| DISCOVERY ELBOW (K013042) | Biomet Orthopedics, Inc. | 2001-10-10 |
| WIENER LAB. CREATININA CINETICA AA (K012065) | Wiener Laboratories Saic | 2001-10-10 |
| CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 (K010954) | Concentric Medical, Inc. | 2001-10-09 |
| PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM (K012509) | Phoenix Diagnostics, Inc. | 2001-10-09 |
| CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE (K012886) | Cbyon, Inc. | 2001-10-09 |
| SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 (K013029) | St Jude Medical | 2001-10-09 |
| AUTO-LOCK (K010477) | Auto-Lock | 2001-10-09 |
| MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST (K991810) | Trek Diagnostic Systems, Inc. | 2001-10-09 |
| LASER 20 (K011021) | Ya-Man, Ltd. | 2001-10-09 |
| PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (K012427) | Specialites Septodont | 2001-10-09 |
| PHEM-ALERT (K012230) | Femtek,Llc. | 2001-10-09 |
| MONARCH SPINAL SYSTEMS (K013294) | Depuyacromed | 2001-10-09 |
| TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 (K012518) | Thermo Dma, Inc. | 2001-10-09 |
| MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER (K010016) | Cook, Inc. | 2001-10-09 |
| ABI VEST AIRWAY CLEARANCE SYSTEM (K012928) | Advanced Respiratory | 2001-10-09 |
| MOSS MIAMI SPINAL SYSTEMS (K013296) | Depuyacromed | 2001-10-09 |
| TIMX SPINAL SYSTEMS (K013295) | Depuyacromed | 2001-10-09 |
| MU PHOTONICS PAIN THERAPIST (K012508) | Nu Photonics, Inc. | 2001-10-09 |
| ANIMEC, MODELS AM-2S-4 AND AM-2S-5 (K012906) | Elltec Co., Ltd. | 2001-10-09 |
| VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D (K012367) | Nichols Institute Diagnostics | 2001-10-09 |
| MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE (K012485) | King Systems Corp. | 2001-10-09 |
| THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER (K010706) | Measurement Specialties, Inc. | 2001-10-05 |
| CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A (K013214) | Toshiba America Medical Systems, In.C | 2001-10-05 |
| ZEUS ROBOTIC SURGICAL SYSTEM (K003431) | Computer Motion, Inc. | 2001-10-05 |
| DIASUS (K013142) | Dynamic Imaging , Ltd. | 2001-10-05 |
| ALWAYS DUETS (K012629) | Procter & Gamble Co. | 2001-10-05 |
| COM-PATCH (K012140) | Apex Medical Corp. | 2001-10-05 |
| SOCRATES ROBOTIC TELEMONITORING SYSTEM (K003661) | Computer Motion, Inc. | 2001-10-05 |
| W & H ASSISTINA (K010127) | A-Dec, Inc. | 2001-10-05 |
| MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K012993) | Cordis Corp. | 2001-10-05 |
| SOPRO595 INTRA ORAL CAMERA (K012505) | Sopro | 2001-10-05 |
| ISOLA SPINAL SYSTEMS (K012971) | Depuyacromed | 2001-10-05 |
| INION CPS 2.0 ORTHOGNATHIC PLATE (K013039) | Inion , Ltd. | 2001-10-05 |
| INTERCOSTAL LOCKABLE-DIRECTABLE PORT (K011349) | Medcanica, Inc. | 2001-10-05 |
| AL-40 (K010715) | Ddc Technologies, Inc. | 2001-10-04 |
| BLOCK CEMENT RESTRICTOR (CR) - TITANIUM (K013014) | Medtronic Sofamor Danek, Inc. | 2001-10-04 |
| MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM (K012950) | Medrad, Inc. | 2001-10-04 |
| PULSEMASTER ERBIUM DENTAL LASER SYSTEM (K012127) | American Dental Technologies, Inc. | 2001-10-04 |
| ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 (K012923) | Arthrex, Inc. | 2001-10-04 |
| URETEX SUP PUBOURETHRAL SLING (K012949) | Sofradim Production | 2001-10-04 |
| END EXPIRATORY FILTER, MODEL RT020 (K002839) | Fisher & Paykel Healthcare, Ltd. | 2001-10-04 |
| MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS (K010804) | Biolitec, Inc. | 2001-10-04 |
| MODIFICATION TO: THERMACOOL IIA (K013034) | Thermage, Inc. | 2001-10-04 |
| C. NET 2100 (K010396) | Cardionetics, Ltd. | 2001-10-04 |
| THE QUIET SLEEPER (K012142) | Precision Dental Laboratories, Inc. | 2001-10-04 |
| DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (K012235) | Denver Biomedical, Inc. | 2001-10-04 |
| DISPOSABLE POWDERED VINYL EXAMINATION GLOVES (K012710) | Shijiazhuang Brilliance Plastic Co., Ltd. | 2001-10-04 |
| MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM (K012967) | Disco-O-Tech Medical Technologies, Ltd. | 2001-10-04 |
| THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 (K012525) | Thermo Dma, Inc. | 2001-10-04 |
| MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR (K004001) | Dideco | 2001-10-04 |
| EASYTRAVEL (K012592) | Tzora Active Systems , Ltd. | 2001-10-03 |
| MEDCOMP EXCELL SPLIT TIP CATHETER (K010306) | Medcomp | 2001-10-03 |
| TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 (K012999) | Biosite Incorporated | 2001-10-03 |
| BIPOLAR IRRIGATION FORCEPS (K012986) | Aesculap, Inc. | 2001-10-03 |
| THE SALICEPT ORAL PATCH (K012126) | Carrington Laboratories, Inc. | 2001-10-03 |
| HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 (K994105) | Medical Components, Inc. | 2001-10-03 |
| MODIFICATION TO VAXCEL DIALYSIS CATHETER (K012948) | Boston Scientific/Medi-Tech | 2001-10-03 |
| ATAC PAK CPK REAGENT KIT (K012474) | Elan Holdings, Inc. | 2001-10-03 |
| PRO-FEMUR (K012091) | Wrightmedicaltechnologyinc | 2001-10-03 |
| BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 (K013009) | Sybron Dental Specialties, Inc. | 2001-10-03 |
| OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI (K012446) | Charles A. Smith | 2001-10-03 |
| NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR (K012345) | Bromac Assistive Technology | 2001-10-03 |
| TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 (K013002) | Biosite Incorporated | 2001-10-03 |
| MODIFICATION TO FLOUROLAB PLUS (K013025) | Z-Kat, Inc. | 2001-10-03 |
| MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES (K012992) | Masimo Corp. | 2001-10-03 |
| MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 (K012336) | Medical Data Electronics | 2001-10-03 |
| NEXUS 2 MODIFIED (K013008) | Sybron Dental Specialties, Inc. | 2001-10-02 |
| SMARTFLOW (K012947) | Florence Medical , Ltd. | 2001-10-02 |
| GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C (K012383) | Alaris Medical Systems, Inc. | 2001-10-02 |
| HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT (K012952) | Boston Scientific/Medi-Tech | 2001-10-02 |
| SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE (K013104) | Sterling Medivations, Inc. | 2001-10-02 |
| COOLTOUCH VARIZOOM (K012982) | New Star Lasers, Inc. | 2001-10-02 |
| SUNLITELED MODEL #2810 (K012946) | Kinetic Instruments, Inc. | 2001-10-02 |
| ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 (K012435) | Bausch & Lomb, Inc. | 2001-10-02 |
| MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 (K012227) | Oncology Data Systems, Inc. | 2001-10-01 |
| CYTOFLEX (K012144) | Unicare Biomedical, Inc. | 2001-10-01 |
| SOLID STATE X-RAY IMAGING DEVICES (K003238) | Cares Built, Inc. | 2001-10-01 |
| NAVIGUS II TRAJECTORY GUIDE (K012366) | Image-Guided Neurologics, Inc. | 2001-10-01 |
| CTS-485 ULTRASOUND IMAGING SYSTEM (K012772) | Shantou Institute of Ultrasonic Instuments | 2001-10-01 |
| CODMAN BACTISEAL CATHETERS (K003322) | Codman & Shurtleff, Inc. | 2001-10-01 |
| BIS/EEG MODULE (K012466) | General Electric Medical Systems Information Techn | 2001-10-01 |
| XLTEK LED GOGGLES, MODEL LED-01 (K011794) | Excel Tech. , Ltd. | 2001-10-01 |
| SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE (K012283) | Safegard Medical Products, Inc. | 2001-10-01 |
| ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 (K012176) | Ethicon Endo-Surgery, Inc. | 2001-10-01 |
| SONICWAVE SONIC PLAQUE REMOVER (K012914) | Homedics, Inc. | 2001-10-01 |
| EXPRESSSUITE (K011049) | Vidar Systems Corp. | 2001-10-01 |
| DOSERIGHT (K012238) | Philips Medical Systems North America Co. | 2001-10-01 |
| DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K012876) | Wrp Specialty Products Sdn. Bhd. | 2001-10-01 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN) (K012709) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2001-10-01 |
| BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) (K012340) | Bayer Corp. | 2001-10-01 |
| EXHALE PROBE (K013111) | Broncus Technologies, Inc. | 2001-10-01 |
| POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) (K012786) | Shamrock Manufacturing Company | 2001-10-01 |
| BELLEGLASS HP ENAMEL 2 (K013007) | Sybron Dental Specialties, Inc. | 2001-10-01 |
| DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM (K012081) | Medtronic Sofamor Danek, Inc. | 2001-10-01 |
| BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS (K012335) | Albert Browne , Ltd. | 2001-10-01 |
| PLATELETWORKS (K012723) | Helena Laboratories | 2001-09-28 |
| BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER (K012913) | C.R. Bard, Inc. | 2001-09-28 |
| UCLA AND UNIVERSAL ABUTMENTS (K010619) | Diamodent | 2001-09-28 |
| REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT (K013080) | Corgenix, Inc. | 2001-09-28 |
| REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT (K013079) | Corgenix, Inc. | 2001-09-28 |