| SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20 (K992424) | Plastimed Laboratoire Pharmaceutique | 2000-12-29 |
| BIOMET EXTERNAL WRIST PLATE (K003240) | Biomet, Inc. | 2000-12-29 |
| INJECTRITE-C15 AND INJECTRITE-C30 (K002127) | Sterling Medivations, Inc. | 2000-12-29 |
| AVITA TSO/TS1 INFRARED EAR THERMOMETER (K002182) | Avita Corporation | 2000-12-29 |
| FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) (K003212) | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-28 |
| BRAIN COIL, MODEL 9800GE-64 (K003097) | Midwest Rf, LLC | 2000-12-28 |
| INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K003040) | Intratherapeutics, Inc. | 2000-12-28 |
| EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY (K001576) | Prosurg, Inc. | 2000-12-28 |
| SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64 (K003386) | Midwest Rf, LLC | 2000-12-28 |
| PHORMAX EAGLE SCANNER SYSTEM (K001499) | Phormax Corp. | 2000-12-27 |
| COMPUMEDICS SIESTA SYSTEM (K003175) | Compumedics Limited | 2000-12-27 |
| TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER (K003815) | Merits Health Products., Inc. | 2000-12-27 |
| THE O'NEIL STERILE FIELD URINARY CATHETER KIT (K002803) | Go Medical Industries Pty. , Ltd. | 2000-12-27 |
| DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT (K001738) | DePuy Orthopaedics, Inc. | 2000-12-27 |
| SURGISIS PERIPHERAL VASCULAR PATCH (K001785) | Cook Biotech, Inc. | 2000-12-27 |
| GYROSCAN INTERA 3.0T (K003516) | Philips Medical Systems North America, Inc. | 2000-12-27 |
| XISCAN 6000 IMAGING SYSTEM (K003568) | Xitec, Inc. | 2000-12-27 |
| PHACOFRAGMENTATION SYSTEM MEGATRON (K002031) | Asclepion-Meditec AG | 2000-12-27 |
| NUMED Z-MED PTV CATHERERS (K003643) | NuMED, Inc. | 2000-12-27 |
| ALOKA SSD-4000 (K003739) | Aloka Co., Ltd. | 2000-12-27 |
| PELVIC MUSCLE THERAPY (K002830) | Colonial Medical Supply | 2000-12-27 |
| MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) (K003215) | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-27 |
| CARTOUCH (K002197) | Cardionics, Inc. | 2000-12-27 |
| V SCORE WITH AUTO GATE MODEL TBD (K003230) | Vital Images, Inc. | 2000-12-27 |
| APNOESCREEN PRO, ALPHA SCREEN PRO (K000396) | Erich Jaeger, Inc. | 2000-12-27 |
| IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP (K003372) | Diagnostic Products Corp. | 2000-12-26 |
| ABX PENTRA 60C+ HEMATOLOGY ANALYZER (K003677) | Abx Diagnostics | 2000-12-26 |
| CRYOSURGICAL UNIT AND ACCESSORIES (K003050) | Cryogen, Inc. | 2000-12-26 |
| BIOTEQ I.V. (INTRAVENOUS) SET (K002449) | Bioteque Corp. | 2000-12-22 |
| CD HORIZON SPINAL SYSTEM (K000641) | Medtronic Sofamor Danek, Inc. | 2000-12-22 |
| DW 276 #3 (K003635) | Ivoclar North America, Inc. | 2000-12-22 |
| EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION (K003257) | Cybercare Technologies, Inc. | 2000-12-22 |
| RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX (K002976) | St Jude Medical | 2000-12-22 |
| PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 (K003270) | Nucletron Corp. | 2000-12-22 |
| VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC (K003687) | Medtox Diagnostics, Inc. | 2000-12-22 |
| PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) (K994279) | Pure Water Solutions, Inc. | 2000-12-22 |
| PEDIATRIC INGESTASCAN (K003305) | Adams Electronics, Inc. | 2000-12-22 |
| FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING (K003134) | Adri/Technam | 2000-12-22 |
| MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL (K003685) | Medical Advances, Inc. | 2000-12-22 |
| ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 (K003769) | Ansell Healthcare Products, Inc. | 2000-12-22 |
| SYNCHRON SYSTEMS AMMONIA REAGENT (K003196) | Beckman Coulter, Inc. | 2000-12-22 |
| GE ADVANCE NXI PET SYSTEM (K003849) | Ge Medical Systems, Inc. | 2000-12-22 |
| TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 (K003036) | Retinalabs.Com | 2000-12-22 |
| DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 (K003790) | Davol, Inc. | 2000-12-22 |
| CLEANAIR/ CLEANWATER UNIT, MODEL 1600 (K003265) | Texas Institute For Conservative Dentistry | 2000-12-22 |
| MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL (K003366) | Igc-Medical Advances, Inc. | 2000-12-22 |
| AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 (K001955) | Aaron Medical Industries | 2000-12-22 |
| SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL (K003243) | Siemens Medical Solutions USA, Inc. | 2000-12-21 |
| CAPNO PROBE A (K984579) | Optical Sensors, Inc. | 2000-12-21 |
| QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION (K003264) | Ge Medical Systems F.I. Haifa | 2000-12-21 |
| MEDIADENT HDX/MMD HDX SP XRAY SENSOR (K002425) | Multi Media Dental Systems, Inc. | 2000-12-21 |
| EMPIRE N BLOOD PRESSURE MANOMETERS (K002955) | Rudolf Riester GmbH & Co. KG | 2000-12-21 |
| MSD EMBOLECTOMY BASKET (K991093) | Metamorphic Surgical Devices, LLC | 2000-12-21 |
| VECTOR (K002122) | Air Techniques, Inc. | 2000-12-21 |
| INTERACTIVE REAL TIME SCANNING PACKAGE (K003623) | Siemens Medical Solutions USA, Inc. | 2000-12-21 |
| CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 (K001634) | Tz Medical, Inc. | 2000-12-21 |
| MAGNETIC CONCERTO (K003192) | Siemens Medical Solutions USA, Inc. | 2000-12-21 |
| RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS (K002954) | Rudolf Riester GmbH & Co. KG | 2000-12-21 |
| SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER (K003248) | Siemens Medical Solutions USA, Inc. | 2000-12-21 |
| SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33 (K003277) | Powermed, Inc. | 2000-12-21 |
| PUMP TUBING WITH X-COATING (K003371) | Terumo Corp. | 2000-12-21 |
| DW 272 #1 (K003634) | Ivoclar North America, Inc. | 2000-12-21 |
| VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET (K000714) | Med-Pro Technologies, Inc. | 2000-12-21 |
| NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K003547) | Terang Nusa Sdn Bhd | 2000-12-21 |
| DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 (K003598) | Datascope Corp. | 2000-12-21 |
| CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B (K003724) | Medtronic Vascular | 2000-12-21 |
| SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION (K003246) | Siemens Medical Solutions USA, Inc. | 2000-12-21 |
| HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 (K003337) | Weck Closure Systems | 2000-12-21 |
| NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE (K003545) | Terang Nusa Sdn Bhd | 2000-12-21 |
| BIO-LOGIC SLEEPSCAN NETLINK (K003681) | Bio-Logic Systems Corp. | 2000-12-21 |
| SERUM PROTEIN SUBSTITUTE (K003734) | Sage Biopharma | 2000-12-21 |
| CHEMO-AIDE DISPENSING PIN (K003730) | Baxter Healthcare Corp | 2000-12-20 |
| REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702 (K003624) | Arthrocare Corp. | 2000-12-20 |
| COOLTOUCH VARIA-II ND:YAG LASER SYSTEM (K003781) | Cooltouch Corp. | 2000-12-20 |
| COOLBLU CURING LIGHT (K002925) | Dental Systems.Com, Inc. | 2000-12-20 |
| CRIT-LINE MONITOR III (CLM III) (K001763) | In-Line Diagnostics Corp. | 2000-12-20 |
| CONFORMANCE CHEMISTRY CONTROL C3 (K003716) | Consolidated Technology | 2000-12-20 |
| RDH BANDAGE (K002550) | Marine Polymer Technologies, Inc. | 2000-12-20 |
| OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A (K002308) | Trimedyne, Inc. | 2000-12-20 |
| ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 (K003621) | Agilent Technologies, Inc. | 2000-12-20 |
| ELECSYS DHEA-S CALCHECK (K003772) | Roche Diagnostics Corp. | 2000-12-20 |
| DW 273 #1 (K003632) | Ivoclar North America, Inc. | 2000-12-20 |
| PLACEMENT-PLUS (K003642) | Catheter Innovations, Inc. | 2000-12-20 |
| WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM (K003100) | Boston Scientific Corp | 2000-12-20 |
| HAKIM PROGRAMMER AND TRANSMITTER (K003564) | Codman & Shurtleff, Inc. | 2000-12-20 |
| Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 (K003118) | Zcv ,Inc. | 2000-12-20 |
| GOLD CORE POST SOLDER (K002854) | Jeneric/Pentron, Inc. | 2000-12-20 |
| DW 277 #4 (K003633) | Ivoclar North America, Inc. | 2000-12-20 |
| HEARTSTREAM FR2 AED, MODEL M3860A,M3861A (K003565) | Agilent Technologies, Inc. | 2000-12-20 |
| MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM (K003728) | Tornier | 2000-12-20 |
| PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING (K002942) | Philips Medical Systems North America, Inc. | 2000-12-19 |
| VARIANT II TOTAL GHB (K003280) | Bio-Rad | 2000-12-19 |
| NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM (K002393) | Innolatex Sdn. Bhd | 2000-12-19 |
| APPRAISE URINE MICROALBUMIN COLLECTION KIT (K002156) | Osborn Group, Inc. | 2000-12-19 |
| BIOMOL ASPIRATION BIOPSY NEEDLE (K002947) | H.S. Hospital Service S.R.L. | 2000-12-19 |
| SILENT BIOPSY NEEDLE (K002946) | H.S. Hospital Service S.R.L. | 2000-12-19 |
| BAYER RAPIDPOINT 400 SYSTEM (K002738) | Bayer Corp. | 2000-12-19 |
| MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM (K000081) | Isotopes and Metals , Ltd. | 2000-12-19 |
| GOLD CORE HF PRE SOLDER (K002815) | Jeneric/Pentron, Inc. | 2000-12-19 |
| NEURO II (K002964) | Innovative Magnetic Resonance Imaging Systems, Inc. | 2000-12-19 |