| MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 (K013167) | Newcare Products, LLC | 2002-01-30 |
| BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 (K012702) | Endotec, Inc. | 2002-01-30 |
| LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE (K012551) | Biomet, Inc. | 2002-01-30 |
| 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM (K020045) | Biomet Orthopedics, Inc. | 2002-01-30 |
| RAVEN BACTERIAL SPORE STRIPS (K020026) | Raven Biological Laboratories, Inc. | 2002-01-30 |
| DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (K012924) | Datex-Ohmeda, Inc. | 2002-01-30 |
| THERMAGE THERMACOOL TC SYSTEM (K013639) | Thermage, Inc. | 2002-01-29 |
| PYRAMID ANTERIOR PLATE FIXATION SYSTEM (K013665) | Medtronic Sofamor Danek, Inc. | 2002-01-29 |
| SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS (K013641) | Senorx, Inc. | 2002-01-29 |
| METAVISION CLINICAL INFORMATION SYSTEM (K012349) | Imdsoft, Ltd. | 2002-01-29 |
| MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER (K020012) | Boston Scientific/Medi-Tech | 2002-01-29 |
| RHODIA BITE REGISTRATION MATERIAL (K013859) | Rhodia, Inc. | 2002-01-29 |
| REMSTAR AUTO CPAP SYSTEM (K012554) | Respironics, Inc. | 2002-01-29 |
| CORTISOL LIA (K010790) | Kmi Diagnostics, Inc. | 2002-01-29 |
| SEEDNET, MODEL FP6T5, FP5T5, FP5T3 (K011950) | Galil Medical , Ltd. | 2002-01-29 |
| BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS (K013959) | Bayer Diagnostics Corp. | 2002-01-29 |
| JETSONIC 2000 (K014245) | Deldent , Ltd. | 2002-01-29 |
| COOLBLU2 DENTAL RESIN CURING DEVICE (K020171) | Dental Systems.Com, Inc. | 2002-01-29 |
| CIC-C1Q EIA (K012576) | American Laboratory Products Co., Ltd. | 2002-01-29 |
| MINI SHOPPER (K013927) | Shoprider Intl., Inc. | 2002-01-28 |
| JOBST READY-TO-WEAR GAUNTLET (K013852) | Bsn-Jobst, Inc. | 2002-01-28 |
| CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM (K013922) | Barco N.V. | 2002-01-28 |
| NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING (K014055) | Seal Polymer Industries Bhd. | 2002-01-28 |
| EXCITE SELF ETCH (K013584) | Ivoclar Vivadent, Inc. | 2002-01-28 |
| HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ (K010378) | Implex Corp. | 2002-01-28 |
| CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM (K012089) | Catheffects, LLC | 2002-01-28 |
| IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (K013938) | Diametrics Medical, Inc. | 2002-01-28 |
| DOC BAND (K014012) | Cranial Technologies, Inc. | 2002-01-28 |
| SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED (K014021) | Surgical Specialties Corp | 2002-01-28 |
| VOXAR'S CALCIUM SCORING PRODUCT (K020140) | Voxar Limited | 2002-01-28 |
| SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR (K014103) | Beckman Coulter, Inc. | 2002-01-28 |
| DEPUY FEMORAL HEADS (K011533) | DePuy Orthopaedics, Inc. | 2002-01-28 |
| MEDIPORT 2000 MOBILE (K013585) | Servox Medizintechnik GmbH | 2002-01-28 |
| BCC GAMMA CAMERA (K013667) | Is2 Research, Inc. | 2002-01-28 |
| WIENER LAB. ALP 405 (K013983) | Wiener Laboratories Saic | 2002-01-28 |
| SALINE IV FLUSH SYRINGE (K002142) | Emt-Rx | 2002-01-28 |
| HI-ART SYSTEM (K013673) | Tomo Therapy, Inc. | 2002-01-28 |
| ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM (K013091) | Von Zeppelin GmbH | 2002-01-25 |
| MODIFICATION TO THE MAESTRO SYSTEM (K020133) | BioHorizons Implant Systems, Inc. | 2002-01-25 |
| PERICSCOPE, MODEL # PERISC1 (K013576) | Ethicon Endo-Surgery, Inc. | 2002-01-25 |
| ULTRAMAX WOVEN VELOUR VASCULAR GRAFT (K013577) | Atrium Medical Corp. | 2002-01-25 |
| FINGER JOINT PROSTHESIS (K013629) | Avanta Orthopaedics, Inc. | 2002-01-25 |
| UNITRAX MODULAR UNIPOLAR SYSTEM (K014226) | Howmedica Osteonics Corp. | 2002-01-25 |
| T2 FEMORAL NAIL SYSTEM (K014220) | Howmedica Osteonics Corp. | 2002-01-25 |
| CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 (K013392) | Medtronic Vascular | 2002-01-25 |
| PERIFIX SAFETY EPIDURAL NEEDLES (K013610) | B.Braun Medical, Inc. | 2002-01-25 |
| KNEE MODULE FOR THE STEALTHSTATION SYSTEM (K012937) | Medtronic Surgical Navigation Technologies | 2002-01-25 |
| MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 (K014294) | Medical Data Electronics | 2002-01-25 |
| COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH (K013507) | Cosmo Health, Inc. | 2002-01-25 |
| KPS-I, THE KIDNEY PERFUSION SOLUTION (K013575) | Organ Recovery Systems, Inc. | 2002-01-25 |
| MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM (K014223) | Medtronic Percusurge, Inc. | 2002-01-25 |
| BUTTERFLY PLATE FIXATION SYSTEM (K014267) | Medtronic Sofamor Danek, Inc. | 2002-01-25 |
| CRYOCARE SURGICAL SYSTEM (K011074) | Endocare, Inc. | 2002-01-25 |
| RIBBOND - TRIAXIAL (K013881) | Ribbond, Inc. | 2002-01-25 |
| MODIFICATION TO OPUS SPINAL SYSTEM (K014229) | Howmedica Osteonics Corp. | 2002-01-25 |
| LUXATEMP/LUXATEMP SOLAR/INSTATEMP (K013674) | Dmg USA, Inc. | 2002-01-24 |
| EPS320 CARDIAC STIMULATOR (K011826) | Micropace Pty, Ltd. | 2002-01-24 |
| HEMOCHRON JR. CITRATE APTT CUVETTE (K014008) | Itc, Inc. | 2002-01-24 |
| BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 (K012749) | Biocardia, Inc. | 2002-01-24 |
| PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 (K013120) | Medamicus, Inc. | 2002-01-24 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS (K013899) | Ortho-Clinical Diagnostics | 2002-01-24 |
| SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY (K013636) | GE Medical Systems | 2002-01-24 |
| MULTI-SNARE SET (K011783) | Pfm Produkte Fur Die Medizin AG | 2002-01-24 |
| HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K012534) | Advanced Cardiovascular Systems, Inc. | 2002-01-24 |
| DELSONIC 2000 (K014238) | Deldent , Ltd. | 2002-01-24 |
| CAPTIAM SYPHILIS-G ASSAY (K014233) | Trinity Biotech, Plc | 2002-01-24 |
| COALESCENT SURGICAL U-CLIP (K013664) | Coalescent Surgical | 2002-01-24 |
| SAFE (K013773) | Ssn Medical Products Sdn. Bhd. | 2002-01-24 |
| PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY (K011185) | Psychemedics Corp. | 2002-01-24 |
| MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS (K013964) | Cp Medical | 2002-01-24 |
| ANCURE SHEATH MODEL # 40315, 40320, 40325 (K003889) | Guidant Cardiac and Vascular Surgery | 2002-01-24 |
| BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE (K011967) | Bd | 2002-01-23 |
| PORTABLE INTENSIVE CARE UNIT (K012766) | Medical Research Laboratories, Inc. | 2002-01-23 |
| SCI-PHARM POST SECURE (K013555) | Scientific Pharmaceuticals, Inc. | 2002-01-23 |
| CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER (K013303) | Latexx Manufacturing Sdn.Bhd. | 2002-01-23 |
| POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) (K020019) | Wrp Asia Pacific Sdn. Bhd. | 2002-01-23 |
| VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300) (K011625) | Vasocor, Inc. | 2002-01-23 |
| KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E (K010923) | Siemens Elema AB | 2002-01-23 |
| INTRAORAL LENS OPTION TO SPECTROSHADE (K012744) | Mht Optic Research AG | 2002-01-23 |
| BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW (K013558) | Blackstone Medical, Inc. | 2002-01-23 |
| PRECISION PLUS TUNA OFFICE SYSTEM (K014224) | Vidamed, Inc. | 2002-01-23 |
| EXEL COMFORTPOINT INSULIN PEN NEEDLE (K011757) | Exelint Intl. Co. | 2002-01-23 |
| ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT (K013465) | Diabetes Technologies, Inc. | 2002-01-22 |
| STIMULUS - DISSECTION INSTRUMENTS (K014165) | Medtronic Xomed, Inc. | 2002-01-22 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K013794) | Shen Wei (Usa), Inc. | 2002-01-22 |
| POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) (K014134) | Supergrade Healthcare Products Sdn. Bhd. | 2002-01-22 |
| WEINMANN SOMNOMASK (K013738) | Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits | 2002-01-22 |
| CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX (K012602) | Crosstex Intl. | 2002-01-22 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR (K013795) | Shen Wei (Usa), Inc. | 2002-01-22 |
| MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION (K013620) | Medstone Intl., Inc. | 2002-01-22 |
| R&D RET-LINE KIT (K013898) | R&D Systems, Inc. | 2002-01-22 |
| POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K013262) | Great Glove (Thailand) Co. , Ltd. | 2002-01-22 |
| DIOMED 15 DIODE LASER (K012398) | Diomed, Ltd. | 2002-01-22 |
| POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS (K013793) | Shen Wei (Usa), Inc. | 2002-01-22 |
| BODY ARRAY COIL (K013594) | Usa Instruments, Inc. | 2002-01-22 |
| PUMP TUBING (K013578) | Terumo Cardiovascular Systems Corp. | 2002-01-22 |
| VANGUARD REPROCESSED INFLATION DEVICES (K012480) | Vanguard Medical Concepts, Inc. | 2002-01-22 |
| INFINION 0.6T MR IMAGING SYSTEM (K013858) | Philips Medical Systems (Cleveland), Inc. | 2002-01-22 |
| 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX (K020028) | Boston Scientific | 2002-01-22 |
| UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES (K013163) | N.S. Uni-Gloves Sdn. Bhd. | 2002-01-22 |