| MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE (K041437) | Terang Nusa Sdn Bhd | 2004-09-16 |
| ASPIREX - BONE MARROW ASPIRATE KIT (K041991) | Isotis Orthobiologics, Inc. | 2004-09-16 |
| ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM (K041663) | Wrightmedicaltechnologyinc | 2004-09-16 |
| EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED (K033634) | Centerpulse Orthopedics, Inc. | 2004-09-15 |
| CLS SPOTORNO STEM (K042249) | Zimmer Austin, Inc. | 2004-09-15 |
| EPITOME SYSTEM (K041206) | Gebauer Medizintechnik GmbH | 2004-09-15 |
| CD HORIZON SPINAL SYSTEM (K041862) | Medtronic Sofamor Danek | 2004-09-15 |
| POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES (K042214) | Shandong Perfect Plastic Co., Ltd. | 2004-09-15 |
| SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) (K042020) | Hutchinson Technology, Inc. | 2004-09-15 |
| DISPOSABLE MONITORING ELECTRODES (K041954) | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2004-09-15 |
| ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY (K042194) | Medtronic Vascular | 2004-09-15 |
| ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES (K042242) | Alden Optical Labs., Inc. | 2004-09-15 |
| MDI ORTHO (K042289) | Imtec Corp. | 2004-09-15 |
| VST3 (K040942) | Biowatch Medical, Inc. | 2004-09-15 |
| MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA (K042389) | Roche Diagnostics Corp. | 2004-09-14 |
| TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (K040392) | American I.V. Products, Inc. | 2004-09-14 |
| MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS (K041964) | Mediaid, Inc. | 2004-09-14 |
| SOMATOM SPIRIT (K042328) | Siemens Medical Systems, Inc. | 2004-09-14 |
| TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM (K041771) | Twin Star Medical, Inc. | 2004-09-14 |
| FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS (K041522) | Elekon Industries U.S.A., Inc. | 2004-09-14 |
| VITEK 2 GRAM NEGATIVE ERTAPENEM (K041982) | bioMerieux, Inc. | 2004-09-14 |
| MODIFICATION TO OPTICAL SEPARATOR SYSTEM (K041795) | Applied Medical Resources Corp. | 2004-09-14 |
| PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 (K040479) | Welch Allyn, Inc. | 2004-09-14 |
| MODIFICATION TO EPTFE GRAFT (K041528) | Vascutek, Ltd. | 2004-09-14 |
| DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K042157) | Oxoid , Ltd. | 2004-09-14 |
| ZOE FLUID STATUS MONITOR (K042113) | Noninvasive Medical Technologies, LLC | 2004-09-14 |
| EP-4 CLINICAL STIMUTATOR (K041442) | Ep Medsystems | 2004-09-14 |
| LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX (K032991) | Light Age, Inc. | 2004-09-14 |
| ATRIUM MEDICAL CORPORATION ICAST COVERED STENT (K041269) | Atrium Medical Corp. | 2004-09-14 |
| RAVEN PROTEST - EO (K041784) | Raven Biological Laboratories, Inc. | 2004-09-13 |
| MONORAIL (K040143) | Nats Corp. | 2004-09-13 |
| LITEPORT LP100 SURGICAL ILLUMINATOR (K041621) | Medical Vision Industries, Inc. | 2004-09-13 |
| SAFE T RETRACTABLE BLOOD COLLECTION DEVICE (K041941) | Safe T Medical Devices, Ltd. | 2004-09-13 |
| DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER (K041694) | Hangzhou Hua'An Medical & Health Instruments Co., | 2004-09-13 |
| INFRARED EAR THERMOMETER, ET-100 SERIES (K041692) | Hangzhou Hua'An Medical & Health Instruments Co., | 2004-09-13 |
| 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (K041791) | Chf Solutions, Inc. | 2004-09-10 |
| EXACTECH 12/14 TOTAL HIP SYSTEM (K041906) | Exactech, Inc. | 2004-09-10 |
| INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 (K042262) | Sequal Technologies, Inc. | 2004-09-10 |
| ABBOTT AXSYM TROPONIN-I ADV (K041811) | Abbott Laboratories | 2004-09-10 |
| FACT PLUS ONE-STEP PREGNANCY TEST KIT (K042280) | Unipath , Ltd. | 2004-09-10 |
| BD FACSCANTO SYSTEM (K040725) | Becton Dickinson Immunocytometry Systems | 2004-09-10 |
| GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) (K041285) | Gyrus Medical , Ltd. | 2004-09-10 |
| QUICKSCREEN, MODELS 9177X AND 9178X (K041578) | Phamatech | 2004-09-10 |
| PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE (K040178) | S.P.O. Medical Equipment, Ltd. | 2004-09-10 |
| HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N (K041867) | Hygia Health Services, Inc. | 2004-09-10 |
| CHIN-UP STRIP (K040491) | Dale Miller, Inc. - the Chin-Up Company | 2004-09-10 |
| TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502 (K042202) | Oriental System Technology, Inc. | 2004-09-10 |
| SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS (K033341) | Smith & Nephew, Inc. | 2004-09-10 |
| BD FACS 7-COLOR SETUP BEADS (K040026) | Becton Dickinson Immunocytometry Systems | 2004-09-10 |
| MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT (K041381) | Medtronic Xomed, Inc. | 2004-09-10 |
| ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 (K042225) | Acmi Corporation | 2004-09-10 |
| VARILITE LASER SYSTEM (K041930) | Iridex Corporation | 2004-09-10 |
| SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007) (K042294) | Suiter Enterprises, Inc. | 2004-09-10 |
| BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 (K042026) | C.R. Bard, Inc. | 2004-09-10 |
| HAUSTED POWERTRAN SERIES STRETCHER (K041924) | STERIS Corporation | 2004-09-09 |
| CRANIAL HELMET (K041215) | Otto Bock Healthcare LP | 2004-09-09 |
| STERITEC EMU-GRAPH, MODEL NO. CI 131/US (K040901) | Steritec Products, Inc. | 2004-09-09 |
| PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES (K042213) | Shandong Perfect Plastic Co., Ltd. | 2004-09-09 |
| PACSPARTNER (K042311) | Medical Standard Co., Ltd. | 2004-09-09 |
| M.L. PRIMER (K040079) | Shofu Dental Corp. | 2004-09-09 |
| CADDY (K041186) | Afikim Electric Vehicles | 2004-09-09 |
| VISULAS YAG III (K042139) | Carl Zeiss Meditec, AG | 2004-09-09 |
| ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST (K042151) | ACON Laboratories, Inc. | 2004-09-09 |
| THE VITROS 5,1 FS CHEMISTRY SYSTEM (K041764) | Ortho-Clinical Diagnostics | 2004-09-09 |
| INTEGRADWEB MPR/MIP (K042313) | Dynamic Imaging, Inc. | 2004-09-09 |
| PREMICATH, 1261.205 (K041468) | Vygon Corp. | 2004-09-09 |
| ACON TRI-FECT DRUG SCREEN TEST DEVICE (K041743) | ACON Laboratories, Inc. | 2004-09-09 |
| RANDOX TRI LEVEL CARDIAC CONTROL (K041361) | Randox Laboratories Limited | 2004-09-09 |
| TRANSLUX POWER BLUE (K042199) | Heraeus Kulzer,GmbH | 2004-09-08 |
| VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS (K040662) | Chattanooga Group | 2004-09-08 |
| BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) (K041655) | Cowellmedi Co., Ltd. | 2004-09-08 |
| DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F (K042013) | Mesure Technology Co., Ltd. | 2004-09-08 |
| CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251 (K042304) | Spectris Technologies, Inc. | 2004-09-08 |
| DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION (K042257) | General Electric Co. | 2004-09-08 |
| DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9 (K041516) | Vega Technologies, Inc. | 2004-09-08 |
| SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM (K042136) | Sanarus Medical, Inc. | 2004-09-08 |
| SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP (K041611) | Synthes (Usa) | 2004-09-08 |
| MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) (K042128) | Zargis Medical Corp. | 2004-09-08 |
| HOFFMANN II FOOT RING (K041706) | Howmedica Osteonics Corp. | 2004-09-08 |
| ISITE PACS (K042292) | Stentor, Inc. | 2004-09-08 |
| SCANDIUS ACL RECONSTRUCTION SYSTEM (K041749) | Scandius Biomedical, Inc. | 2004-09-08 |
| TROCHANTERIC NAIL SYSTEM (K042325) | DePuy Orthopaedics, Inc. | 2004-09-08 |
| SYNTHES (USA) LCP CURVED PLATES (K041911) | Synthes (Usa) | 2004-09-08 |
| BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER (K042293) | Philips Medical Systems (Cleveland), Inc. | 2004-09-08 |
| MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET (K042234) | Specialty Health Products, Inc. | 2004-09-08 |
| CALCAMEA PLATE (K041786) | New Deal, S.A. | 2004-09-08 |
| BIOSOMNIA-V3 (K042309) | Oxford Biosignals Limited | 2004-09-08 |
| SYNERGY ULTIMATE (K041346) | Pride Mobility Products Corp. | 2004-09-08 |
| NUMELOCK II SYSTEM (K041709) | Howmedica Osteonics Corp. | 2004-09-08 |
| SONOSURG ULTRASONIC SURGICAL SYSTEM (K041566) | Aomori Olympus Co., Ltd. | 2004-09-08 |
| LTD POLYAXIAL FIXATION SYSTEM (K041625) | Us Spinal Technologies, LLC | 2004-09-08 |
| X-SIZER CATHETER SYSTEM (K021096) | Ev3 Corporation | 2004-09-08 |
| SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG (K041860) | Synthes (Usa) | 2004-09-08 |
| ARTHREX HUMERAL FRACTURE PLATES AND SCREWS (K041965) | Arthrex, Inc. | 2004-09-08 |
| LEKSELL GAMMAPLAN 4C WITH MULTIVIEW (K042269) | Elekta Instrument AB | 2004-09-08 |
| TRIMEDYNE HOLMIUM LASER SYSTEMS (K041660) | Trimedyne, Inc. | 2004-09-08 |
| BIOBLANKET (K041923) | Kensey Nash Corp. | 2004-09-08 |
| ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS (K041872) | Biomet Manufacturing Corp | 2004-09-08 |
| EXPEDIUM MIS SPINE SYSTEM (K041801) | Depuy Spine, Inc. | 2004-09-08 |
| AURA CPAP PATIENT INTERFACE (K042130) | Aeiomed, Inc. | 2004-09-08 |