| PROLITE PULSED LIGHT SYSTEM (K000929) | Medical Bio Care Sweden AB | 2000-10-17 |
| INSIGHT 4000 ENDOSCOPE (K000252) | Insight Instruments Mfg., Inc. | 2000-10-17 |
| VISION 9000 PHASED ARRAY TORSO COIL (K002482) | Usa Instruments, Inc. | 2000-10-17 |
| FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS (K002198) | Fluoro Scan Imaging Systems, Inc. | 2000-10-17 |
| AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS (K002408) | Unilens Corp., USA | 2000-10-17 |
| OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS) (K002922) | Omnigrace (Thailand) , Ltd. | 2000-10-16 |
| MODIFICATION TO ISOBAR SPINAL SYSTEM (K002959) | Encore Orthopedics, Inc. | 2000-10-16 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K002870) | Shanghai PT Plastics Enterprise Company, Ltd. | 2000-10-16 |
| FOCUS (K002147) | Computerized Medical Systems, Inc. | 2000-10-13 |
| COALIZA PROTEIN S-FREE (K002467) | Instrumentation Laboratory CO | 2000-10-13 |
| CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 (K994059) | Hdc Corp. | 2000-10-13 |
| AUTOSTAT II ENA-6 PROFILE ELISA (K003054) | Cogent Diagnotics , Ltd. | 2000-10-13 |
| TC-PLUS SOLUTION KNEE (K000666) | Plus Orthopedics | 2000-10-13 |
| SAFE MINI (K980974) | Polystan A/S | 2000-10-13 |
| XIA SPINE SYSTEM (K002858) | Howmedica Osteonics Corp. | 2000-10-13 |
| SIMPLICITY DISPOSABLE PEN NEEDLE (K002180) | Sterling Medivations, Inc. | 2000-10-13 |
| BVI SLING (K002233) | Bio-Vascular, Inc. | 2000-10-13 |
| MODIFICATION TO YASARGIL ANEURYSM CLIPS (K002871) | Aesculap, Inc. | 2000-10-13 |
| ENDOCARE PERCUTANEOUS ACCESS SET (K002396) | Endocare, Inc. | 2000-10-13 |
| C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET (K002651) | Pointe Scientific, Inc., | 2000-10-13 |
| ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE (K002168) | Ronvig Instruments, Ltd. | 2000-10-13 |
| ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 (K002909) | Acrymed, Inc. | 2000-10-13 |
| AERONEB PORTABLE NEBULIZER (K003022) | Aerogen, Inc. | 2000-10-13 |
| AUTOSTAT II ENA-4 PROFILE ELISA (K003057) | Cogent Diagnotics , Ltd. | 2000-10-13 |
| ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER (K001578) | AngioDynamics, Inc. | 2000-10-13 |
| PACIFIER THERMOMETER MODELS VT-901F, VT901C (K002562) | Valeo Corp. | 2000-10-13 |
| PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K002883) | DePuy Orthopaedics, Inc. | 2000-10-13 |
| HL168B (K002882) | Health & Life Co., Ltd. | 2000-10-13 |
| INVERNESS MEDICAL OVULATION PREDICTOR TEST (K002867) | Selfcare, Inc. | 2000-10-12 |
| BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER (K002855) | Biocare Corp. | 2000-10-12 |
| SMITH & NEPHEW PORPS & TORPS (K002737) | Gyrus Ent LLC | 2000-10-12 |
| NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER (K002133) | Boston Scientific Corp | 2000-10-12 |
| SOMATOM EMOTION MS (K003014) | Siemens Medical Solutions USA, Inc. | 2000-10-12 |
| VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR (K002745) | Arista Latindo Industrial Ltd. P.T | 2000-10-12 |
| CARRIAZO BARRAQUER II MICROKERATOME (K002191) | Moria, Inc. | 2000-10-12 |
| DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM (K002143) | Guidant Corp. | 2000-10-12 |
| EZ-COMFORT TRANSPORTER 2000 SERIES (K002673) | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | 2000-10-11 |
| VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 (K002881) | Pulmonetic Systems, Inc. | 2000-10-11 |
| MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 (K002690) | Nonin Medical, Inc. | 2000-10-11 |
| JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM (K002876) | Suiter Medical LLC | 2000-10-11 |
| SURGI-VISION URETHRAL COIL (K002345) | Surgi-Vision, Inc. | 2000-10-11 |
| EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR (K002670) | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | 2000-10-11 |
| NARKOMAT, MODEL 2000 (K000995) | Heyer America, Inc. | 2000-10-11 |
| EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR (K002669) | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | 2000-10-11 |
| PINS AND WIRES (K002125) | Implant Resource, Inc. | 2000-10-11 |
| MAGNETOM ALLEGRA SYSTEM (K002179) | Siemens Medical Solutions USA, Inc. | 2000-10-11 |
| EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL (K002551) | Dade Behring, Inc. | 2000-10-11 |
| IRV2000 INDIVIDUAL RECREATIONAL VEHICLE (K001835) | Trac About, Inc. | 2000-10-11 |
| EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL (K002974) | Dade Behring, Inc. | 2000-10-11 |
| COMPOSIX E/X MESH (K002684) | C.R. Bard, Inc. | 2000-10-11 |
| VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR (K002746) | Arista Latindo Industrial Ltd. P.T | 2000-10-11 |
| TITANIUM MIDDLE EAR PROSTHESES (K002897) | Xomed, Inc. | 2000-10-11 |
| EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR (K002671) | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | 2000-10-11 |
| C.T.M. POWER CHAIR, MODEL HS-5600 (K002983) | Warepalmy Enterprise, LLC (Usa) | 2000-10-11 |
| UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES (K002318) | United Chair Mfg., LLC | 2000-10-11 |
| TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION (K002152) | KLS-Martin L.P. | 2000-10-10 |
| Q-LUX PLASMA 100 LIGHT CURE UNIT (K001719) | Rolence Enterprise Co. , Ltd. | 2000-10-10 |
| COMBINED PHYSIOLOGICAL MONITORING SYSTEM (K002104) | Maryrose Cusimano, Ph.D. & Scott Zeff | 2000-10-10 |
| MODEL 4810 ANALYZER OUTPUT ADAPTER (K002497) | Pace Medical | 2000-10-10 |
| MENICON PROGENT REMOVER (K002140) | Menicon Co, Ltd. | 2000-10-10 |
| MODEL 4815 ADAPTER (K002496) | Pace Medical | 2000-10-10 |
| ATOM INFA WARMER V-505 (K002355) | Atom Medical Corp | 2000-10-10 |
| ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 (K000927) | Misonix, Inc. | 2000-10-10 |
| LIGTHSPEED 3.0 CT SCANNER SYSTEM (K002978) | GE Medical Systems | 2000-10-10 |
| SPEEDLINK TRANSVERSE CONNECTOR (K002082) | Spinal Concepts, Inc. | 2000-10-06 |
| SPL CRIMP SYSTEM (K002110) | Pioneer Surgical Technology | 2000-10-06 |
| MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER (K002939) | Masimo Corp. | 2000-10-06 |
| SYNTHES PROXIMAL HUMERAL NAIL (K002729) | Synthes (Usa) | 2000-10-06 |
| ACTICOAT 7 DRESSING (K001519) | Westaim Biomedical, Inc. | 2000-10-06 |
| RESUSCI INFLATE-A-SHIELD CPR BARRIER (K001742) | Laerdal Medical Corp. | 2000-10-06 |
| EEG SPIKE AND EVENT DETECTOR MODULE (K002332) | Excel Tech. , Ltd. | 2000-10-06 |
| BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE (K002094) | C.R. Bard, Inc. | 2000-10-06 |
| SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) (K002557) | Axya Medical, Inc. | 2000-10-06 |
| TUTOPATCH (K991296) | Tutogen Medical U.S., Inc. | 2000-10-06 |
| ADVANTAGE DRIVE SYSTEM (K002523) | Linvatec Corp. | 2000-10-06 |
| BIOMET BI-POLAR SHOULDER SYSTEM (K002998) | Biomet, Inc. | 2000-10-06 |
| INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM (K002592) | Interpore Cross Intl. | 2000-10-06 |
| PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X (K002228) | Paradigm Medical Industries, Inc. | 2000-10-06 |
| VACUETTE WITH PPACK (K002777) | Greiner Vacuette North America, Inc. | 2000-10-05 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K002751) | Masimo Corp. | 2000-10-05 |
| ELECSYS DHEA-S CALSET (K002760) | Roche Diagnostics Corp. | 2000-10-05 |
| REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) (K001603) | Repromedix Corp. | 2000-10-05 |
| RANDOX MICROALBUMIN (K002674) | Randox Laboratories, Ltd. | 2000-10-05 |
| S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08 (K002478) | Datex-Ohmeda, Inc. | 2000-10-05 |
| ELS CANNULA (KIT), MODEL M1210-88,M1510-88 (K002857) | Jostra AG | 2000-10-05 |
| CATHCOR DESKTOP (K002137) | Siemens Elema AB | 2000-10-05 |
| ASCEND SPINAL FIXATION SYSTEM (K002069) | Spinal Innovations, LLC | 2000-10-05 |
| PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 (K002799) | Beckman Coulter, Inc. | 2000-10-05 |
| I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 (K001387) | I-Stat Corp. | 2000-10-05 |
| SPIROL EPIDURAL CATHETER (K000886) | Abbott Laboratories | 2000-10-05 |
| REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) (K001606) | Repromedix Corp. | 2000-10-05 |
| REFACTO LABORATORY STANDARD (K002350) | The Genetics Institute | 2000-10-05 |
| N PROTEIN STANDARD SL (K002804) | Dade Behring, Inc. | 2000-10-05 |
| REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (K001607) | Repromedix Corp. | 2000-10-05 |
| XIA SPINE SYSTEM (K002505) | Howmedica Osteonics Corp. | 2000-10-05 |
| TDK HANDPIECES (K000848) | Orasystems | 2000-10-05 |
| RAPID EXCHANGE TAPERTOME (K002802) | Boston Scientific Corp | 2000-10-05 |
| MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM (K002879) | Bioplate, Inc. | 2000-10-05 |
| MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR (K002850) | Narishige Co., Ltd. | 2000-10-05 |
| BROOKER TIBIA NAILS (K002057) | Biomet Orthopedics, Inc. | 2000-10-04 |