| MODEL 2500A PALMSAT PULSE OXIMETER (K050056) | Nonin Medical, Inc. | 2005-06-21 |
| FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) (K051519) | Abbott Laboratories (Perclose, Inc.) | 2005-06-21 |
| OMRON MODEL 514N TYMPANIC THERMOMETER (K051233) | Omron Healthcare, Inc. | 2005-06-21 |
| MODEL 250 SERIES MATERNAL/FETAL MONITOR (K050583) | Ge Medical Systems Information Technologies | 2005-06-21 |
| GE DATEX-OHMEDA CENTIVA/5 VENTILATOR (K050860) | Datex-Ohmeda, Inc. | 2005-06-21 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K051148) | Zibo Sinocare Plastic Products Co., Ltd. | 2005-06-21 |
| SPI DENTAL IMPLANT (K051502) | Thommen Medical AG | 2005-06-21 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML (K051183) | Becton, Dickinson & CO | 2005-06-21 |
| CAVEX ORTHOTRACE (K051207) | Cavex Holland BV | 2005-06-21 |
| ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS (K051335) | Exactech, Inc. | 2005-06-21 |
| KODAK DIRECTVIEW DR SYSTEM DETECTOR (K051483) | Eastman Kodak Company | 2005-06-21 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) (K051154) | Hebei Manful Import & Export Co., Ltd. | 2005-06-20 |
| REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER (K050995) | Volcano Corporation | 2005-06-20 |
| MANZI CLEANER SYSTEM (K043314) | Langford IC Systems, Inc. | 2005-06-20 |
| POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR (K051317) | Platinum Glove Industries Sdn. Bhd. | 2005-06-20 |
| 30 ML OR 60 ML PEDI-SYRINGE FILTER (K050805) | Blood Products Specialties, LLC | 2005-06-20 |
| NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED (K051563) | Terang Nusa Sdn Bhd | 2005-06-20 |
| ANEROID SPHYGMANOMETER WITH STETHOSCOPE, MODEL HS-50A (K051021) | Shanghai Lord International Trade Co., Ltd. | 2005-06-20 |
| SENTINEL CHOLINESTERASE LIQUID (K051444) | Sentinel Ch. Srl | 2005-06-20 |
| PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 (K051367) | Ge Medical Systems Information Technologies | 2005-06-20 |
| ZODIAC SPINAL FIXATION SYSTEM (K051286) | Alphatec/Nexmed | 2005-06-17 |
| HOFFMANN II MRI EXTERNAL FIXATION SYSTEM (K051306) | Howmedica Osteonics Corp. | 2005-06-17 |
| MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM (K050456) | Medrad, Inc. | 2005-06-17 |
| POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR) (K051318) | Platinum Glove Industries Sdn. Bhd. | 2005-06-17 |
| PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT (K051379) | Ev3 Corporation | 2005-06-17 |
| POLYGRAFT BGS; BONE GRAFT SUBSTITUTE (K041382) | Osteobiologics, Inc. | 2005-06-17 |
| PARALLAX ACRYLIC RESIN WITH TRACERS TA (K050864) | Arthrocare Corp. | 2005-06-17 |
| MEDLITE C1 Q-SWITCHED ND:YAG LASER (K050696) | Hoya Photonics, Inc. | 2005-06-17 |
| POLYFORM SYNTHETIC MESH (K051245) | Proxy Biomedical , Ltd. | 2005-06-17 |
| TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 (K051196) | Implex Corp. | 2005-06-17 |
| ELECSYS RBC FOLATE HEMOLYZED REAGENT (K051292) | Roche Diagnostics Corp. | 2005-06-17 |
| THE INCOURAGE SYSTEM (K051383) | Respiratory Technologies, Incorporated | 2005-06-17 |
| ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM (K043176) | Arc Surgical, LLC | 2005-06-17 |
| WHS-1000 WOUND HEALING SYSTEM (K050156) | Iyia Technologies, Inc. | 2005-06-17 |
| SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS (K051432) | Arkray, Inc. | 2005-06-17 |
| AMS COLLAGEN DERMAL MATRIX (K050445) | American Medical Systems, Inc. | 2005-06-17 |
| FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A (K051500) | Toshiba America Medical Systems, In.C | 2005-06-17 |
| IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A (K050847) | Theratech, Inc. | 2005-06-17 |
| SPYSCOPE ACCESS AND DELIVERY CATHETER (K051504) | Boston Scientific Corp | 2005-06-16 |
| SONOTIP II ULTRASOUND NEEDLE SYSTEM (K051247) | Medi-Globe Corp. | 2005-06-16 |
| SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA (K051416) | Mallinckrodt Medical | 2005-06-16 |
| ENERGEX (K042686) | Energex Systems, Inc. | 2005-06-16 |
| ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS (K050910) | Roei Medical Technologies, Ltd. | 2005-06-16 |
| ACCU02 SYSTEM (K051007) | Miti Corp. | 2005-06-16 |
| EYE CUP, STERILE 1 AND NON STERILE (K051414) | Tollot Pty.Ltd.(Aaxis Pacific) | 2005-06-16 |
| EASY CORE DETACHABLE BIOPSY SYSTEM (K051361) | Boston Scientific Corp | 2005-06-16 |
| GE VIVID 7 WITH OR WITHOUT SUFFIX (K051449) | GE Medical Systems | 2005-06-16 |
| CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063 (K050998) | Confluent Surgical,Inc | 2005-06-15 |
| MODIFICATION TO: SECTRA IDS5 WORKSTATION (K051315) | Sectra Imtec AB | 2005-06-15 |
| 6 FR DL POWERPICC CATHETER (K050931) | C.R. Bard, Inc. | 2005-06-15 |
| BIPAP AUTO (K050759) | Respironics, Inc. | 2005-06-15 |
| LYSUS INFUSION SYSTEM (K051319) | Ekos Corp. | 2005-06-15 |
| DIADEXUS PLAC TEST (K050523) | Diadexus, Inc. | 2005-06-15 |
| MEDICON IMF-ORION SCREWS (K050478) | Medicon EG | 2005-06-15 |
| GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE (K051267) | W. L. Gore & Associates, Inc. | 2005-06-15 |
| SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM (K051326) | Smith & Nephew, Inc. | 2005-06-15 |
| BIODERM SCIENCES WOUND HEALING SPRAY (K042084) | Bioderm Sciences, Inc. | 2005-06-15 |
| SET (K051008) | Southern Dental Industries, Ltd. | 2005-06-15 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML (K051109) | Becton, Dickinson & CO | 2005-06-15 |
| ADVIA IMS LITHIUM ASSAY (K050374) | Bayer Healthcare, LLC | 2005-06-15 |
| PALOMAR LUXIR HANDPIECE (K050370) | Palomar Medical Technologies, Inc. | 2005-06-15 |
| C.CAM-AC (K051460) | Danish Diagnostic Development A/S | 2005-06-15 |
| WEBPAX, MODEL 200 (K051325) | Heart Imaging Technologies, LLC | 2005-06-15 |
| TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS) (K050428) | Advanced Spinal Technologies, Inc. | 2005-06-14 |
| LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P (K050919) | Analogic Corp. | 2005-06-14 |
| TRANS1 AXIALIF SYSTEM (K050965) | Trans1 Incorporated | 2005-06-14 |
| CONSTRUX MINI PEEK VBR SYSTEM (K051246) | Blackstone Medical, Inc. | 2005-06-14 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES COLORED (WHITE, YELLOW) (K051156) | Shijiazhuang Manful Light Industrial Products Co., | 2005-06-14 |
| CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM (K051293) | Ceremed , Inc. | 2005-06-14 |
| BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM (K043548) | Blackstone Medical, Inc. | 2005-06-14 |
| CD HORIZON SPINAL SYSTEM (K050809) | Medtronic Sofamor Danek USA, Inc. | 2005-06-14 |
| REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K051220) | Sterilmed, Inc. | 2005-06-14 |
| FRIADENT ESTHETICAP (K050208) | Dentsply International | 2005-06-14 |
| SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT (K051307) | Beckman Coulter, Inc. | 2005-06-13 |
| QUANTA LITE SP100 ELISA (K050662) | Inova Diagnostics, Inc. | 2005-06-13 |
| DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE (K051084) | Denver Biomedicals, Inc. | 2005-06-13 |
| OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS (K050733) | Lin-Zhi International, Inc. | 2005-06-13 |
| SERIM DIALYSATE MONITOR TEST STRIP (K043031) | Serim Research Corp. | 2005-06-13 |
| ATRICURE ISOLATOR TRANSPOLAR PEN (K050459) | AtriCure, Inc. | 2005-06-13 |
| INVIEW (K051321) | Metrika, Inc. | 2005-06-13 |
| ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM (K051402) | Gvi Technology Partners | 2005-06-13 |
| PV 1900 SYNCHRO 0.016 GUIDEWIRE (K050964) | Boston Scientific - Precision Vascular | 2005-06-13 |
| GOODKNIGHT 425ST (K050072) | Nellcor Puritan Bennett, Inc. | 2005-06-13 |
| MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS (K050727) | Nxstage Medical, Inc. | 2005-06-13 |
| ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY (K051265) | Bayer Healthcare, LLC | 2005-06-13 |
| CANDELA FAMILY OF PULSE DYE LASER SYSTEMS (K050673) | Candela Corp. | 2005-06-13 |
| SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC (K050649) | Noble Fiber Technologies, Inc. | 2005-06-13 |
| ARI COLD SPRAY (K033720) | Ari | 2005-06-10 |
| BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG (K051228) | Cardiodynamics International Corp. | 2005-06-10 |
| RIVA PROTECT (K050871) | Southern Dental Industries, Inc. | 2005-06-10 |
| XENFORM SOFT TISSUE REPAIR MATRIX (K051190) | Tei Biosciences, Inc. | 2005-06-10 |
| BIO-CONSOLE, MODEL 560 (K051303) | Medtronic Perfusion Systems | 2005-06-10 |
| EKOS MICRO-INFUSION SYSTEM (K051225) | Ekos Corp. | 2005-06-10 |
| LEVO COMFORT II (K051387) | Levo AG | 2005-06-10 |
| VELASMOOTH, SHAPER (K050397) | Syneron Medical, Ltd. | 2005-06-09 |
| SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) (K042164) | Medline Industries, Inc. | 2005-06-09 |
| OLPUR DIALYZER, MODEL HD 190 (K050603) | Nephros, Inc. | 2005-06-09 |
| SUPERCATH Z3V (K050114) | Togo Medikit Co., Ltd. | 2005-06-09 |
| MENDEC SPINE (K042415) | Tecres S.P.A. | 2005-06-09 |
| AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (K051250) | Axya Medical, Inc. | 2005-06-09 |