| DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE (K071889) | GE Healthcare | 2008-05-19 |
| MODIFICATION TO 3M TEGADERM CHG DRESSING (K080620) | 3M Company-3M Health Care | 2008-05-19 |
| POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (K072300) | Perusahaan Pelindung Getah (M) Sdn Bhd | 2008-05-16 |
| REACTIVE DENTAL IMPLANT SYSTEM (K080713) | Implant Direct, LLC | 2008-05-16 |
| DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA (K080578) | Siemens Healthcare Diagnostics, Inc. | 2008-05-16 |
| SHUNTCHECK - CSF SHUNT FLOW DETECTOR (K080168) | Neuro Diagnostic Devices | 2008-05-16 |
| BI-RADS COMPANION (K072258) | Almen Laboratories, Inc. | 2008-05-16 |
| SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM (K081110) | Shantou Institute of Ultrasonic Instuments | 2008-05-16 |
| MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM (K080029) | Mako Surgical Corp. | 2008-05-16 |
| T34L SYRINGE DRIVER (K080954) | Caesarea Medical Electronics , Ltd. | 2008-05-16 |
| FMRI HARDWARE SYSTEM (K080515) | Nordicneurolab | 2008-05-16 |
| AUTO-BAND LIGATOR (K081142) | Scandimed International | 2008-05-16 |
| SUBDERMAL NEEDLE ELECTRODES (K072276) | Xian Friendship Electronics Co., Ltd. | 2008-05-16 |
| DIO BIOTITE-H IMPLANT SYSTEM (K073070) | Dio Department Dsi, Inc. | 2008-05-16 |
| SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE (K080439) | Mallinckrodt Developpement France | 2008-05-16 |
| AMPLATZER TORQVUE EXCHANGE SYSTEM (K080994) | Aga Medical Corp. | 2008-05-16 |
| GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS (K071512) | ETHICON, Inc. | 2008-05-15 |
| ECHELON TITANIUM HIP SYSTEM (K072817) | Smith & Nephew, Inc. | 2008-05-15 |
| BIOSYAG MEDICAL SYSTEM (K080374) | Bios S.R.L. | 2008-05-15 |
| ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM (K080227) | Roche Diagnostics Corp. | 2008-05-15 |
| MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA (K080582) | Medicatech USA | 2008-05-15 |
| OSTEOMED MODULAR LOCKING FIXATION SYSTEM (K080694) | Osteomed LP | 2008-05-15 |
| PROFEMUR LX 5/8 COATED HIP STEM (K081090) | Wrightmedicaltechnologyinc | 2008-05-15 |
| ZIRDENT CAD/CAM BLOCKS (K081253) | C5 Medical Werks, Inc. | 2008-05-15 |
| MODIFICATION TO VIPER SPINE SYSTEM (K073562) | Depuy Spine, Inc. | 2008-05-15 |
| IB NEURO, VERSION 1.0 (K080762) | Imaging Biometrics, LLC | 2008-05-15 |
| PEEK PREVAIL CERVICAL INTERBODY DEVICE (K073285) | Medtronic Sofamor Danek USA, Inc. | 2008-05-15 |
| GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR (K080662) | Genzyme Corporation | 2008-05-15 |
| PLATEAU SPACER SYSTEM (K080411) | Life Spine | 2008-05-15 |
| COLLAGEN TENDON WRAP (K080452) | Collagen Matrix, Inc. | 2008-05-15 |
| EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE (K080587) | Animas Corp. | 2008-05-15 |
| HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING (K080818) | Hem Con Medical Technologies, Inc. | 2008-05-15 |
| MPS ACACIA ENTERAL FEEDING TUBE (K080328) | Mps Acacia | 2008-05-14 |
| HEARTRAK AF (K071130) | Universal Medical, Inc. | 2008-05-14 |
| SMARTSET GMV GENTAMICIN BONE CEMENT (K081163) | DePuy Orthopaedics, Inc. | 2008-05-14 |
| COLORISE RIGID (K081084) | Zhermack S.P.A. | 2008-05-14 |
| SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY) (K080165) | Platinum Glove Industries Sdn. Bhd. | 2008-05-14 |
| SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION (K080701) | Shimadzu Corp. | 2008-05-14 |
| SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM (K080153) | Synthes (Usa) | 2008-05-14 |
| INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C (K080769) | Somanetics Corp. | 2008-05-14 |
| STYLA MICROLASER AND STYLAORTHO (K081214) | Zap Lasers, LLC | 2008-05-14 |
| SMARTSET MV BONE CEMENT (K081155) | DePuy Orthopaedics, Inc. | 2008-05-14 |
| SM-EXTRA WIDE (RBM) IMPLANT SYSTEM (K080128) | Dio Department Dsi, Inc. | 2008-05-14 |
| REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) (K081341) | Thomas Medical Products, Inc. | 2008-05-14 |
| 3 CCD ENDOCAM 5550 (K080977) | Richard Wolf Medical Instruments Corp. | 2008-05-14 |
| CPAP MASK (K071915) | Arcimed Laboratories, LLC | 2008-05-14 |
| CONCEIVEX LATEX-FREE SEMEN COLLECTOR (K080752) | Conceivex, Inc. | 2008-05-14 |
| INCLUSIVE IMPLANT ABUTMENTS (K073217) | Inclusive Dental Solutions | 2008-05-14 |
| SIALO BALLOON DILATATION CATHETER (K072749) | Sialo Technology, Ltd. | 2008-05-14 |
| CALYPSO 4D LOCALIZATION SYSTEM (K080726) | Calypso Medical Technologies, Inc. | 2008-05-14 |
| EASY GRIP DENTAL IMPLANT SYSTEM (K073622) | T.F.I. System S.R.L | 2008-05-14 |
| GRADUATED ADAPTER WITH CLAVE (K080007) | Icu Medical, Inc. | 2008-05-13 |
| ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT (K080400) | AngioDynamics, Inc. | 2008-05-13 |
| DENTRON SENSOR (K080738) | Dentron Systems, LLC | 2008-05-13 |
| LEKSELL SURGIPLAN, MODEL 1006947 (K080250) | Elekta Instrument AB | 2008-05-13 |
| CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR (K080385) | E1 Ent., Inc. | 2008-05-13 |
| PROGENIX DBM PUTTY (K080462) | Medtronic Sofamor Danek | 2008-05-13 |
| OSTEOTRANS-OT SCREW (K073312) | Takiron Co., Ltd. | 2008-05-13 |
| NOVOLET (K080665) | U.S. Safety Syringes Co., Inc. | 2008-05-13 |
| PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM (K073177) | Pioneer Surgical Technology | 2008-05-13 |
| CORRIDOR4DM (K080575) | Invia | 2008-05-13 |
| MODIFICATION TO AESKULISA DS DNA G (K081251) | Aesku Diagnostics | 2008-05-13 |
| IV ADMINISTRATION SET (K080660) | U.S. Safety Syringes Co., Inc. | 2008-05-13 |
| OSTEOTRANS-OT PIN (K073311) | Takiron Co., Ltd. | 2008-05-13 |
| DURAFINISH ALL-CURE, MODEL S296 (K080549) | Parkell, Inc. | 2008-05-13 |
| LITEDUO (K073411) | Light Instruments | 2008-05-13 |
| MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D (K080337) | Microlife Corp. | 2008-05-13 |
| SPINAL USA INTERBODY FUSION DEVICE (K080314) | Spinal USA | 2008-05-13 |
| REVOLUTION 45MHZ IVUS IMAGING CATHETER (K080891) | Volcano Corporation | 2008-05-12 |
| DORIPENEM 10UG BBL SENSI-DISC (K080998) | Becton, Dickinson & CO | 2008-05-12 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 (K080607) | Roche Diagnostics Corp. | 2008-05-12 |
| CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS (K080936) | Conformis, Inc. | 2008-05-12 |
| CAPSURE PS (R) SPINE SYSTEM (K081228) | Spine Wave, Inc. | 2008-05-12 |
| BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR (K080750) | STERIS Corporation | 2008-05-12 |
| THERMOFLASH LX-26 (K080759) | Jxb Co. Ltd Guangzhou (China) | 2008-05-12 |
| MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER (K080238) | Masimo Corporation | 2008-05-12 |
| TUTODENT DENTAL MEMBRANE (K073097) | Tutogen Medical U.S., Inc. | 2008-05-12 |
| OMNI-TIGHT (K072595) | Basic Dental Implant Systems, Inc. | 2008-05-09 |
| GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) (K081105) | GE Healthcare | 2008-05-09 |
| KSEA CLEARVISION II, MODEL 40334120 (K072410) | KARL STORZ Endoscopy-America, Inc. | 2008-05-09 |
| PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS (K073477) | Photonova Ofsweden AB | 2008-05-09 |
| LEICA FL800 (K080612) | Leica Microsystems (Schweiz) AG | 2008-05-09 |
| WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV (K080177) | Nihon Seimitsu Sokki Co., Ltd. | 2008-05-09 |
| SOYALA GEL VENTED (K081014) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2008-05-09 |
| MAMMOSITE CAVITY EVALUATION DEVICE (K081179) | Hologic, Inc. | 2008-05-09 |
| FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) (K081067) | Biomet Microfixation, Inc. | 2008-05-09 |
| PAGEWRITER CARDIOGRAPH (K080999) | Philips Medical Systems | 2008-05-09 |
| METHA SHORT STEM HIP SYSTEM (K080584) | Aesculap Implant System, Inc. | 2008-05-09 |
| SHELL CAGE, WAVE CAGE, LOOP CAGE (K080401) | Advanced Medical Technologies AG | 2008-05-09 |
| OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS (K080187) | Olsen Medical | 2008-05-09 |
| PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM (K080674) | PAJUNK GmbH Medizintechnologie | 2008-05-09 |
| EVOLUTION ESOPHAGEAL STENT SYSTEM (K080359) | Cook Ireland, Ltd. | 2008-05-09 |
| ALCON VISION SYSTEM (K063583) | Alcon | 2008-05-09 |
| 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) (K081036) | Varian Medical Systems, Inc. | 2008-05-09 |
| PULMODYNE CHF FLOW GENERATOR SYSTEM (K080256) | Pulmodyne | 2008-05-09 |
| CHRYSALIS (K080655) | Meta Imaging Solutions, LLC | 2008-05-09 |
| AXXENT VAGINAL APPLICATOR (K072616) | Xoft, Inc. | 2008-05-09 |
| LAURIMED SPINAL INJECTION SYSTEM (K080140) | Laurimed, LLC | 2008-05-09 |
| VERISUITE 1.6, VERISUITE-PARTICLE 1.6 (K080742) | Medcom GmbH | 2008-05-09 |
| ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT (K080202) | Oncobionics, Inc. | 2008-05-08 |