| UNIVERSAL DENTAL COPING (UDC) (K010467) | Paxmed International | 2001-09-28 |
| AQUA WATER TREATMENT FOR HEMODIALYSIS (K010592) | Aqua Water Treatment, Inc. | 2001-09-28 |
| CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE (K012934) | Abbott Laboratories | 2001-09-28 |
| SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM (K012114) | Synthes (Usa) | 2001-09-28 |
| MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 (K012926) | Endocardial Solutions, Inc. | 2001-09-28 |
| ADC COMPACT PLUS (K013138) | Agfa-Gevaert AG | 2001-09-28 |
| DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM (K012797) | Diamedix Corp. | 2001-09-28 |
| 2010 PLUS HOLTER FOR WINDOWS (K010949) | Agilent Technologies | 2001-09-28 |
| UNIPLANT DENTAL IMPLANT SYSTEM (K011574) | Universal Implant Systems, Inc. | 2001-09-28 |
| RANDOX LIPOPROTEIN (K011568) | Randox Laboratories, Ltd. | 2001-09-28 |
| SYSMEX UF-50 (K012372) | Sysmex Corp. | 2001-09-28 |
| MODIFICATION TO N PROTEIN STANDARD SL (K012470) | Dade Behring, Inc. | 2001-09-28 |
| VERTEX RECONSTRUCTION SYSTEM (K003780) | Medtronic Sofamor Danek, Inc. | 2001-09-28 |
| ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL (K010749) | Biomedical Life Systems, Inc. | 2001-09-28 |
| DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM (K012173) | Sulzer Spine-Tech | 2001-09-28 |
| MIS IMPLANT SYSTEM DECIVE (K003191) | Mis Implants Technologies , Ltd. | 2001-09-28 |
| STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM (K012270) | Stryker Endoscopy | 2001-09-28 |
| BLUE SKY BIO DENTAL IMPLANT SYSTEM (K010882) | Blue Sky Bio | 2001-09-28 |
| DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM (K012795) | Diamedix Corp. | 2001-09-28 |
| MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR (K012428) | Medtronic Physio-Control Corp. | 2001-09-28 |
| TE ME NA POLYSTIM NERVE STIMILATOR (K990323) | Te ME NA S.A.R.L. | 2001-09-28 |
| LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL (K012907) | Clinical Controls | 2001-09-28 |
| OMNICARE DENTAL IMPLANT SYSTEM (K000035) | Omnicare Dental Implant Center | 2001-09-28 |
| AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER (K012939) | Monaghan Medical Corp. | 2001-09-28 |
| 3I LOCATER ABUTMENT SYSTEM (K012911) | Implant Innovations, Inc. | 2001-09-28 |
| RAPIDIA (K012290) | 3D Med Co., Ltd. | 2001-09-28 |
| VYGON SPLIT CANNULA INTRODUCER (K010913) | Vygon Corp. | 2001-09-28 |
| REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT (K013077) | Corgenix, Inc. | 2001-09-28 |
| VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM) (K010732) | Telemedic Systems, Inc. | 2001-09-27 |
| VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS (K011800) | Vanguard Medical Concepts, Inc. | 2001-09-27 |
| EXEL INJECTION PLUG WITH CAP (K011405) | Exelint Intl. Co. | 2001-09-27 |
| NUMARIS 4VA15A (K012202) | Siemens Medical Corp. | 2001-09-27 |
| COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 (K012160) | Premier Dental Products Co. | 2001-09-27 |
| PF2 (K012062) | Fixano SA | 2001-09-27 |
| AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T (K013084) | Medtronic Perfusion Systems | 2001-09-27 |
| SLENDERTONE FLEX, MODEL, 512 (K010335) | Bio-Medical Research, Ltd. | 2001-09-27 |
| DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES (K010712) | Molded Products, Inc. | 2001-09-27 |
| RADIOFIX (K012078) | Fixano SA | 2001-09-27 |
| DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR (K010478) | Dideco | 2001-09-27 |
| COLOR-MONOGEN (K012901) | Instrumentation Laboratory CO | 2001-09-27 |
| BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM (K011970) | Biosafe Laboratories, Inc. | 2001-09-26 |
| POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 (K011961) | Shen Wei (Usa), Inc. | 2001-09-26 |
| THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 (K012866) | Implex Corp. | 2001-09-26 |
| THE INTUITIVE COLORIMETER (K012298) | Cerium Optical Technologies, Inc. | 2001-09-26 |
| URISYS 2400 URINE TEST STRIP (K012397) | Roche Diagnostics Corp. | 2001-09-26 |
| BLY-501 ADAPTOR (K012540) | Micromedical Industries, Ltd. | 2001-09-26 |
| SONOREAL 3D (K012084) | Bio Medi Com | 2001-09-26 |
| STERILE NITRILE SURGICAL GLOVES (POWDERED) (K012479) | Smart Glove Corp. Sdn Bhd | 2001-09-26 |
| FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM (K011877) | Carl Zeiss Jena GmbH | 2001-09-26 |
| ACCUIMAGE SMARTGATE UPGRADE (K012106) | Accuimage Diagnostics Corp. | 2001-09-25 |
| EASY GUIDE ELECTROSURGICAL ACCESS DEVICE (K012004) | Senorx, Inc. | 2001-09-25 |
| HP-ONE (K012411) | Gi Supply | 2001-09-25 |
| ULTRAFLEX EV HEMOSTASIS INTRODUCER (K012922) | St Jude Medical | 2001-09-25 |
| XBO1-824-18/19/20 BIOPSY FORCEPS (K012074) | The Olympus Optical Co. | 2001-09-25 |
| MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 (K010891) | Digene Corp. | 2001-09-25 |
| SUPERSTITCH VASCULAR SUTURING DEVICE (K012865) | Sutura, Inc. | 2001-09-25 |
| MODIFICATION TO: QWH-420 WRIST ARRAY COIL (K013099) | Mri Devices Corp. | 2001-09-25 |
| BREATHABLE IMPERVIOUS GOWNS (K012984) | Allegiance Healthcare Corp. | 2001-09-24 |
| XIA STAINLESS STEEL SYSTEM (K012870) | Howmedica Osteonics Corp. | 2001-09-24 |
| MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (K010892) | Digene Corp. | 2001-09-24 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM (K012149) | Allegiance Healthcare Corp. | 2001-09-24 |
| VACUETTE EDTA K2 GEL TUBES (K012043) | Greiner Vacuette North America, Inc. | 2001-09-24 |
| MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 (K010893) | Digene Corp. | 2001-09-24 |
| RAICHEM MULTI-ANALYTE CALIBRATOR (K012250) | Hemagen Diagnostics, Inc. | 2001-09-24 |
| AOS MODULAR FEMORAL NAIL (K012190) | Advanced Orthopaedic Solutions, Inc. | 2001-09-24 |
| PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT (K011017) | Rehabilicare, Inc. | 2001-09-24 |
| GE SIGNA ASSET IMAGING OPTION (K012970) | GE Medical Systems | 2001-09-24 |
| PORTABLE INTENSIVE CARE UNIT (K012030) | Medical Research Laboratories, Inc. | 2001-09-24 |
| LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET (K011341) | Lh Medical Products, Inc. | 2001-09-21 |
| NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K012863) | Sgmp Co., Ltd. | 2001-09-21 |
| AUDIOSCAN VERIFIT, MODEL VF-1 (K012306) | Etymonic Design, Inc. | 2001-09-21 |
| SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) (K012456) | Sodemsystems | 2001-09-21 |
| ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION (K012904) | Bayer Diagnostics Corp. | 2001-09-21 |
| AETMED IMAGE PROCESSING SOFTWARE (K012093) | Aetmed, S.P.A. | 2001-09-21 |
| ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K (K010844) | Astoria-Pacific, Inc. | 2001-09-21 |
| NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O (K012857) | Sgmp Co., Ltd. | 2001-09-21 |
| LH 500 ENTERAL FEEDING GRAVITY BAG SET (K011343) | Lh Medical Products, Inc. | 2001-09-21 |
| SQA, SPERM QUALITY ANALYZER (K012352) | Medical Electronic Systems, LLC | 2001-09-21 |
| PRE-POWDERED NITRILE EXAMINATION GLOVES (K010232) | P.T. Healthcare Glovindo | 2001-09-21 |
| COLLAGEN NERVE CUFF (K012814) | Collagen Matrix, Inc. | 2001-09-21 |
| POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G) (K012860) | Sgmp Co., Ltd. | 2001-09-21 |
| WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 (K012329) | Wiener Laboratories Saic | 2001-09-21 |
| LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT (K011340) | Lh Medical Products, Inc. | 2001-09-21 |
| STS RANGE , MODELS STS20,STS30,STS40 (K012008) | Huntleigh Healthcare, Inc. | 2001-09-21 |
| MALE LATEX CONDOM (K012653) | Qingdao Shuang Die Latex Production Co.,Ltd | 2001-09-21 |
| INTRA OPERATIVE RADIATION THERAPY (K004023) | Arplay Medical S.A. | 2001-09-21 |
| COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX) (K000122) | Neucoll, Inc. | 2001-09-20 |
| QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM (K002241) | Quantum Bioengineering, Ltd. | 2001-09-20 |
| MULTIFUNCTION ENDOSCOPIC INSTRUMENT (K012033) | Seedling Enterprises., LLC | 2001-09-20 |
| QUANTUM VERSATILITY IMPLANT SYSTEM (K991250) | Quantum Bioengineering, Ltd. | 2001-09-20 |
| GSA GENITO SENSORY ANALYZER (K010981) | Medoc Ltd. Advanced Medical Systems | 2001-09-20 |
| SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C (K011988) | Cardiofocus, Inc. | 2001-09-20 |
| KINETIC CANNULA (K012042) | Reliance Medical Corp. | 2001-09-20 |
| INSIGHT MILLENNIUM PLUS (K011964) | Fasstech | 2001-09-20 |
| OPTIBOND SOLO PLUS ACTIVATOR (K012082) | Sybron Dental Specialties, Inc. | 2001-09-20 |
| REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT (K013018) | Corgenix, Inc. | 2001-09-20 |
| QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM (K011223) | Paxmed International | 2001-09-20 |
| PATTON ENDO-BAG (K012150) | Patton Medical Corp. | 2001-09-20 |
| MODIFICATION TO LR 5200 FILM RECORDER (K012010) | Agfa Corp. | 2001-09-20 |
| PRECLUDE PERICARDIAL MEMBRANE (K012098) | W. L. Gore & Associates, Inc. | 2001-09-20 |