| KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K042418) | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | 2005-03-21 |
| MODIFICATION TO: RESTORATION MODULAR SYSTEM (K050138) | Howmedica Osteonics Corp. | 2005-03-21 |
| CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 (K042999) | Biosense Webster, Inc. | 2005-03-21 |
| VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K050021) | Vascular Solutions, Inc. | 2005-03-18 |
| RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 (K050125) | More Diagnostics | 2005-03-18 |
| POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A (K042727) | Foremount Ent. Co., Ltd. | 2005-03-18 |
| MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE (K050585) | Dade Behring, Inc. | 2005-03-18 |
| OMNILUX REVIVE AND BLUE (K043329) | Photo Therapeutics Limited | 2005-03-18 |
| AEU-14CF EXPENDITION (K050201) | Aseptico, Inc. | 2005-03-18 |
| STARSHIELD V3 RF TRNT (K050237) | Odin Medical Technologies , Ltd. | 2005-03-18 |
| TEMPTOUCH DERMAL THERMOMETER (K050137) | Xilas Medical, Inc. | 2005-03-18 |
| POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL (K050527) | Spi Gloves Sdn. Bhd. | 2005-03-18 |
| TEMPOSIL, MODEL 6720 (K050426) | Coltene/Whaledent AG | 2005-03-18 |
| CRYOCHECK CLOT S (K043571) | Precision Biologic, Inc. | 2005-03-18 |
| FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS (K050293) | Fotona D.D. | 2005-03-18 |
| TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) (K041311) | Tiger Medical Products, Ltd. | 2005-03-18 |
| XP TECHNOLOGY ULTRASONIC SCALER (K042972) | American Eagle Instruments, Inc. | 2005-03-18 |
| RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES (K042523) | Richard Wolf Medical Instruments Corp. | 2005-03-18 |
| UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS (K033577) | Medlink Imaging | 2005-03-18 |
| POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) (K050531) | Spi Gloves Sdn. Bhd. | 2005-03-18 |
| ISIS MER SYSTEM/ELEKTA MER SYSTEM (K042208) | Inomed Medizintechnik GmbH | 2005-03-18 |
| 550 TXT TREATMENT TABLE (K050422) | Siemens Medical Solutions USA, Inc. | 2005-03-18 |
| ACCU-CHEK SPIRIT (K042887) | Disetronic Medical Systems AG | 2005-03-18 |
| DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX (K040262) | Musculoskeletal Transplant Foundation | 2005-03-17 |
| NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 (K043436) | Nxstage Medical, Inc. | 2005-03-17 |
| PERSONAL WARMING JELLY (K050212) | Qualis, Inc. | 2005-03-17 |
| IMAGENPRO (K050366) | Cardiovascular Imaging Technologies, LLC | 2005-03-17 |
| GE DISCOVERY VCT SYSTEM (K050559) | GE Medical Systems | 2005-03-17 |
| BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR (K043451) | Hyphen Biomed | 2005-03-17 |
| PERSONAL WARMING GEL (K050211) | Qualis, Inc. | 2005-03-17 |
| STABILIZATION SCREW (K050346) | New Deal, S.A. | 2005-03-17 |
| STRYKER MMF SCREW (K050535) | Stryker Instruments | 2005-03-17 |
| ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 (K050255) | Gendex Dental Systems | 2005-03-17 |
| V-BAG WITH GBS COATING (K050195) | Gish Biomedical, Inc. | 2005-03-17 |
| COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; (K050084) | Cosman Medical, Inc. | 2005-03-17 |
| ENFANTTM (K043491) | Diopsys, Inc. | 2005-03-16 |
| REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER (K033436) | Alliance Medical Corp. | 2005-03-16 |
| HEMOCATH (K043292) | Med-Conduit, Inc. | 2005-03-16 |
| BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE (K050184) | Regent Medical Americas, LLC | 2005-03-16 |
| STRYKER URETEROSCOPE (K043021) | Stryker Endoscopy | 2005-03-16 |
| MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES (K032666) | Medline Industries, Inc. | 2005-03-16 |
| NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) (K050214) | Hartalega Sdn Bhd | 2005-03-16 |
| AEQUALIS REVERSED SHOULDER PROSTHESIS (K050316) | Tornier | 2005-03-16 |
| STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 (K043004) | Viasys Medsystems | 2005-03-16 |
| SPECTRANETICS LLD CS, MODEL 518-039 (K043401) | Spectranetics Corp. | 2005-03-16 |
| IMMUNOCARD STAT! FLU A & B (K041626) | Meridian Bioscience, Inc. | 2005-03-16 |
| POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER (K050529) | Spi Gloves Sdn. Bhd. | 2005-03-16 |
| ULTRA MIRAGE II MASK (K050359) | Resmed, Ltd. | 2005-03-16 |
| ABILITY POWER GURNEY (K042699) | Gator Custom Mobility, Inc. | 2005-03-16 |
| TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) (K050091) | Direx Systems Corp. | 2005-03-16 |
| SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS (K042899) | Synthes (Usa) | 2005-03-16 |
| POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) (K050530) | Spi Gloves Sdn. Bhd. | 2005-03-16 |
| ENDOMARK STERILE INDIA INK (K042901) | Pmt Corp. | 2005-03-16 |
| EXCIA TOTAL HIP SYSTEM (K042344) | Aesculap, Inc. | 2005-03-16 |
| COMPEL MLR SURGICAL GOWNS (K041541) | Standard Textile Co., Inc. | 2005-03-16 |
| STRYKER FLEXIBLE CYSTONEPHROSCOPE (K043022) | Stryker Endoscopy | 2005-03-15 |
| CELLTRACKA ANALYZER II (K050145) | Immunicon Corp. | 2005-03-15 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K050245) | Veridex, LLC | 2005-03-15 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML (K043458) | Becton, Dickinson & CO | 2005-03-15 |
| PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 (K050112) | Prime Pacific Health Innovations Corporation | 2005-03-15 |
| CEDIA TACROLIMUS ASSAY (K050206) | Microgenics Corp. | 2005-03-15 |
| OMNILUX PLUS (K043317) | Photo Therapeutics Limited | 2005-03-15 |
| VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) (K050362) | Vident | 2005-03-15 |
| EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM (K040883) | Advanced Sterilization Products | 2005-03-15 |
| SYNTHES MANDIBLE EXTERNAL FIXATOR (K050378) | Synthes (Usa) | 2005-03-15 |
| GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE (K043144) | Gen-Probe, Inc. | 2005-03-14 |
| VAPORMAX (K050412) | Trimedyne, Inc. | 2005-03-14 |
| MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM (K050457) | Merete Medical GmbH | 2005-03-14 |
| LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER (K050344) | Ethicon Endo Surgery, Inc. | 2005-03-14 |
| SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE (K042515) | Smith & Nephew, Inc. | 2005-03-14 |
| SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 (K043511) | Soleus Champ International Co., Ltd. | 2005-03-14 |
| STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER (K042169) | Stanbio Laboratory | 2005-03-14 |
| VENTILAIR II MEDICAL AIR COMPRESSOR (K041781) | Hamilton Medical AG | 2005-03-14 |
| UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD (K043570) | Conformis, Inc. | 2005-03-14 |
| MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE (K050361) | Boston Scientific Corp | 2005-03-14 |
| MODEL BMLS03-7 (K042711) | Biomedical Life Systems, Inc. | 2005-03-14 |
| PINNACLE CONSTRAINED ACETABULAR LINERS (K043058) | Depuy, Inc. | 2005-03-14 |
| SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS (K050108) | Innovaquartz | 2005-03-14 |
| TAMARACK ANTERIOR THORACOLUNBAR (K050390) | Alphatec/Nexmed | 2005-03-14 |
| AOS HUMERAL NAIL (K050241) | Advanced Orthopaedic Solutions, Inc. | 2005-03-14 |
| WU'S 4-WHEELED NEO SCOOTER, WT-XL4 (K050042) | Wu'S Tech Co., Ltd. | 2005-03-14 |
| INTEGRA BONE FIXATION SYSTEM (K050492) | Integra Lifesciences Corp. | 2005-03-14 |
| MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050501) | Abbott Vascular Devices | 2005-03-14 |
| RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR (K050232) | Boston Scientific Corp | 2005-03-11 |
| NITRILE POWDERED EXAMINATION GLOVES (WHITE) (K050215) | Hartalega Sdn Bhd | 2005-03-11 |
| SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, (K042556) | Enter Medical Corporation | 2005-03-11 |
| SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT (K041825) | Smith & Nephew, Inc. | 2005-03-11 |
| BODYGUARD INFUSION PUMP SYSTEM (K042696) | Caesarea Medical Electronics , Ltd. | 2005-03-11 |
| INNOVA 2100 (K050489) | Ge Medical Systems, LLC | 2005-03-11 |
| HARVEST GRAFT DELIVERY SYRINGE (K043261) | Harvest Technologies, Corp. | 2005-03-11 |
| LYSUS INFUSION SYSTEM (K050472) | Ekos Corp. | 2005-03-11 |
| ONLINE DAT PROPOXYPHENE PLUS (K043303) | Roche Diagnostics Corp. | 2005-03-11 |
| VISION (K042956) | Varian Medical Systems, Inc. | 2005-03-11 |
| UNDER BUTTOCKS DRAPE (K042893) | International Medsurg Connection, Inc. | 2005-03-11 |
| MODIFICATION TO DYNESYS SPINAL SYSTEM (K043565) | Zimmer Spine, Inc. | 2005-03-11 |
| ON CALL MULTI-DRUG HOME TEST (K050050) | ACON Laboratories, Inc. | 2005-03-11 |
| VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K040751) | Vanguard Medical Concepts, Inc. | 2005-03-10 |
| ENDOLINK TRUE MOVEMENT SYSTEM (K043541) | Novare Surgical Systems, Inc. | 2005-03-10 |
| HYPERQ SYSTEM (K042981) | Biological Signal Processing, Ltd. | 2005-03-10 |
| VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE (K042952) | Zibo Hengchang Plastic & Rubber Products Co., Ltd. | 2005-03-10 |