| EPI-MAX (K041059) | Dermagenics, Inc. | 2005-05-17 |
| THEKEN REVEAL VBR SYSTEM (K050058) | Theken Surgical,Llc | 2005-05-17 |
| NEUROSYSTEMS 1TM MONITOR (K050702) | Neurosystems, LLC | 2005-05-17 |
| ADVANCED TURBO DRIVE SYSTEM (K050519) | Linvatec Corp. | 2005-05-17 |
| CD HORIZON SPINAL SYSTEM (K050981) | Medtronic Sofamor Danek USA, Inc. | 2005-05-17 |
| ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER (K051002) | Ethicon Endo-Surgery, Inc. | 2005-05-17 |
| MICROTEK EQUIPMENT DRAPES (K050322) | Microtek Medical, Inc. | 2005-05-17 |
| DERMACYN WOUND IRRIGATION (K042729) | Oculus Innovative Sciences, Inc. | 2005-05-17 |
| PROBLOC, HN SERIES AND PROLONG, PL SERIES (K050499) | Life-Tech, Inc. | 2005-05-17 |
| MODIFICATION TO: VOYAGER LINUX (K050973) | Mako Surgical Corp. | 2005-05-17 |
| LANX SPINAL FIXATION SYSTEM (K043484) | Lanx, LLC | 2005-05-16 |
| TISSUE FIXATION SYSTEM (K050418) | Tfs Manufacturing Pty, Ltd. | 2005-05-16 |
| ENCOR 7 GAUGE (K051158) | Senorx, Inc. | 2005-05-16 |
| DELTA HUMERAL CUPS (K050315) | DePuy Orthopaedics, Inc. | 2005-05-16 |
| DR. THEISS ALERGOL POLLEN BLOCKER CREAM (K042610) | Dr. Theiss Naturwaren GmbH | 2005-05-16 |
| POLYPROPILENE SURGICAL SUTURES (K043330) | Demetech Corp. | 2005-05-16 |
| IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT (K050741) | Ind Diagnostic, Inc. | 2005-05-16 |
| NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000;NCAM1000 (K050650) | Cytyc Surgical Products | 2005-05-16 |
| MEDIOSTAR XT (K050900) | Asclepion Laser Technologies GmbH | 2005-05-16 |
| IRMA TRUPOINT CREATININE CONTROL KIT (K050983) | International Technidyne Corporation | 2005-05-16 |
| ARMAND ENDOSCOPE HOLDER (K050051) | KLS-Martin L.P. | 2005-05-16 |
| REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH (K043191) | Angiologica B. M. Srl | 2005-05-16 |
| NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE (K050594) | Nano-Ditech Co. | 2005-05-15 |
| MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM (K050093) | Ge Medical Systems Information Technologies | 2005-05-13 |
| KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM (K050130) | Kerberos Proximal Solutions, Inc. | 2005-05-13 |
| EVERLIFE (K050788) | Everlife Medical Instrument Co., Ltd. | 2005-05-13 |
| VITALWARE VMS (K050128) | Televital, Inc. | 2005-05-13 |
| FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM (K051025) | Hologic, Inc. | 2005-05-13 |
| EZ-STIK ELECTRODES (K050469) | Naimco, Inc. | 2005-05-13 |
| ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM (K051139) | Siemens Medical Solutions USA, Inc. | 2005-05-13 |
| BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7 (K050680) | OSTAR MEDITECH CORP. | 2005-05-13 |
| PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC (K050717) | CooperVision, Inc. | 2005-05-13 |
| ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES (K051076) | ZOLL Medical Corporation | 2005-05-13 |
| X-CHANGE (K051090) | Meyra | 2005-05-13 |
| RNA1C CONTROL FOR NYCOCARD HBA1C (K050961) | Bionostics, Inc. | 2005-05-13 |
| QUANTIA A1-AT (K050596) | Biokit, S.A. | 2005-05-13 |
| ESSENPACS (K051081) | Cymed Engineering, Inc. | 2005-05-12 |
| FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS (K050660) | First Quality Hygienic, Inc. | 2005-05-12 |
| STERRAD NX CHALLENGE PACK (K042450) | Advanced Sterilization Products | 2005-05-12 |
| BIO-RAD VARIANT NBS SICKLE CELL PROGRAM (K051072) | Bio-Rad Laboratories, Inc. | 2005-05-12 |
| MINILOC SAFETY INFUSION SET (K050600) | Specialized Health Products, Intl. | 2005-05-12 |
| BASIS SPINAL SYSTEM (K051039) | Medtronic Sofamor Danek USA, Inc. | 2005-05-12 |
| E.P.T. CERTAINTY PREGNANCY TEST (K050930) | Unipath , Ltd. | 2005-05-12 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML (K050881) | Becton, Dickinson & CO | 2005-05-12 |
| 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM (K050471) | Solco Biomedical Co., Ltd. | 2005-05-12 |
| SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 (K050503) | Olympus Medical Systems Corporation | 2005-05-12 |
| ARTHREX TAK FAMILY (K050749) | Arthrex, Inc. | 2005-05-12 |
| QUANTA PLEX ANCA PROFILE (K050715) | Inova Diagnostics, Inc. | 2005-05-12 |
| BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML (K050780) | Becton, Dickinson & CO | 2005-05-12 |
| ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM (K051083) | Acumed, LLC | 2005-05-12 |
| RAPID ONE STEP BUPRENORPHINE TEST CARD (K042988) | Tianjin New Bay Bioresearch Co., Ltd. | 2005-05-12 |
| VITEK 2 GRAM POSITIVE MEROPENEM (K050816) | bioMerieux, Inc. | 2005-05-12 |
| DELTON ILLUMINATING PIT AND FISSURE SEALING (K050959) | Dentsply International | 2005-05-11 |
| ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT (K041984) | Best Sanitizers, Inc. | 2005-05-11 |
| CZR PRESS LF STAINS (K050920) | Noritake Co., Inc. | 2005-05-11 |
| WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE (K043203) | Wilson-Cook Medical, Inc. | 2005-05-11 |
| AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS (K050252) | Masimo Corporation | 2005-05-11 |
| TRABECULAR METAL ACETABULAR REVISION SHELLS (K050937) | Zimmer Trabecular | 2005-05-11 |
| ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 (K050464) | Ultimed, Inc. | 2005-05-11 |
| MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE (K050071) | H.B.M. USA Co.,Inc. | 2005-05-11 |
| RADIOPAQUE BONE CEMENT (K043518) | Cardinalhealth | 2005-05-11 |
| MODIFICATION TO: MICROLIFE DIGITAL PACIFIER THERMOMETER, MODEL MT1751Q (K051100) | Microlife Intellectual Property GmbH | 2005-05-11 |
| ALUMINA HEAD (K050556) | Fournitures Hospitalieres Industrie | 2005-05-11 |
| NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 (K050720) | Integra Neurosciences | 2005-05-11 |
| HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM (K050892) | Blackstone Medical, Inc. | 2005-05-11 |
| RESSCAN (K050775) | Resmed, Ltd. | 2005-05-10 |
| PAINACEA MODEL XR8 INFRARED HEAT LAMP (K051046) | Atlantis Luminescent Products, LLC | 2005-05-10 |
| FOR SURE ONE STEP BUPRENORPHINE TEST STRIP (K042990) | Tianjin New Bay Bioresearch Co., Ltd. | 2005-05-10 |
| MARINA MEDICAL FINGER PROTECTORS (K042534) | Marina Medical Instruments, Inc. | 2005-05-10 |
| CARDIOMPO TEST (K050029) | Prognostix, Inc. | 2005-05-10 |
| LASIK EYE DRAPE (K042977) | Odyssey Medical, Inc. | 2005-05-10 |
| ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX (K043218) | Radiometer Medical Aps | 2005-05-10 |
| PAINPUMP2 (K043466) | Stryker Instruments | 2005-05-10 |
| PIONEER U121 SERIES CPAP (K041823) | Merits Health Products Co., Ltd. | 2005-05-10 |
| UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES (K050116) | Uniqsafe Biomeditech Co., Ltd. | 2005-05-09 |
| BARRIER SURGICAL GOWNS (K050786) | Molnlycke Health Care | 2005-05-09 |
| AMIGO INSULIN PUMP (K050312) | Nipro Diabetes Systems, Inc. | 2005-05-09 |
| TAG-IT CYSTIC FIBROSIS KIT (DEN050004) | Tm Bioscience Corporation | 2005-05-09 |
| URITEK 151 URINE ANALYZER, MODEL TC-151 (K042421) | Teco Diagnostics | 2005-05-09 |
| OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY (K050541) | Omniguide Communications, Inc. | 2005-05-09 |
| TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 (K050926) | Idev Technologies, Inc. | 2005-05-09 |
| ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE (K050593) | ACON Laboratories, Inc. | 2005-05-06 |
| ATRIUM ICAST COVERED STENT (K050814) | Atrium Medical Corp. | 2005-05-06 |
| NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM (K050829) | Conmed Integrated Systems (Cmis) | 2005-05-06 |
| SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) (K051052) | Galil Medical , Ltd. | 2005-05-06 |
| NON-STICK ELECTRODE (K043036) | Modern Medical Equipment Mfg., Ltd. | 2005-05-06 |
| DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES (K050835) | GE Healthcare | 2005-05-06 |
| PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT (K050119) | Beckman Coulter, Inc. | 2005-05-06 |
| VENTANA IMAGE ANALYSIS SYSTEM (K050012) | Tripath Imaging, Inc. | 2005-05-06 |
| ANTI-I.V. ENTERAL FEEDING SYSTEM (K043044) | Viasys Medsystems | 2005-05-06 |
| MERIT PRELUDE SHEATH INTRODUCER (K050962) | Merit Medical Systems, Inc. | 2005-05-06 |
| CONCENTRIC EMBOLIC PEARLS (K050470) | Concentric Medical, Inc. | 2005-05-06 |
| LASER SYS*STIM 540, MODEL ME 540 (K043586) | Mettler Electronics Corp. | 2005-05-06 |
| IMORGON ULTRASOUND PACS SOLUTIONS (K050736) | Sea Ridge Software, Inc. | 2005-05-05 |
| MEDX HOME (K050022) | Medx Electronics, Inc. | 2005-05-05 |
| ECC.O SYSTEM (K050890) | Dideco S.R.L. | 2005-05-05 |
| COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS (K041540) | Standard Textile Co., Inc. | 2005-05-05 |
| MODUS TITANIUM OSTEOSYNTHESIS SYSTEM (K050934) | Medartis, Inc. | 2005-05-05 |
| ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER (K050874) | Astra Tech, Inc. | 2005-05-05 |
| CYNOSUREA ECLILITE AND ECLILITE U (K050080) | Cynosure, Inc. | 2005-05-05 |