| MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) (K041125) | Masep Med Science & Tech. Development (Shenzhen) C | 2004-12-30 |
| CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K042221) | Barco NV Barcoview | 2004-12-30 |
| VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM (K043230) | bioMerieux, Inc. | 2004-12-30 |
| BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET (K033210) | Bioteque Corp. | 2004-12-30 |
| MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE (K043397) | Becton, Dickinson & CO | 2004-12-29 |
| DISPOSABLE NON-ADHESIVE SPO2 SENSORS (K042705) | Elekon Industries U.S.A., Inc. | 2004-12-29 |
| TITANIUM MESH IMPLANT (K041407) | Interpore Cross Intl. | 2004-12-29 |
| VISIOPLAST ACRYLIC RESIN (K042414) | Tecres | 2004-12-29 |
| DIFOTI USB 2.0 SYSTEM (K043068) | Electro-Optical Sciences, Inc. | 2004-12-29 |
| FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 (K042713) | Spine Next America Corporation | 2004-12-29 |
| MODIFICATION TO: ZILVER 635 BILIARY STENT (K043481) | Cook, Inc. | 2004-12-29 |
| ACUPUNCTURE NEEDLES (K041652) | C.A.I. Industries Corp. | 2004-12-29 |
| PEDIGUARD NERVE DETECTOR SYSTEM (K030526) | Spine Vision, Inc. | 2004-12-29 |
| DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT (K043378) | Drew Scientific , Ltd. | 2004-12-29 |
| PMP4 OXY PRO (K043162) | Card Guard Scientific Survival , Ltd. | 2004-12-29 |
| MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K043561) | Medtronic Sofamor Danek | 2004-12-29 |
| ONLINE DAT BARBITURATES PLUS (K043211) | Roche Diagnostics Corp. | 2004-12-29 |
| WATCH PAT 100S (K042916) | Itamar Medical | 2004-12-29 |
| FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4 (K042714) | Spine Next America Corporation | 2004-12-29 |
| AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II (K042975) | Ameditech, Inc. | 2004-12-29 |
| PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X (K043167) | Phamatech, Inc. | 2004-12-29 |
| CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 (K042381) | Acumen Medical, Inc. | 2004-12-28 |
| CAPSULE TENSION RING INSERTER, MODEL 7-810 (K042478) | Duckworth & Kent, Ltd. | 2004-12-28 |
| SPACEVISION CAGE SYSTEM (K042930) | Spine Vision, Inc. | 2004-12-28 |
| MODIFICATION TO: CD HORIZON SPINAL SYSTEM (K043343) | Medtronic Sofamor Danek | 2004-12-28 |
| CEMEX SYSTEM GENTA FAST BONE CEMENT (K043403) | Exactech, Inc. | 2004-12-28 |
| HERBERT ULNAR HEAD PROSTHESIS SYSTEM (K042902) | Stuckenbrock Medizintechnik GmbH | 2004-12-27 |
| CLINICAL ELECTRONIC THERMOMETER (K032434) | Cotronic Manufacturing | 2004-12-27 |
| MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 (K042362) | Diagnostic Chemicals , Ltd. | 2004-12-27 |
| UNICRYL (K042288) | United Medical Industries Co. , Ltd. | 2004-12-27 |
| CEMENTEK LV (K042911) | Teknimed, S.A. | 2004-12-27 |
| GLUCOSE OXIDASE, GLUCOSE (K040974) | Genchem, Inc. | 2004-12-27 |
| GENCHEM ELECTROLYTE BUFFER (K040977) | Genchem, Inc. | 2004-12-27 |
| MODIFICATION TO T2 PROXIMAL HUMERAL NAIL (K043404) | Howmedica Osteonics Corp. | 2004-12-27 |
| CALCIUM, AZO DYE REAGENT (K040972) | Genchem, Inc. | 2004-12-27 |
| PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 (K042947) | Arthrocare Corp. | 2004-12-27 |
| SALICYLATE-SL ASSAY (K042329) | Diagnostic Chemicals , Ltd. | 2004-12-27 |
| GENCHEM CREATININE REAGENT (K040976) | Genchem, Inc. | 2004-12-27 |
| GENCHEM CO2 ACID REAGENT (K040975) | Genchem, Inc. | 2004-12-27 |
| BUN REAGENT (K040973) | Genchem, Inc. | 2004-12-27 |
| SURGPLAN AND PANPLAN (K041078) | Imaging Sciences Intl., Inc. | 2004-12-23 |
| LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER (K043241) | Astra Tech, Inc. | 2004-12-23 |
| OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 (K043202) | Olympus America, Inc. | 2004-12-23 |
| TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) (K040778) | Tanita Corp. of America | 2004-12-23 |
| VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN (K043237) | bioMerieux, Inc. | 2004-12-23 |
| SOMATOM RESPIRATORY GATING (K043086) | Siemens Medical Solutions USA, Inc. | 2004-12-23 |
| AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM (DEN040012) | Affymetrix, Inc. | 2004-12-23 |
| INFINIA LIGHTSPEED (K043381) | Ge Medical Systems F.I. Haifa | 2004-12-23 |
| LTU-904 PORTABLE LASER THERAPY UNIT (K030295) | Riancorp Pty, Ltd. | 2004-12-23 |
| MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY (K043318) | Roche Diagnostics Corp. | 2004-12-23 |
| SONATA 3-D IMAGING ACCESSORY, MODEL 3DS (K042620) | Tetrad Corp. | 2004-12-23 |
| AMPLICHIP CYP450 TEST, MODEL 04381866190 (DEN040011) | Roche Molecular Systems, Inc. | 2004-12-23 |
| DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE (K043276) | Datex-Ohmeda | 2004-12-23 |
| MTF ALLOGRAFT ANCHOR (K042038) | Musculoskeletal Transplant Foundation | 2004-12-23 |
| FEMSPEC DISPOSABLE VAGINAL SPECULUM (K041757) | Femspec LLC | 2004-12-23 |
| LIFESTENT NT35 BILIARY STENT SYSTEM (K042985) | Edwards Lifesciences, LLC | 2004-12-23 |
| EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS (K043090) | Phonic Ear, Inc. | 2004-12-23 |
| DEPUY C-STEM AMT HIP PROSTHESIS (K042959) | DePuy Orthopaedics, Inc. | 2004-12-22 |
| HEMOSIL RECOMBIPLASTIN (K043184) | Instrumentation Laboratory CO | 2004-12-22 |
| GE OEC FLUOROSTAR (K043076) | Ge Oec Medical Systems, Inc. | 2004-12-22 |
| HEALTHSTAR ELITE (K043239) | Hill Laboratories Co. | 2004-12-22 |
| Lysus Infusion System (K043269) | Ekos Corp. | 2004-12-22 |
| GORE POLYPROPYLENE HERNIA MESH (K043081) | W. L. Gore & Associates, Inc. | 2004-12-22 |
| EAR THERMOMETER, MODEL WL-320X (K042631) | Innovatech, Inc. | 2004-12-22 |
| ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM (K043158) | Bayer Healthcare, LLC | 2004-12-22 |
| PEFAKIT APC-R FACTOR V LEIDEN (K042762) | Pentapharm , Ltd. | 2004-12-22 |
| GENCHEM ISE ELECTROLYTE REFERENCE (K040971) | Genchem, Inc. | 2004-12-22 |
| ARCHITECT CA 15-3 ASSAY (K042732) | Fujirebio Diagnostics,Inc. | 2004-12-22 |
| PEFAKIT APC-R FACTOR V LEIDEN CONTROLS (K042760) | Pentapharm , Ltd. | 2004-12-22 |
| GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (K043056) | W. L. Gore & Associates, Inc. | 2004-12-22 |
| GYNECARE PROLENE FASTENER SYSTEM (K042603) | ETHICON, Inc. | 2004-12-22 |
| BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML (K043038) | Biotop Technology Co., Ltd. | 2004-12-22 |
| TCM ENDO V, MODEL 1534 (K042822) | NOUVAG AG | 2004-12-22 |
| NEOSCI MEDICAL ENDOLUMINAL BRUSH (K030400) | Neosci Medical, Inc. | 2004-12-22 |
| ASCENSIA ELITE DIABETES CARE SYSTEM (K043311) | Bayer Healthcare, LLC | 2004-12-22 |
| PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP (K043272) | Kendall | 2004-12-22 |
| 12-LEAD GLOVE (K033559) | Ineedmd | 2004-12-22 |
| NEEDLE INCAPACITATOR (NEEDLE GUARD) (K042907) | Pdmp, Inc. | 2004-12-22 |
| QUANTEX MYOGLOBIN (K042982) | Instrumentation Laboratory CO | 2004-12-22 |
| DUCERA ALLCERAM (K043247) | Dentsply Intl. | 2004-12-22 |
| LUTH-ALL SUB-Q NEEDLE SET (K042666) | Luth-All Medical Products, LLC | 2004-12-21 |
| TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 (K042871) | Zimmer Trabecular | 2004-12-21 |
| TRABECULAR METAL KNEE SYSTEM AUGMENTS (K040487) | Implex Corp. | 2004-12-21 |
| NOVASYS TRANSURETHRAL RF SYSTEM (K042132) | Novasys Medical, Inc. | 2004-12-21 |
| UNIVERSAL XACTTRACE (K043132) | Medcare Flaga | 2004-12-21 |
| MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS (K042000) | Msq (M2) , Ltd. | 2004-12-21 |
| UCR SPINAL SYSTEM (K043232) | Seaspine | 2004-12-21 |
| TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM (K043452) | Sonosite,Inc. | 2004-12-21 |
| MODIFICATION TO: PLEXALONG SETS (K042979) | Pajunk GmbH | 2004-12-21 |
| ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM (K042825) | Integra LifeSciences Corporation | 2004-12-21 |
| THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 (K043482) | STERIS Corporation | 2004-12-21 |
| MEDALLION MODULAR HIP SYSTEM (K041850) | Biomet Manufacturing, Inc. | 2004-12-21 |
| VERTEX RECONSTRUCTION SYSTEM (K042789) | Medtronic Sofamor Danek | 2004-12-21 |
| MODIFICATION TO ALTIUS OCT SYSTEM (K043229) | Interpore Cross Intl. | 2004-12-21 |
| APEX K2 HIP SYSTEM (K041950) | Apex Surgical, LLC | 2004-12-21 |
| MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS (K043130) | Pajunk GmbH | 2004-12-21 |
| SERFAS ENERGY SYSTEM (K041810) | Stryker Endoscopy | 2004-12-21 |
| CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 (K043291) | Medtronic Vascular | 2004-12-21 |
| M2A/C2A ACETABULAR SYSTEM (K042841) | Biomet, Inc. | 2004-12-21 |
| DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER (K033044) | American Green Dent. Mfg, Inc. | 2004-12-21 |