| POWER 5000 GENERAL PURPOSE COIL (K002483) | Usa Instruments, Inc. | 2000-10-25 |
| FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER (K003094) | Qualigen, Inc. | 2000-10-25 |
| PIPER (K001295) | Rtek Medical Systems, LLC | 2000-10-25 |
| BURR HOLE COVER, MODEL XX (K001096) | Image-Guided Neurologics, Inc. | 2000-10-25 |
| STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (K994321) | Automatic Liquid Packaging, Inc. | 2000-10-25 |
| SOMATOM SMILE (K003152) | Siemens Medical Solutions USA, Inc. | 2000-10-24 |
| MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW (K003091) | Medline Industries, Inc. | 2000-10-24 |
| DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL (K002975) | Wrp Specialty Products Sdn. Bhd. | 2000-10-24 |
| EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR (K000739) | Otto Bock Orthopedic Industry, Inc. | 2000-10-24 |
| RADIOMED SOURCE (K001070) | Radiomed Corp. | 2000-10-24 |
| HEATED HUMIDIFIER (K983783) | Pegasus Research Corp. | 2000-10-24 |
| SIMPLICITY SOFT INFUSION SET (K002492) | Sterling Medivations, Inc. | 2000-10-24 |
| PDT DOSECALCULATOR, MODEL 80000 (K000418) | Retinalabs.Com | 2000-10-24 |
| ELRAN 01 SYSTEM (K002431) | Envision Advanced Medical System, Ltd. | 2000-10-24 |
| ANSPACH ANGLED MICRONOSE ATTACHMENT (K002903) | The Anspach Effort, Inc. | 2000-10-24 |
| EQUITY (K002826) | Jensen Industries, Inc. | 2000-10-24 |
| LIFE SCOPE P, MODEL BSM-4100 SERIES (K001693) | Nihon Kohden America, Inc. | 2000-10-24 |
| VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX (K002284) | Invacare Corp. | 2000-10-24 |
| NEUROMAP WITH NEURO 100 (K002773) | Radionics, Inc. | 2000-10-23 |
| KSEA NEURO-FIBERSCOPE (K002788) | KARL STORZ Endoscopy-America, Inc. | 2000-10-23 |
| THERMAL CAUTERY UNIT, MODEL 150 (K002341) | Geiger Medical Technologies, Inc. | 2000-10-23 |
| WHEELCHAIR, MECHANICAL SERIES MODEL 3100 (K002943) | Mada Medical Products, Inc. | 2000-10-23 |
| RADIONICS RF DISC CATHETER ELECTRODE SYSTEM (K001741) | Radionics, Inc. | 2000-10-23 |
| AERO-CLICK (K993094) | Map Medizintechnik Fur Arzt Und Patient GmbH | 2000-10-23 |
| ELECSYS CA 15-3 TEST SYSTEM (K001468) | Roche Diagnostics Corp. | 2000-10-23 |
| MR-III (K002261) | Smith & Nephew, Inc. | 2000-10-23 |
| RE-ENTRANT CHAMBER, MODEL 1008 OR 44D (K002446) | Sun Nuclear Corp. | 2000-10-23 |
| BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY (K002389) | Baylis Medical Co., Inc. | 2000-10-23 |
| REUSABLE CANNULA (K002542) | Genicon, LC | 2000-10-23 |
| ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG (K002631) | Eemagine Medical Imaging Solutions GmbH | 2000-10-23 |
| X-POSURE SYSTEM VERSION 2 RAD (K002500) | Pronosco A/S | 2000-10-23 |
| BIOSLEEP (K002622) | Oxford Biosignals Limited | 2000-10-23 |
| DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000838) | P.T. Healthcare Glovindo | 2000-10-23 |
| BROOKER FEMORAL NAILS (K002278) | Biomet Orthopedics, Inc. | 2000-10-23 |
| OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION (K002589) | Alcon Universal, Ltd. | 2000-10-23 |
| MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM (K002980) | Ebi, L.P. | 2000-10-23 |
| DMLC IV-ERGO (K001163) | 3D Line USA, Inc. | 2000-10-23 |
| DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES (K001990) | Depilase Group , Ltd. | 2000-10-23 |
| DURAGARD SODIUM FLUORIDE VARNISH (K002581) | Sultan Dental Products, Ltd. | 2000-10-20 |
| NICHOLS ADVANTAGE THYROGLOB (K002888) | Nichols Institute Diagnostics | 2000-10-20 |
| DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K002814) | Shanghai PM Plastics Enterise Co., Ltd. | 2000-10-20 |
| SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM (K003125) | Siemens Medical Solutions USA, Inc. | 2000-10-20 |
| VISIJET HYDROKERATOME, MODEL 50 (K991124) | Visijet, Inc. | 2000-10-20 |
| WACKERS-LIU CQ SOFTWARE (K002229) | Eclipse Systems, Inc. | 2000-10-20 |
| RADIOCAMERAS EXTRACRANIAL SYSTEM (K000246) | Surgical Navigation Technologies, Inc. | 2000-10-20 |
| MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC (K002949) | Datascope Corp. | 2000-10-20 |
| DA VINCHI EEG AND EMG/EP SYSTEMS (K000963) | Airsep Corp. | 2000-10-20 |
| BACT/ALERT CSR (K003104) | Organon Teknika Corp. | 2000-10-20 |
| STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR (K002547) | Starion Instruments | 2000-10-20 |
| PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION (K001646) | Puritan Bennett Corp. | 2000-10-20 |
| BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE) (K994276) | Biopro (M) Sdn Bhd | 2000-10-20 |
| LACTOSORB PUSH SCREW (K002423) | Biomet, Inc. | 2000-10-20 |
| MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS (K003121) | Medison America, Inc. | 2000-10-20 |
| BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE) (K994281) | Biopro (M) Sdn Bhd | 2000-10-20 |
| CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES (K994320) | Cantor & Silver , Ltd. | 2000-10-20 |
| GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM (K002169) | Scimedx Corp. | 2000-10-19 |
| MDI GLIADIN A TEST (K002358) | Micro Detect, Inc. | 2000-10-19 |
| TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 (K002257) | Tecno Instruments (Pvt.) , Ltd. | 2000-10-19 |
| STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES (K002933) | Maxxim Medical | 2000-10-19 |
| GLOBAL SPINAL FIXATION SYSTEM (K001668) | D.K.M. Co., Ltd. | 2000-10-19 |
| THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD (K001795) | Avitro, LLC | 2000-10-19 |
| BIOMESH P1 AND BIOMESH PLUG AND PATCH (K002479) | Cousin Biotech S.A.R.L | 2000-10-19 |
| SPIRIT ACUPUNCTURE NEEDLE (K003010) | United Pacific Co., Ltd. | 2000-10-19 |
| M2376A DEVICELINK SYSTEM (K003107) | Agilent Technologies, Inc. | 2000-10-19 |
| SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE (K003225) | Baxter Healthcare Corp | 2000-10-19 |
| GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM (K002189) | Scimedx Corp. | 2000-10-19 |
| JEL BIOS PURE (K002645) | J.F. Jelenko & Co., Inc. | 2000-10-19 |
| MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER (K002613) | Nova Biomedical Corp. | 2000-10-19 |
| VITREA 2, VERSION 2.1 (K002519) | Vital Images, Inc. | 2000-10-19 |
| MDI GLIADIN G TEST (K002359) | Micro Detect, Inc. | 2000-10-19 |
| HARDYDISK NETILMICIN, 30MCG (K002663) | Hardy Diagnostics | 2000-10-19 |
| MACROPOREMX MANDIBULAR FIXATION SYSTEM (K000696) | Macropore Biosurgery, Inc. | 2000-10-19 |
| 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE (K000632) | Avitro, LLC | 2000-10-19 |
| TREPCHEK TREPONEMAL ANTIBODY EIA (K001552) | Phoenix Biotech Corp. | 2000-10-19 |
| LUMALITE CURE LIGHT, MODEL 2100 (K002566) | Lumalite, Inc. | 2000-10-19 |
| IMPOAID (K000730) | Impoaid, Inc. | 2000-10-19 |
| JETCAN HUBER NEEEDLE SET (K002471) | Pfm Produkte Fur Die Medizin AG | 2000-10-19 |
| ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER (K002905) | Beckman Coulter, Inc. | 2000-10-19 |
| ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E (K002686) | Nellcor Puritan Bennett, Inc. | 2000-10-18 |
| SUREONE INSULIN SYRINGE (K002921) | Hosuk Co., Ltd. | 2000-10-18 |
| KSEA UNIMAT 12 (K002700) | KARL STORZ Endoscopy-America, Inc. | 2000-10-18 |
| SOLAR SPO2 MODULE WITH MASIMO SET (K002957) | General Electric Medical Systems Information Techn | 2000-10-18 |
| PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES (K002849) | Surgical Specialties Corp | 2000-10-18 |
| M2376A DEVICELINK SYSTEM, MODEL M2376A (K002967) | Agilent Technologies, Inc. | 2000-10-18 |
| PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V (K002204) | Pace Medical | 2000-10-18 |
| GUNTHER TULIP VENA CAVA MREYE FILTER SET (K000855) | Cook, Inc. | 2000-10-18 |
| PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 (K002444) | Sun Nuclear Corp. | 2000-10-18 |
| COLLAGEN WOUND DRESSING (K002443) | Oasis Research, LLC | 2000-10-18 |
| MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM (K003090) | Midmark Corp. | 2000-10-18 |
| EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 (K002534) | Eupalamus, LLC | 2000-10-18 |
| NAVIGUS PEEL AWAY INTRODUCER (K002330) | Image-Guided Neurologics, Inc. | 2000-10-18 |
| TRANSQ3 (K001522) | Iomed, Inc. | 2000-10-18 |
| SMARTLENS (K002510) | Odc Ophthalmic Development Co. AG | 2000-10-18 |
| XPS NITRO SYSTEM (K002828) | Xomed, Inc. | 2000-10-17 |
| SMALL STATURE USS (K994121) | Synthes (Usa) | 2000-10-17 |
| HITACHI ALTAIRE (K002420) | Hitachi Medical Systems America, Inc. | 2000-10-17 |
| RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION (K002823) | Bausch & Lomb, Inc. | 2000-10-17 |
| CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST (K002898) | Curon Medical, Inc. | 2000-10-17 |
| HEADBAND FOR BAHA (K002913) | Entific Medical Systems, Inc. | 2000-10-17 |
| MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM (K002936) | Sectra-Imtec AB | 2000-10-17 |