| ROK (K012529) | Southern Dental Industries, Ltd. | 2001-10-22 |
| NAVIGUS II MR (K012719) | Image-Guided Neurologics, Inc. | 2001-10-22 |
| BIOSCANNER PLUS; LIPID PANEL TEST STRIPS (K013173) | Polymer Technology Systems, Inc. | 2001-10-22 |
| MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM (K013156) | Data Critical Corp. | 2001-10-19 |
| MARK II/MARK III MANOMETRIC PERFUSION PUMP (K013154) | Dentsleeve Pty., Ltd. | 2001-10-19 |
| IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) (K013135) | Diagnostic Products Corp. | 2001-10-19 |
| TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE (K013016) | Tillotson Healthcare Corp. | 2001-10-19 |
| MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM (K012510) | Nxstage Medical, Inc. | 2001-10-19 |
| WILSON-COOK ULTRASOUND BIOPSY NEEDLE (K013356) | Wilson-Cook Medical, Inc. | 2001-10-19 |
| 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH (K013162) | Medcomp | 2001-10-19 |
| POWERPRO BATTERY SYSTEM (K012320) | Linvatec Corp. | 2001-10-19 |
| ASTRALIS 10, MODELS # 559588, 561859 (K013275) | Ivoclar Vivadent, Inc. | 2001-10-19 |
| DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W (K013144) | C.R. Bard, Inc. | 2001-10-19 |
| AUTOTOME RX MODEL # 4515, 4516 (K013153) | Boston Scientific Corp | 2001-10-19 |
| AML HIP PROSTHESIS (K012364) | DePuy Orthopaedics, Inc. | 2001-10-19 |
| RIWO SYSTEM TRAYS (K012309) | Richard Wolf Medical Instruments Corp. | 2001-10-19 |
| ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS (K002132) | Intelligent Instruments Pvt. , Ltd. | 2001-10-18 |
| SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM (K012424) | Shimadzu Corp. | 2001-10-18 |
| LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS (K012409) | Walter Lorenz Surgical, Inc. | 2001-10-18 |
| STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES (K003857) | Sterilmed, Inc. | 2001-10-18 |
| N LP(A) CONTROL SY (K013130) | Dade Behring, Inc. | 2001-10-18 |
| PROSAFE SAFETY SYRINGE (K012726) | Hou-Se Medical, Inc. | 2001-10-18 |
| WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL (K012522) | National Therapy Products, Inc. | 2001-10-18 |
| MOSFET AUTOSENSE, MODEL TN-RD-60 (K013279) | Thomson & Nielsen Electronics, Ltd. | 2001-10-18 |
| MR-GUIDE 2000 (K013150) | Ultraguide , Ltd. | 2001-10-18 |
| SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM (K012961) | Sulzer Orthopedics, Inc. | 2001-10-18 |
| SEED SELECTRON MODEL V. 1.0 (K010032) | Nucletron Corp. | 2001-10-17 |
| LUXABITE (K013236) | Dmg USA, Inc. | 2001-10-17 |
| METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (K012265) | Circon Video | 2001-10-17 |
| SONICATOR PLUS 930, MODEL ME 930 (K013192) | Mettler Electronics Corp. | 2001-10-17 |
| HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE (K011247) | Acusupply, Inc. | 2001-10-17 |
| VANGUARD REPROCESSED COMPRESSION GARMENT (K012403) | Vanguard Medical Concepts, Inc. | 2001-10-17 |
| FLEXI-SITE SP02 EAR SENSOR (K012333) | Epic Medical Equipment Services, Inc. | 2001-10-17 |
| THEKEN SMALL CEMENT RESTRICTOR (K012278) | Theken Surgical,Llc | 2001-10-17 |
| STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION (K012482) | KARL STORZ Endoscopy-America, Inc. | 2001-10-16 |
| REVOTEK LC (K012542) | GC America, Inc. | 2001-10-16 |
| ACCESS UNCONJUGATED ESTRIOL CALIBRATORS (K012900) | Beckman Coulter, Inc. | 2001-10-16 |
| MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (K013215) | Nuvasive, Inc. | 2001-10-16 |
| POLY STAT HCG TEST (K012559) | Bion Diagnostic Sciences | 2001-10-16 |
| ALGO 3 NEWBORN HEARING SCREENER (K013137) | Natus Medical, Inc. | 2001-10-16 |
| VERTRAN STANDING WHEELCHAIR (K011530) | Fena Design, Inc. | 2001-10-16 |
| MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE (K013176) | Afp Imaging Corp. | 2001-10-16 |
| HAC-420 HEAD ARRAY COIL (K013322) | Mri Devices Corp. | 2001-10-16 |
| ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES (K012499) | Shanghai Antares Industries, Inc. | 2001-10-16 |
| VANGUARD REPROCESSED ARTHROSCOPIC BLADES (K012346) | Vanguard Medical Concepts, Inc. | 2001-10-16 |
| ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) (K011337) | Accumetrics, Inc. | 2001-10-16 |
| ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW (K012339) | Shanghai Antares Industries, Inc. | 2001-10-16 |
| HRH-63-8 HEAD ARRAY COIL (K013159) | Mri Devices Corp. | 2001-10-16 |
| MODIFICATION TO SYNCHRON CONTROL (K013235) | Beckman Coulter, Inc. | 2001-10-16 |
| THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 (K012878) | Thermo Dma, Inc. | 2001-10-16 |
| VBR (K012254) | Osteotech, Inc. | 2001-10-16 |
| RAICHEM GLUCOSE UV REAGENT (K012668) | Hemagen Diagnostics, Inc. | 2001-10-15 |
| MERTEX-PLUS REUSABLE SURGICAL DRAPE (K012237) | Mercan AB | 2001-10-15 |
| MT ALERT INFUSION MONITOR (K013121) | Sierra Biosearch, Inc. | 2001-10-15 |
| CHIBA NEEDLE (K012358) | Ispg, Inc. | 2001-10-15 |
| FAS ENDOLUMINAL BRUSH (K012641) | Fas Medical , Ltd. | 2001-10-15 |
| IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) (K013134) | Diagnostic Products Corp. | 2001-10-15 |
| ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE (K012595) | ACON Laboratories, Inc. | 2001-10-15 |
| MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE (K011283) | The Kendall Company | 2001-10-15 |
| SURSHIELD SAFETY WINGED BLOOD COLLECTION SET (K013164) | Terumo Medical Corp. | 2001-10-15 |
| EAR MUFFINS (K012384) | Bio-Logic Systems Corp. | 2001-10-15 |
| RAICHEM BUN RATE REAGENT (K012649) | Hemagen Diagnostics, Inc. | 2001-10-15 |
| PAM-RL (K010997) | Individual Monitoring Systems, Inc. | 2001-10-15 |
| POWDERED LATEX EXAMINATION GLOVES (K013026) | Great Glove (Thailand) Co. , Ltd. | 2001-10-15 |
| TORAYSULFONE DIALYZER (K002512) | Toray Industries (America), Inc. | 2001-10-15 |
| MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE (K012240) | Mercan AB | 2001-10-15 |
| MODIFICATION TO ALPHA DX SYSTEM (K013118) | First Medical, Inc. | 2001-10-15 |
| MAGELLAN-2200, MODEL 1 (K010613) | Oceanic Medical Products, Inc. | 2001-10-12 |
| MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) (K004005) | Mentor Corp. | 2001-10-12 |
| LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (K012218) | The Ludlow Company LP | 2001-10-12 |
| K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (K012404) | Katecho, Inc. | 2001-10-12 |
| SDI SB OFFICE, MODEL 29- (K011470) | Sdi Diagnostics, Inc. | 2001-10-12 |
| LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE (K013229) | Ferrania USA, Inc. | 2001-10-12 |
| ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM (K012206) | Cambridge Heart, Inc. | 2001-10-12 |
| BIOMEDICS UV MULTIFOCAL (K012425) | Ocular Sciences Puerto Rico, Inc. | 2001-10-12 |
| CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA (K013286) | Tillotson Healthcare Corp. | 2001-10-12 |
| CYCLOTEC AMT CTI TENS DEVICE (K010615) | Cyclotec | 2001-10-12 |
| LUXAGLAZE (K013179) | Dmg USA, Inc. | 2001-10-12 |
| INSTRUMENT DAMPING PORT (K011373) | Medcanica, Inc. | 2001-10-12 |
| BIOCUFF,C, MODELS 236018, 236028, 236036 (K013057) | Bionx Implants, Inc. | 2001-10-12 |
| OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM (K012402) | Omnigrace (Thailand) , Ltd. | 2001-10-12 |
| ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM (K012883) | Boston Scientific Corp | 2001-10-12 |
| MODIFICATION TO: COMPEL SURGICAL DRAPES (K012807) | Standard Textile Co., Inc. | 2001-10-11 |
| LEVEEN ELECTRODE (K012315) | Radiotherapeutics Corp. | 2001-10-11 |
| THECURVE, ITEM 507 (K012935) | Select Medical Systems, Inc. | 2001-10-11 |
| CANDELA CLEARBEAM PULSED DYE LASER (K013043) | Candela Corp. | 2001-10-11 |
| BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM (K011080) | Medtronic Ave, Inc. | 2001-10-11 |
| CRYOCARE SURGICAL SYSTEM (K003811) | Endocare, Inc. | 2001-10-11 |
| EPOCA CUSTOM OFFSET SHOULDER SYSTEM (K010869) | Argomedical AG | 2001-10-11 |
| RHODIA DENTAL PUTTY IMPRESSION MATERIAL (K013129) | Rhodia, Inc. | 2001-10-10 |
| HELIX HYDRO-JET (K012464) | Andreas Pein Medizintechnik GmbH | 2001-10-10 |
| GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L (K010985) | Gambro Renal Products | 2001-10-10 |
| MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC (K012264) | National Custom Ent., Inc. | 2001-10-10 |
| MODIFICATION TO A620 EEG (K012011) | Stoelting Co. | 2001-10-10 |
| MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 (K012263) | National Custom Ent., Inc. | 2001-10-10 |
| SNOWPOST, SNOWLIGHT (K012354) | Danville Materials, Inc. | 2001-10-10 |
| RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL (K013140) | Rhodia, Inc. | 2001-10-10 |
| DURACON PS LIPPED TIBIAL INSERT (K012172) | Howmedica Osteonics | 2001-10-10 |
| TITANIUM CEMENT RESTRICTOR MATERIAL PEEK (K010528) | Medtronic Sofamor Danek USA, Inc. | 2001-10-10 |
| UNIMARK HCG COMBO PREGNANCY TEST (K013194) | Biotech Atlantic, Inc. | 2001-10-10 |