| ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 (K070417) | St Jude Medical | 2007-06-05 |
| AURALAY PIT & FISSURE SEALANT (K071158) | Denali Corporation | 2007-06-05 |
| GENIE, MODEL CH-200 (K070633) | Icu Medical, Inc. | 2007-06-05 |
| ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL (K060434) | Horiba Abx | 2007-06-05 |
| ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV (K071249) | ETHICON, Inc. | 2007-06-05 |
| UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) (K071462) | Siemens Hearing Instruments, Inc. | 2007-06-05 |
| DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 (K070878) | Rg Medical Diagnostics | 2007-06-05 |
| AMARIS/AMARIS FLOW (K071386) | Voco GmbH | 2007-06-05 |
| 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS (K070951) | Boston Scientific | 2007-06-04 |
| SUNMED FOLEY CATHETERS (K062112) | Sunmed, Inc. | 2007-06-04 |
| OLYMPUS CK-MB REAGENT (K070835) | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-04 |
| INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL (K070566) | Draeger Medical Systems, Inc. | 2007-06-04 |
| IMDX SYSTEMS (K063699) | Novx Systems, Inc. | 2007-06-01 |
| TRIATHLON TS KNEE SYSTEM (K070095) | Howmedica Osteonics Corp. | 2007-06-01 |
| GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610 (K070372) | Vascular Solutions, Inc. | 2007-06-01 |
| SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS (K071280) | Beckman Coulter, Inc. | 2007-06-01 |
| REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (K071358) | Radiant Medical | 2007-06-01 |
| ARTELON CMC SPACER ARTHRO (K061954) | Artimplant AB | 2007-06-01 |
| RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0 (K071086) | Calgary Scientific, Inc. | 2007-06-01 |
| VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 (K070991) | Vita | 2007-06-01 |
| SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (K070939) | Coloplast Manufacturing Us, LLC | 2007-06-01 |
| SYNCHRON SYSTEMS CREATININE REAGENT (K071283) | Beckman Coulter, Inc. | 2007-06-01 |
| COLUMBUS TOTAL KNEE SYSTEM AS (K071220) | Aesculap Implant Systems, Inc. | 2007-06-01 |
| OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS (K062636) | Implant Innovations, Inc. | 2007-06-01 |
| MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR (K071246) | Micrus Endovascular Corporation | 2007-06-01 |
| BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER (K070864) | Biomet Osteobiologics | 2007-06-01 |
| COPIOS BONE VOID FILLER SPONGE AND PASTE (K071237) | Kensey Nash Corp. | 2007-06-01 |
| SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS (K071277) | Beckman Coulter, Inc. | 2007-06-01 |
| ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE (K071206) | Apatech , Ltd. | 2007-05-31 |
| IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL (K070716) | KARL STORZ Endoscopy-America, Inc. | 2007-05-31 |
| SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES (K062149) | International Business Strategies | 2007-05-31 |
| LUBRINA, MODEL HIM-1 (K070074) | J. Morita USA, Inc. | 2007-05-31 |
| VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS (K071193) | Vidar Systems Corp. | 2007-05-30 |
| DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK (K070692) | Dukal Corporation | 2007-05-30 |
| SBI DISTAL RADIUS VOLAR PLATING SYSTEM (K070793) | Small Bone Innovations, Inc. | 2007-05-30 |
| POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE) (K070862) | Purtech Cleanroom Products Co., Ltd. | 2007-05-30 |
| DIRECT DIGITIZER, REGIUS MODEL 110 (K071181) | Konica Minolta Medical & Graphic, Inc. | 2007-05-30 |
| MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP (K070814) | Confluent Surgical,Inc | 2007-05-30 |
| VISTA -S DEVICE (K070382) | Zimmer Trabecular Metal Technology | 2007-05-30 |
| THYROSAMPLER (K062979) | Acd Medical Innovation Corp. | 2007-05-30 |
| VITAL CONNECT 4.1 (K071362) | Vital Images, Inc. | 2007-05-30 |
| MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE (K071185) | Ambu A/S | 2007-05-30 |
| CARDIOMEM CM 3000-12BT (K063042) | Getemed Medizin- Und Informationstechnik AG | 2007-05-30 |
| THEKEN ATOLL CERVICO-THORACIC SYSTEM (K070638) | Theken Spine, LLC | 2007-05-30 |
| OSSTAPLE, OSSPLATE, OSSFORCE (K061385) | Biomedical Enterprises, Inc. | 2007-05-30 |
| ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 (K071235) | Zimmer Dental, Inc. | 2007-05-30 |
| ARAGON SURGICAL LAPCAP (K070651) | Aragon Surgical, Inc. | 2007-05-30 |
| EVICEL APPLICATION DEVICE (K070575) | Omrix Biopharmaceuticals , Ltd. | 2007-05-29 |
| AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES (K062823) | Alpha-Omega Services, Inc. | 2007-05-29 |
| FLEX ARM RETRACTOR SYSTEM (K071338) | Koros USA, Inc. | 2007-05-29 |
| ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 (K062025) | Corgenix, Inc. | 2007-05-29 |
| NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP (K070416) | Neoforce Group, Inc. | 2007-05-29 |
| 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB (K070264) | Terumo Europe N.V. | 2007-05-29 |
| LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR (K070825) | Little Doctor (Shanghai) Electronic Manufacturing | 2007-05-25 |
| INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES (K071222) | Baxter Healthcare Corp | 2007-05-25 |
| ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM (K061943) | Anatomica AB | 2007-05-25 |
| KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES (K070561) | Teleflex Medical | 2007-05-25 |
| PALOMAR ERBIUM HANDPIECE (K071152) | Palomar Medical Products, Inc. | 2007-05-25 |
| AUTO DETECT FOR TELAHEART DR200/E-A (K070014) | North East Monitoring, Inc. | 2007-05-25 |
| MASSTRAK IMMUNOSUPPRESSANTS KIT (K063868) | Waters Corporation | 2007-05-25 |
| DURAMAX REUSABLE OXIMETRY SENSOR (K070408) | Nellcor Puritan Bennett, Inc. | 2007-05-25 |
| ACCU-CHEK PERFORMA SYSTEM (K070585) | Roche Diagnostics Corp. | 2007-05-25 |
| TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A (K071075) | Terumo Corp. | 2007-05-25 |
| MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM (K070239) | Exir Pharmaceutical Co. | 2007-05-25 |
| ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS) (K070887) | Ethicon Endo-Surgery, LLC | 2007-05-25 |
| VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 (K071216) | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 |
| VITREA VERSION 4.0 (K071331) | Vital Images, Inc. | 2007-05-25 |
| VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 (K071215) | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 |
| REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR (K070327) | Sybron Dental Specialties, Inc. | 2007-05-25 |
| ASCENT DENTAL CLEANSER (K070070) | CAO Group, Inc. | 2007-05-25 |
| RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D (K071173) | Ossur Americans (Formerly the Jerome Group) | 2007-05-25 |
| ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 (K070739) | Renal Solutions, Inc. | 2007-05-25 |
| MONARCH NASAL IMPLANT (K071018) | Hanson Medical, Inc. | 2007-05-25 |
| SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) (K070547) | Terumo Europe N.V. | 2007-05-25 |
| DIO PROTEM IMPLANT SYSTEM (K070568) | Dio Department Dsi, Inc. | 2007-05-25 |
| EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES (K062171) | Ortho Development Corp. | 2007-05-25 |
| SYSMEX MODEL UF1000I (K070910) | Sysmex America, Inc. | 2007-05-25 |
| RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 (K063661) | Renu Medical, Inc. | 2007-05-25 |
| SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR (K070595) | Spsmedical Supply Corp. | 2007-05-24 |
| SMARTSPONGE SYSTEM (K071355) | Clearcount Medical Solutions, Inc. | 2007-05-24 |
| IMM HYPODERMIC NEEDLE SET (K070801) | Innovative Medical Manufacturing Co. | 2007-05-24 |
| MODEL PMT850 (K070931) | Promedtek, Inc. | 2007-05-24 |
| RHYTHM TOUCH Q 2-WAY (K063743) | Shockim Enterprises, Ltd. | 2007-05-24 |
| ENDOSSEOUS DENTAL IMPLANT SYSTEM (K070905) | Southern Implants, Inc. | 2007-05-24 |
| ANTLIA I WOUND IRRIGATION SYSTEM (K071301) | Innovative Therapies, Inc. | 2007-05-24 |
| MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR (K071014) | Advanced Sterilization Products | 2007-05-24 |
| TEXIUM SYRINGE (K071108) | Cardinal Health, Alaris Products | 2007-05-24 |
| LIGHT RELIEF, MODEL LR150, LR200 (K070974) | Light Relief, LLC | 2007-05-24 |
| WELMED, INC. SURGICAL GOWNS (K070431) | Welmed, Inc. | 2007-05-24 |
| OSTIAL PRO STENT POSITIONING SYSTEM (K062192) | Ostial Solutions, LLC | 2007-05-24 |
| MICRUS COURIER ENZO MICROCATHETER 0.017 (K070456) | Micrus Endovascular Corporation | 2007-05-24 |
| 5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC (K063269) | Chi Lin Technology Co., Ltd. | 2007-05-23 |
| BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX (K070473) | Zen Strong Medical Technology Co., Ltd. | 2007-05-23 |
| METAL HEMI IMPLANT (K071243) | Orthopro, LLC | 2007-05-23 |
| MP 719 (K070557) | Marine Polymer Technologies, Inc. | 2007-05-23 |
| GASTROSTOMY REPLACEMENT TUBE, MODEL 253 (K070124) | Degania Silicone , Ltd. | 2007-05-23 |
| SALINE/ CONTRAST MEDIA INFUSION CATHETER (K063611) | Utah Medical Products, Inc. | 2007-05-23 |
| VITALITY HIP SYSTEM MODEL#420 (K070050) | Encore Medical L.P. | 2007-05-23 |
| CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES (K070807) | Pepin Mfg., Inc. | 2007-05-23 |
| POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE (K070116) | Smiths Medical MD, Inc. | 2007-05-23 |