2001-08-27 |
| ERIS LAYERING MATERIALS (K012174) | Ivoclar North America, Inc. | 2001-08-27 |
| CONCORD 88 (K011661) | Gateway Alloys, Inc. | 2001-08-27 |
| POINT 4 FLOWABLE (K012321) | Sybron Dental Specialties, Inc. | 2001-08-27 |
| CLAY-PARK LABS, INC. - LUBRICATING JELLY (K012203) | Clay-Park Labs, Inc. | 2001-08-27 |
| DRI ECSTASY ENZYME IMMUNOASSAY (K012110) | Microgenics Corp. | 2001-08-27 |
| MAVIDON MEDICAL ELECTRODE JELLY (K003924) | Mavidon Medical Products | 2001-08-24 |
| VAXCEL DIALYSIS CATHETER (K012365) | Boston Scientific Corp | 2001-08-24 |
| FORTAFLEX SURGICAL MESH (K011025) | Organogenesis, Inc. | 2001-08-24 |
| ULTRACELL ABSORBENT STICK (K012196) | Ultracell Medical Technologies, Inc. | 2001-08-24 |
| DISPOSABLE VITRECTOMY LENS (K012096) | Ocular Instruments, Inc. | 2001-08-24 |
| FLEX-NAILS (K012161) | Fixano SA | 2001-08-24 |
| GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS (K011072) | Gelflex | 2001-08-24 |
| MB 11 (K011746) | Maico Diagnostic GmbH | 2001-08-24 |
| THE SPIN SNAP-OFF SCREW (K011946) | New Deal, S.A. | 2001-08-24 |
| EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) (K012445) | Electro Medical Systems SA | 2001-08-24 |
| MODIFICATION TO ELECSYS FSH II CALSET (K012399) | Roche Diagnostics Corp. | 2001-08-24 |
| AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600 (K002339) | Apex Medical Corp. | 2001-08-24 |
| QUIK-CHECK OVULATION PREDICTOR (K012252) | ACON Laboratories, Inc. | 2001-08-24 |
| RANDOX HUMAN ASSSAYED DRUG CONTROL (K012319) | Randox Laboratories, Ltd. | 2001-08-24 |
| HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR (K011744) | Transworld Mobility Distribution, LLC | 2001-08-24 |
| LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM (K010918) | Medtronic Physio-Control Corp. | 2001-08-23 |
| ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM (K010772) | Imaging Services, Inc. | 2001-08-23 |
| MODIFICATION TO VASCULAR CLOSURE DEVICE (K012362) | Std Mfg., Inc. | 2001-08-23 |
| MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT (K012567) | Corgenix, Inc. | 2001-08-23 |
| HI-WAVE; POUR-PLUS (K011762) | Denplus, Inc. | 2001-08-23 |
| LUXACORE/LUXACORE DUAL (K012307) | Dmg USA, Inc. | 2001-08-23 |
| PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K012347) | Sulzer Intratherapeutics, Inc. | 2001-08-23 |
| MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER (K012374) | Astra Tech, Inc. | 2001-08-23 |
| TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE (K012538) | Medtronic Vascular | 2001-08-23 |
| PERMACEM / PERMACEM DUAL (K012316) | Dmg USA, Inc. | 2001-08-23 |
| STRAUMANN GBR SYSTEM (K011698) | Institut Straumann AG | 2001-08-23 |
| RADIUS NEXT GENERATION GUIDEWIRE (K011759) | Radius Medical Technologies, Inc. | 2001-08-23 |
| GE LOGIQ A100 MP, MODEL 2272413 (K012560) | General Electric Co. | 2001-08-23 |
| AVANTE MICRO CRYSTAL SYSTEM (K012231) | Jeneric/Pentron, Inc. | 2001-08-23 |
| EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 (K011941) | The Kendall Company | 2001-08-22 |
| BRIDGE FX (K011817) | Medtronic Ave, Inc. | 2001-08-22 |
| MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR (K012310) | Health & Life Co., Ltd. | 2001-08-22 |
| LIGHTLAS 532 PHOTOCOAGULATOR (K010372) | Lightmed Corp. | 2001-08-22 |
| ORTHO DEVELOPMENT ORION-I EMF SYSTEM (K012129) | Ortho Development Corp. | 2001-08-22 |
| RADIOGRAPHIC MARKERS (K011856) | Encore Orthopedics, Inc. | 2001-08-22 |
| DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K010418) | Dade Behring, Inc. | 2001-08-22 |
| JEL-20 (K012303) | J.F. Jelenko & Co., Inc. | 2001-08-22 |
| ITI DENTAL IMPLANT SYSTEM (K012757) | Straumann USA | 2001-08-22 |
| MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES (K012533) | Osi Medical, Inc. | 2001-08-22 |
| PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI (K011604) | Ge Medical Systems, Inc. | 2001-08-22 |
| SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW (K012224) | Ranfac, Corp. | 2001-08-22 |
| MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE (K011811) | Merit Medical Systems, Inc. | 2001-08-22 |
| LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS (K011749) | Sempermed USA, Inc. | 2001-08-22 |
| CRYOPLAN SYSTEM (K011073) | Cryomedical Sciences, Inc. | 2001-08-22 |
| SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1 (K001853) | Medtech Systems, Inc. | 2001-08-22 |
| MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM (K012305) | Sulzer Spine-Tech | 2001-08-22 |
| SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES (K012104) | Beijing Reagent Latex Products Co., Ltd. | 2001-08-21 |
| MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR (K011991) | Medrad, Inc. | 2001-08-21 |