| ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE (K041946) | ACON Laboratories, Inc. | 2004-08-16 |
| ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H (K041194) | Medical Analysis Systems, Inc. | 2004-08-16 |
| 2 CM PERIPHERAL CUTTING BALOON (K041993) | Boston Scientific Ivt | 2004-08-16 |
| JMS BLOOD TUBING SETS (K032975) | Jms North America Corp. | 2004-08-16 |
| CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM (K041898) | Cliniqa Corporation | 2004-08-16 |
| G5 I HBA1C TEST, G5 II HBA1C TEST (K041635) | Provalis Diagnostics , Ltd. | 2004-08-16 |
| CYPRESS ULTRASOUND SYSTEM (K042055) | Siemens Medical Solutions USA, Inc. | 2004-08-16 |
| ACUSON CV70 CARDIOVASCULAR SYSTEM (K042044) | Siemens Medical Solutions USA, Inc. | 2004-08-13 |
| IMMUNOCARD STAT! RSV MODEL #750630 (K041445) | Meridian Bioscience, Inc. | 2004-08-13 |
| DENFIL (K042124) | Vericom Co., Ltd. | 2004-08-13 |
| DURALITE-GL (K041262) | Laser Scientific | 2004-08-13 |
| ARCHITECT STAT TROPONIN-I IMMUNOASSAY (K041192) | Fisher Diagnostics | 2004-08-12 |
| POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) (K040792) | Pt. Smartglove Indonesia | 2004-08-12 |
| POLYMEDCO OC LIGHT FOBT TEST (K041297) | Polymedco, Inc. | 2004-08-12 |
| POLYGRAM NET BIOFEEDBACK APPLICATION (K041244) | Medtronic Vascular | 2004-08-12 |
| HOVERJACK AIR PATIENT LIFT DEVICE (K041503) | D.T. Davis Enterprises , Ltd. | 2004-08-12 |
| SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 (K033027) | Shining World Health Care Co., Ltd. | 2004-08-12 |
| XPS CURVED BUR (K041985) | Medtronic Xomed, Inc. | 2004-08-12 |
| PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V (K032192) | Tuttnauer U.S.A Co, Ltd. | 2004-08-12 |
| MODIFICATION TO NC-STAT (K041320) | Neurometrix, Inc. | 2004-08-12 |
| HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST (K041202) | W.H.P.M., Inc. | 2004-08-12 |
| E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER (K042022) | Datrix, Inc. Dba of Jon Barron, Inc. | 2004-08-12 |
| HEALICOLL (K040314) | Encoll Corp. | 2004-08-12 |
| NUNC IVF MULTIDISH 4 WELLS NUNCLON (K040717) | Nunc A/S | 2004-08-12 |
| FLO-RITE (K041057) | Ameriflo Corp. | 2004-08-12 |
| SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING (K033843) | Cook, Inc. | 2004-08-12 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML (K041572) | Becton, Dickinson and Co. | 2004-08-12 |
| HANSON SCAR ADE (K040307) | Hanson Medical, Inc. | 2004-08-12 |
| MARK III PHASED ARRAY SHOULDER COIL (K042009) | Usa Instruments, Inc. | 2004-08-11 |
| SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS (K041948) | American Medical Systems, Inc. | 2004-08-11 |
| NEW BRID (K041780) | Medical Imaging Solutions, Inc. | 2004-08-11 |
| TERUMO CIRCUIT CONNECTORS (K041697) | Terumo Cardiovascular Systems Corporation | 2004-08-11 |
| HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE (K041728) | Immunostics Inc., | 2004-08-11 |
| ALCOMATE, MODEL CA2000 (K041334) | Khn Solutions, LLC | 2004-08-11 |
| MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 (K040745) | Concentric Medical, Inc. | 2004-08-11 |
| TEGO NEEDLE FREE ACCESS ACCESS DEVICE (K040710) | Icu Medical, Inc. | 2004-08-11 |
| MERCI RETRIEVER, MODELS 90065, 90066 (K033736) | Concentric Medical, Inc. | 2004-08-11 |
| ADVANCED D-DIMER ASSAY (K041438) | Dade Behring, Inc. | 2004-08-11 |
| EZ SMART (K040848) | Vip International Wholesalers, Corp. | 2004-08-11 |
| PEDIATRIC REFERENCE DATABASE (K041266) | Hologic, Inc. | 2004-08-11 |
| CURVED PEEK TETRIS SPINAL IMPLANT (K041888) | Signus Medizintechnik GmbH | 2004-08-10 |
| HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM (K040651) | Hommed, LLC | 2004-08-10 |
| ELEKTA OY (K041264) | Elekta Neuromag OY | 2004-08-10 |
| BINAXNOW INFLUENZA A & B TEST (K041049) | Binax, Inc. | 2004-08-10 |
| WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M (K041231) | Panbio Limited | 2004-08-10 |
| ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 (K032954) | Danmeter A/S | 2004-08-09 |
| EMG - ESSENTIAL GAS MODULE, MODEL M1013A (K041956) | Draeget Medical AG & Co. Kgaa | 2004-08-09 |
| VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE (K042028) | Zibo Borui Plastic & Rubber Products Co., Ltd. | 2004-08-09 |
| DELTA T (K041076) | Penlon , Ltd. | 2004-08-09 |
| MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K041197) | Medtronic Sofamor Danek | 2004-08-09 |
| PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR (K041831) | Progeny, Inc. | 2004-08-09 |
| VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART (K041953) | Conmedcorp | 2004-08-09 |
| STIMULEN COLLAGEN (K030774) | Southwest Technologies, Inc. | 2004-08-09 |
| ASTRA TECH IMPLANTS - DENTAL SYSTEM (K041492) | Astra Tech, Inc. | 2004-08-09 |
| SENTEC DIGITAL MONITOR MODEL #SDM (K041548) | Sentec, Inc. | 2004-08-09 |
| SECURVIEW DX SOFTCOPY WORKSTATION (K041555) | Hologic, Inc. | 2004-08-09 |
| AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) (K041748) | Azog, Inc. | 2004-08-09 |
| PERFORMANCE WATER TREATMENT SYSTEM (K033648) | Performance Water Systems, LLC | 2004-08-09 |
| RAVEN PROTEST - STEAM (K041386) | Raven Biological Laboratories, Inc. | 2004-08-09 |
| CRYOTIP (K041562) | Irvine Scientific Sales Co., Inc. | 2004-08-09 |
| STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM (K033135) | Stryker Endoscopy | 2004-08-09 |
| DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682 (K041827) | Boston Scientific Corp | 2004-08-06 |
| POLYURETHANE BLOOD PRESSURE CUFFS (K041689) | D. E. Hokanson, Inc. | 2004-08-06 |
| FINISHING WIRE SUPPORTRAK (K041762) | Guidant Corporation | 2004-08-06 |
| FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH (K032884) | Boston Scientific Epi | 2004-08-06 |
| PERMANENT PACING LEAD, MODEL PY2 (K041809) | Oscor, Inc. | 2004-08-06 |
| MSI S-500L RF GENERATOR (K041980) | Medsphere International, Inc. | 2004-08-06 |
| POWERHEART AED G3 PRO (K040637) | Cardiac Science, Inc. | 2004-08-06 |
| XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 (K040358) | Excel Tech. , Ltd. | 2004-08-06 |
| DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 (K042014) | Sein Electronics Co., Ltd. | 2004-08-06 |
| FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP (K041990) | Fujifilm Medical System U.S.A., Inc. | 2004-08-06 |
| C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS (K041434) | Analogic Corp. | 2004-08-06 |
| HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01 (K041504) | Haemacure Corp. | 2004-08-06 |
| LYSUS INFUSION SYSTEM (K041629) | Ekos Corp. | 2004-08-06 |
| LVI AESTHETIC LASER (K041721) | Hoya Photonics, Inc. | 2004-08-05 |
| TALUS OF VILEX (TOV) (K041289) | Vilex, Inc. | 2004-08-05 |
| KARMA SCOOTER, MODEL KS-747.2 (K041677) | Karma Medical Products Co., Ltd. | 2004-08-05 |
| NEXFLEX TOTAL HIP SYSTEM (K033580) | Nexmed, Inc. | 2004-08-05 |
| STURDY MANUAL RESUSCITATOR (K032596) | Sturdy Industrial Co., Ltd. | 2004-08-05 |
| ARTHREX FIBERWIRE WITH SILK (K041589) | Arthrex, Inc. | 2004-08-05 |
| ANTIMICROBIAL ALGINATE DRESSING (K041316) | Advanced Medical Solutions, Ltd. | 2004-08-05 |
| STRYKER SPINE VERTEBRAL SPACER (K040731) | Stryker Spine | 2004-08-05 |
| TEH LIN POWERED WHEELCHAIR, MDG-601 (K041752) | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004-08-05 |
| INFUSIONCATH (K041517) | Id, LLC | 2004-08-05 |
| VILEX BONE PLATE SYSTEM (K041287) | Vilex, Inc. | 2004-08-05 |
| PLASMAJET SYSTEM (K030819) | Plasma Surgical, Ltd. | 2004-08-05 |
| SILVERSEAL (K033587) | Noble Fiber Technologies | 2004-08-05 |
| CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT (K041691) | West Pharmaceutical Services, Inc. | 2004-08-05 |
| EVA TPN CONTAINER (K041415) | B.Braun Medical, Inc. | 2004-08-04 |
| ELECTRO (K041219) | Permobil AB | 2004-08-04 |
| HEMO-DOP (K041915) | Dwl Elektronische Systeme GmbH | 2004-08-04 |
| MODIFICATION TO: ON-BOARD IMAGER DEVICE (K041519) | Varian Medical Systems, Inc. | 2004-08-04 |
| GEODESIC EEG SYSTEM SERIES 100 (K033399) | Electrical Geodesics, Incorporated | 2004-08-04 |
| HES ULTRASONIC THERAPY APPLIANCE (K040798) | Hwang Sun Enterprise Co., Ltd. | 2004-08-04 |
| ULTRABIO (K033178) | Sonotech, Inc. | 2004-08-04 |
| PORE-SI BONE GRAFT SUBSTITUTE (K040082) | Apatech , Ltd. | 2004-08-04 |
| PROVISO (K041886) | Scientific Pharmaceuticals, Inc. | 2004-08-04 |
| TEMP F (K040343) | Novocol, Inc. | 2004-08-03 |
| NIGHTFORM (K041996) | Plastic Surgery Solutions, LLC | 2004-08-03 |
| NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 (K033685) | Medical Cv, Inc. | 2004-08-03 |