| TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 (K010578) | Taga Medical Technologies, Inc. | 2001-04-25 |
| BABY DOPPLEX 3002 (BD3002) (K010894) | Huntleigh Healthcare, Inc. | 2001-04-25 |
| CRANIAL MOLDING ORTHOSIS (K010273) | Orthotic Solutions, Inc. | 2001-04-25 |
| PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST (K011116) | Pasco Laboratories, Inc. | 2001-04-24 |
| TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (K003558) | Siemens Hearing Instruments, Inc. | 2001-04-24 |
| MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K010536) | Oxoid , Ltd. | 2001-04-24 |
| DOSIMETRY CHECK (K010225) | Math Resolutions, LLC | 2001-04-24 |
| LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K010537) | Oxoid , Ltd. | 2001-04-24 |
| VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 (K010550) | bioMerieux, Inc. | 2001-04-24 |
| EUROSPITAL EU-TTG IGA UMANA (K010625) | Scimedx Corp. | 2001-04-24 |
| ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX (K000442) | Medical Concepts Development, Inc. | 2001-04-24 |
| ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS (K011081) | Exactech, Inc. | 2001-04-24 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K010627) | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-04-24 |
| TAKE ONE BITE MODIFIED (K010994) | Kerr Corp. | 2001-04-23 |
| POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K010626) | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-04-23 |
| SYNTHES SYNMESH SPACER SYSTEM (K003275) | Synthes (Usa) | 2001-04-23 |
| SHIELDING NEEDLE HOLDER (K003381) | U.S. Safety Syringes Co., Inc. | 2001-04-23 |
| MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (K010709) | Mentor Corp. | 2001-04-23 |
| POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K010628) | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2001-04-23 |
| PASCO MIC AND MIC/ID PANELS (K010508) | Pasco Laboratories, Inc. | 2001-04-23 |
| NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES (K010969) | Stryker Instruments | 2001-04-20 |
| SYNPLUG (K010840) | Isotis NV | 2001-04-20 |
| ORIGEN BLADDER HOLDER (K003145) | Origen Biomedical, Inc. | 2001-04-20 |
| OPTIMA (K011053) | Medical Industries America, Inc. | 2001-04-20 |
| MODIFICATION TO CAVERMAP SURGICAL AID (K010213) | Uromed Corp. | 2001-04-20 |
| NUMED HIGH PRESSURE PTA CATHETERS (K010880) | NuMED, Inc. | 2001-04-20 |
| EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 (K010934) | Syva Co., Dade Behring, Inc. | 2001-04-20 |
| RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS (K003809) | Rapid Diagnostics, Inc. | 2001-04-20 |
| DIMENSION CTNI CALIBRATOR (K010314) | Dade Behring, Inc. | 2001-04-20 |
| SAFESTING AND SAFESTING HUB (K011003) | Diasol, Inc. | 2001-04-20 |
| CAVITY VARNISH (K010255) | Rite-Dent Manufacturing Corp. | 2001-04-20 |
| SOFTLASE - SURGICAL DIODE LASER SYSTEM (K003440) | Zap Lasers, Inc. | 2001-04-20 |
| MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, (K010341) | Medtronic PS Medical | 2001-04-20 |
| SONOTOME ULTRASONIC ASPIRATOR TIPS (K010637) | Synergetics, Inc. | 2001-04-20 |
| SIMPLICITY SOFT QD EASY INFUSION SET (K010788) | Sterling Medivations, Inc. | 2001-04-20 |
| DIMENSION CTNI FLEX REAGENT CARTRIDGE (K010313) | Dade Behring, Inc. | 2001-04-20 |
| BEAUTIFIL (K010914) | Shofu Dental Corp. | 2001-04-20 |
| EMIT 2000 GENTAMICIN PLUS ASSAY (K010984) | Syva Co., Dade Behring, Inc. | 2001-04-20 |
| DISPO-MED 7.6 LITER SHARPS CONTAINER (K003521) | Master Benefits, Inc. | 2001-04-19 |
| BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM) (K010890) | Becton, Dickinson and Co. | 2001-04-19 |
| MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 (K010878) | Diagnostic Products Corp. | 2001-04-18 |
| SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR (K010309) | Mutoh America Co., Ltd. | 2001-04-18 |
| DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS (K010810) | DePuy Orthopaedics, Inc. | 2001-04-18 |
| TEMP SCAN (K010383) | Tenghi Co., Ltd. | 2001-04-18 |
| TRAY ADAPTERS, MULTIPLE (K010174) | Arplay Medical S.A. | 2001-04-18 |
| CLS VARUS STEM/CLS 135 STEM (K010839) | Sulzer Orthopedics, Inc. | 2001-04-18 |
| LEAD BLOCKS (K010172) | Arplay Medical S.A. | 2001-04-18 |
| AB CARDIETTE START 200 HV (K010822) | H&C Medical Devices Spa | 2001-04-18 |
| MODIFICATION TO OSTEONICS SPINAL SYSTEM (K010845) | Howmedica Osteonics Corp. | 2001-04-18 |
| GUIDER SOFTIP GUIDING CATHETER XF 5F (K010853) | Boston Scientific, Target | 2001-04-18 |
| TRIDENT POROUS TITANIUM ACETABULAR COMPONENT (K010170) | Howmedica Osteonics Corp. | 2001-04-18 |
| DORNIR LC-1 CPAP SYSTEM (K010704) | Prym Medical , Ltd. | 2001-04-18 |
| ILT DEFLECTING CATHETER, MODEL C114ND1 (K010531) | Intra Luminal Therapeutics, Inc. | 2001-04-18 |
| SIMPLICITY WINGED QD INFUSION SET (K010676) | Sterling Medivations, Inc. | 2001-04-18 |
| OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD (K002036) | Osi Medical, Inc. | 2001-04-17 |
| Y-TZP POWDER AND PROCERA ALLZIRKON (K010630) | Procera Sandvik, Inc. | 2001-04-17 |
| FG-36UX, FIBER ULTRASOUND GASTROSCOPE (K010740) | Pentax Precision Instrument Corp. | 2001-04-17 |
| LIVESURE COCAINE SCREEN TEST (K010967) | Pan Probe Biotech, Inc. | 2001-04-17 |
| WUJIN #3 FEMORAL NAIL (K010149) | Biopro, Inc. | 2001-04-17 |
| INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 (K003561) | Invacare Corp. | 2001-04-17 |
| PREMIER ULTRASONIC SCALER AND INSERTS (K010195) | Premier Dental Products Co. | 2001-04-17 |
| DORNIER COMPACT ALPHA LITHOTRIPTER (K002929) | Dornier Medtech America, Inc. | 2001-04-17 |
| REFLEX ANTERIOR CERVICAL PLATE SYSTEM (K010115) | Howmedica Osteonics Corp. | 2001-04-16 |
| ADVIA CENTAUR RUBELLA IGG ASSAY (K003412) | Bayer Corp. | 2001-04-13 |
| COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 (K010765) | Beckman Coulter, Inc. | 2001-04-13 |
| PRESCOTT'S SURGICAL SPEAR (K003842) | Prescott'S, Inc. | 2001-04-13 |
| SIMPLICITY INFUSER INFUSION SET (K010647) | Sterling Medivations, Inc. | 2001-04-13 |
| NIAGARA SLIM-CATH (K010778) | C.R. Bard, Inc. | 2001-04-13 |
| IL TEST FREE PROTEIN S (K010379) | Instrumentation Laboratory CO | 2001-04-13 |
| 3M ESPE HAUR (K010781) | 3M Company | 2001-04-13 |
| WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 (K010421) | Wiener Laboratories Saic | 2001-04-13 |
| COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X (K010956) | Boston Scientific Corp | 2001-04-13 |
| EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 (K010812) | Syva Co., Dade Behring, Inc. | 2001-04-13 |
| KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES (K003994) | KARL STORZ Endoscopy-America, Inc. | 2001-04-13 |
| LACTOSORB ETHMOID STENT (K002131) | Walter Lorenz Surgical, Inc. | 2001-04-13 |
| VERDICT -II BAR; VERDICT -II BZO (K010959) | Medtox Diagnostics, Inc. | 2001-04-13 |
| AVL HINGE KNEE SYSTEM (K010774) | Biomet, Inc. | 2001-04-13 |
| EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 (K010814) | Syva Co., Dade Behring, Inc. | 2001-04-13 |
| ANEUVYSION MULITICOLOR DNA PROBE KIT (K010288) | Vysis | 2001-04-13 |
| LIVESURE MORPHINE SCREEN TEST (K011011) | Pan Probe Biotech, Inc. | 2001-04-13 |
| RX HERCULINK PLUS BILIARY STENT SYSTEM (K010684) | Guidant Corp. | 2001-04-12 |
| U04 (K010942) | Siemens Medical Solutions USA, Inc. | 2001-04-12 |
| MOSS MIAMI 5.5MM TITANIUM PIN NUT (K010742) | Depuyacromed | 2001-04-12 |
| VISTAKON (METHAFILCON A) CONTACT LENSES (K010507) | Vistakon | 2001-04-12 |
| CH 2000 CARDIAC DIAGNOSTIC SYSTEM (K010756) | Cambridge Heart, Inc. | 2001-04-12 |
| UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET (K000592) | Myco Medical Supplies, Inc. | 2001-04-12 |
| LASER MECHANISMS LASER SCANNING SYSTEM (K010113) | Laser Mechanisms, Inc. | 2001-04-12 |
| HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS (K010758) | Cambridge Heart, Inc. | 2001-04-12 |
| SIMPLICITY SILVER SET SOFT INFUSION (K010846) | Sterling Medivations, Inc. | 2001-04-12 |
| R-SI-LINE METAL-BITE (K010926) | R-Dental Dentalerzeugnisse GmbH | 2001-04-12 |
| CANDELA LONG PULSE ND:YAG (K010104) | Candela Corp. | 2001-04-11 |
| AT WORK DRUG TEST, MODEL 9147T AWT (K010836) | Phamatech | 2001-04-11 |
| UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 (K010296) | Marina Medical Instruments, Inc. | 2001-04-11 |
| TSRH SPINAL SYSTEM (K010720) | Medtronic Sofamor Danek, Inc. | 2001-04-11 |
| AT WORK DRUG TEST, MODEL 9177T AWT (K010833) | Phamatech | 2001-04-11 |
| LFIT V40 FEMORAL HEAD COMPONENTS (K010757) | Howmedica Osteonics Corp. | 2001-04-11 |
| CAPNOPROBE SL, MODEL 2000 (K010795) | Optical Sensors, Inc. | 2001-04-11 |
| BIPOLAR TRIGGER-FLEX PROBE (K003126) | Ellman Intl., Inc. | 2001-04-11 |
| FIESTA IMAGING OPTION (K002997) | GE Medical Systems | 2001-04-11 |
| VIGIL DNASE B CONTROL (K010693) | Beckman Coulter, Inc. | 2001-04-11 |