| ANS AXXESS PERCUTANEOUS LEAD (K032034) | Advanced Neuromodulation Systems | 2003-10-03 |
| GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 (K032085) | Nidek, Inc. | 2003-10-03 |
| SONOSURG SYSTEM (K032066) | The Olympus Optical Co. | 2003-10-03 |
| ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH (K032200) | Remco Italia S.P.A. | 2003-10-03 |
| REPROCESSED ELECTROPHYSIOLOGY CATHETER (K030279) | Alliance Medical Corp. | 2003-10-03 |
| 3D INVIVO BY CSIST (K031567) | Chung-Shan Institute of Science and Technology | 2003-10-02 |
| ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) (K031439) | Harry J. Bosworth Co. | 2003-10-02 |
| MICROMLC (K032790) | Siemens Medical Solutions USA, Inc. | 2003-10-02 |
| GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I (K032177) | Olympus Opto-Electronics Co., Ltd. | 2003-10-02 |
| CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA (K032737) | Cordis Europa, N.V. | 2003-10-02 |
| OPTICAL SEPARATOR (K032889) | Applied Medical Resources | 2003-10-02 |
| MINICAT DENTOCAT (K032243) | Xoran Technologies, Inc. | 2003-10-02 |
| HLS NOETOS SYSTEM (K032079) | Tornier | 2003-10-02 |
| EDWARDS PERIPHERAL DILATATION CATHETER (K032587) | Edwards Lifesciences, LLC | 2003-10-02 |
| MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE (K032750) | Friandent GmbH | 2003-10-02 |
| ECHOENCODER (K032324) | Icardiogram, Incorporated | 2003-10-02 |
| AQUABOSS ECORO DIA 50 (K032004) | Lauer Ltd., Hong Kong | 2003-10-02 |
| HL888 AF (K032913) | Health & Life Co., Ltd. | 2003-10-02 |
| VAXCEL PLUS CHRONIC DIALYSIS CATHETER (K032712) | Boston Scientific Corp | 2003-10-02 |
| 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM (K032140) | Innova Life Sciences Corp. | 2003-10-02 |
| ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM (K032210) | Alara, Inc. | 2003-10-02 |
| HL888BF (K032695) | Health & Life Co., Ltd. | 2003-10-02 |
| XIVE TG ABUTMENTS (K032302) | Friadent GmbH | 2003-10-02 |
| MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K (K032234) | Mk-Dent GmbH | 2003-10-02 |
| SECTRA ORTHOPEDIC PACKAGE (K031590) | Sectra-Imtec AB | 2003-10-02 |
| I-BEAM (K032100) | Computerized Medical Systems, Inc. | 2003-10-02 |
| IMMIX PLASTIFILM (K032673) | Osteobiologics, Inc. | 2003-10-02 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES (K032616) | Elite International, Inc. | 2003-10-02 |
| THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 (K032344) | Implex Corp. | 2003-10-02 |
| ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER (K024023) | Essex Medical Systems Plus | 2003-10-01 |
| CLS-2000 UNIT (K024133) | Dentsply Intl. | 2003-10-01 |
| BIOSIGN STEAM-24 BIOLOGICAL INDICATOR (K032723) | Getinge USA, Inc. | 2003-10-01 |
| MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K032805) | Vascular Solutions, Inc. | 2003-10-01 |
| CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, (K022505) | NOUVAG AG | 2003-10-01 |
| LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE (K032072) | Arthrotek, Inc. | 2003-10-01 |
| SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER (K031440) | Cynosure, Inc. | 2003-10-01 |
| PERIFIX CATHETER CONNECTOR (K032144) | B.Braun Medical, Inc. | 2003-10-01 |
| CYNOSURE SMART 2940D ER:YAG LASER (K031389) | Cynosure, Inc. | 2003-10-01 |
| DISTAL RADIUS FRACTURE REPAIR SYSTEM (K032705) | Hand Innovations, Inc. | 2003-10-01 |
| TRIGEN STRAIGHT HUMERAL NAIL SYSTEM (K032722) | Smith & Nephew, Inc. | 2003-10-01 |
| APPOLLO 3 ALLOY (K032320) | Dentsply International | 2003-10-01 |
| OLYMPUS ULTRASONIC SURGICAL SYSTEM (K031523) | Aomori Olympus Co., Ltd. | 2003-10-01 |
| W.O.M. LASER U100PLUS (K032023) | W.O.M. World of Medicine AG | 2003-10-01 |
| CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W (K031922) | Merit Medical Systems, Inc. | 2003-10-01 |
| ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM (K032875) | Aloka Co. Ltd USA | 2003-09-30 |
| DURAGEN PLUS DURAL GRAFT MATRIX (K032693) | Integra Lifesciences Corp. | 2003-09-30 |
| U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE (K032247) | U.S. Technologies, Inc. | 2003-09-30 |
| TULIP COLORSWITCH (K032116) | Cavex Holland BV | 2003-09-30 |
| ORION GX ALLOY (K032317) | Dentsply Intl. | 2003-09-30 |
| CERA R PLUS ALLOY (K032319) | Dentsply International | 2003-09-30 |
| VASCUPUNCTURE PICC GUIDEWIRE (K031652) | Neometrics, Inc. | 2003-09-30 |
| MINERVA 58 ALLOY (K032318) | Dentsply International | 2003-09-30 |
| PHEM-ALERT (K032161) | Femtek,Llc. | 2003-09-30 |
| SENOVA(R) BLOOD GLUCOSE MONITOR (K032076) | Chdiagnostics, LLC | 2003-09-30 |
| CERA F ALLOY (K032321) | Dentsply International | 2003-09-30 |
| ORION E ALLOY (K032316) | Dentsply Intl. | 2003-09-30 |
| SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33) (K032701) | Power Medical Interventions, Inc. | 2003-09-30 |
| EXTENDED RANGE HS CRP KIT, CAT NO:9200 (K030044) | Reference Diagnostics, Inc. | 2003-09-30 |
| AML HAIRCHECK-DT (COCAINE) (K023626) | Quest Diagnostics, Inc. | 2003-09-29 |
| KSEA MEDI PACK (K022490) | KARL STORZ Endoscopy-America, Inc. | 2003-09-29 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS (K031031) | Ortho-Clinical Diagnostics, Inc. | 2003-09-29 |
| TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 (K031225) | Gfe Medizintechnik GmbH | 2003-09-29 |
| BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT (K032240) | The Binding Site, Ltd. | 2003-09-29 |
| ENVISION (K032042) | Sybron Dental Specialties, Inc. | 2003-09-29 |
| INTRALASE FS LASER (K031960) | Intra Lase Corp. | 2003-09-29 |
| ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 (K031974) | Asap Endoscopic Products GmbH | 2003-09-29 |
| ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR (K030003) | Elan Diagnostics | 2003-09-29 |
| AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE (K032232) | Hitachi Medical Systems America, Inc. | 2003-09-29 |
| PARAPAC 200D TRANSPORT, MODEL V200D (K030803) | Pneupac , Ltd. | 2003-09-29 |
| DRESSSKIN (K023778) | Tei Biosciences, Inc. | 2003-09-29 |
| TORAYSULFONE DIALYZER, BS-L SERIES (K030050) | Toray Industries (America), Inc. | 2003-09-29 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS (K032275) | Becton, Dickinson & CO | 2003-09-29 |
| DEPUY 1 GENTAMICIN BONE CEMENT (K023103) | DePuy Orthopaedics, Inc. | 2003-09-29 |
| IRRIGATION SETS (K032832) | Vital Concepts, Inc. | 2003-09-26 |
| RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 (K031308) | Rhigene, Inc. | 2003-09-26 |
| RAYCELL (K032684) | Mds Nordion | 2003-09-26 |
| ULTRACROWN 75 ALLOY (K032851) | Dentsply International | 2003-09-26 |
| DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (K032151) | Depuy, Inc. | 2003-09-26 |
| MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM (K032892) | Dentsply Intl. | 2003-09-26 |
| CELON ENT SYSTEM (K032838) | Celon AG Medical Instruments | 2003-09-26 |
| ATAC TOTAL BILIRUBIN REAGENT (K030014) | Elan Diagnostics | 2003-09-26 |
| SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045 (K032680) | Smith & Nephew, Inc. | 2003-09-26 |
| EXCISOR BIOPTOME, MODEL 01-0004 (K032847) | Acueity, Inc. | 2003-09-26 |
| COULTER LH 750 HEMATOLOGY ANALYZER (K032342) | Beckman Coulter, Inc. | 2003-09-26 |
| MAKY 21.1 DIALYZER REPROCESSING SYSTEM (K024076) | Hdc Maquinolas, LLC | 2003-09-26 |
| DW 296 #15 SOLDER (K032715) | Ivoclar Vivadent, Inc. | 2003-09-26 |
| SENTINOL NITINOL BILLARY STENT SYSTEM (K032025) | Boston Scientific Corp | 2003-09-25 |
| BLINK CL LUBRICANT EYE DROPS (K032030) | Advanced Medical Optics, Inc. | 2003-09-25 |
| RATTAN IMACS BY RATTAN INFORMATION CORPORATION (K032176) | Rattan Information Corporation | 2003-09-25 |
| HRK-63-8 KNEE ARRAY COIL (K032633) | Mri Devices Corp. | 2003-09-25 |
| OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER (K030393) | Haag-Streit Holding AG | 2003-09-25 |
| SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT (K032497) | Micro Therapeutics, Inc. | 2003-09-25 |
| RINSPIRATION SYSTEM (K031485) | Kerberos Proximal Solutions | 2003-09-25 |
| EXOMIO, MODEL 2.0 SP1 (K032550) | Medcom GmbH | 2003-09-25 |
| NUMED TYSHAK MINI PEDIATRIC PTV CATHETER (K032591) | NuMED, Inc. | 2003-09-25 |
| PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 (K032248) | Aktina Medical Physics Corp. | 2003-09-25 |
| ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW (K032355) | Dentsply Gendex | 2003-09-25 |
| EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM (K031898) | Ekf Diagnostic GmbH | 2003-09-24 |
| INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC (K032780) | Inviro Medical | 2003-09-24 |
| AIR PRESS MASSAGER (K032505) | Telebrands Corp | 2003-09-24 |