| EASYSTAND EVOLV (K062402) | Invacare Corp. | 2006-09-21 |
| TYTAN BLOOD PRESSURE CUFF (K062238) | Tytan Medical Corp. | 2006-09-21 |
| SONICWELD RX ENDOBROW FIXATION (K061507) | KLS-Martin L.P. | 2006-09-21 |
| INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES (K062457) | Baxter Healthcare Corporation | 2006-09-21 |
| MAXFORCE TTS SINGLE-USE BALLOON DILATOR (K061787) | Boston Scientific Corp | 2006-09-21 |
| EP NAVIGATOR SOFTWARE (K062650) | Philips Medical Systems | 2006-09-21 |
| OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM (K062423) | Omniguide, Inc. | 2006-09-21 |
| MODIFICATION TO HEXAPOD RT COUCH TOP (K062639) | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2006-09-21 |
| SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS) (K061910) | Synthes (Usa) | 2006-09-21 |
| DERMADAPT WOUND DRESSING (K061494) | Pegasus Biologics, Inc. | 2006-09-21 |
| KIT MENDEC SPINE AND DELIVERY SYSTEM (K062452) | Tecres S.P.A. | 2006-09-21 |
| SURGI-WRAP MAST BIORESORBABLE SHEET (K061473) | Mast Biosurgery USA, Inc. | 2006-09-21 |
| THERMOSUIT SYSTEM (K061023) | Life Recovery Systems Hd, LLC | 2006-09-20 |
| NAVIVISION (K062086) | Brainlab AG | 2006-09-20 |
| MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM (K062594) | Boston Scientific Corporation | 2006-09-20 |
| IGUIDE SYSTEM (K062611) | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2006-09-20 |
| THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS (K062283) | Philips Medical Systems North America, Inc. | 2006-09-20 |
| LYRA ACUPUNCTURE NEEDLES (K062448) | Helio Medical Supplies, Inc. | 2006-09-20 |
| RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 (K062275) | Kerberos Proximal Solutions, Inc. | 2006-09-20 |
| LEICA MODEL FL800 (K061871) | Leica Microsystems, Inc. | 2006-09-20 |
| FETCH ASPIRATION CATHETER (K062172) | Possis Medical, Inc. | 2006-09-20 |
| AVEA VENTILATOR (K062093) | Viasys Respiratory Care, Inc. | 2006-09-20 |
| MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN (K062585) | Dade Behring, Inc. | 2006-09-19 |
| MANTIS SPINAL SYSTEM (K061813) | Stryker Spine | 2006-09-19 |
| MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID (K062596) | Dade Behring, Inc. | 2006-09-19 |
| IQ-SYSTEM PACS SYSTEM (K062488) | Image Information Systems, Ltd. | 2006-09-19 |
| TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT (K061573) | Hospira, Inc. | 2006-09-19 |
| HIERSPEC SPECULUM (K061339) | Medical Products Div. | 2006-09-19 |
| SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 (K062278) | Spacelabs Medical, Inc. | 2006-09-19 |
| EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST (K062235) | Taidoc Technology Corporation | 2006-09-19 |
| ARC SURGICAL BIOTRAK SCREW (K061763) | Arc Surgical, LLC | 2006-09-19 |
| DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL (K061990) | Dade Behring, Inc. | 2006-09-19 |
| VITEK 2 AST-YS FLUCONAZOLE (K061945) | bioMerieux, Inc. | 2006-09-19 |
| PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES (K061790) | Protein Polymer Technologies, Inc. | 2006-09-19 |
| INFANT HEEL WARMER BY INTCO (K053254) | Shanghai Intco Medical Supply Co., Ltd. | 2006-09-19 |
| EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 (K061992) | Eps Bio Technology Corp. | 2006-09-19 |
| CLEARFIL MAJESTY ESTHETIC (K061860) | Kuraray Medical, Inc. | 2006-09-18 |
| DIGI-LITE TCD DEVICE (K062578) | Rimed , Ltd. | 2006-09-18 |
| SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L (K061658) | Dentall Corp. | 2006-09-18 |
| AHMED GLAUCOMA VALVE, MODEL M4 (K060644) | New World Medical, Inc. | 2006-09-18 |
| CONNECT IMAGING PACS (K061972) | Connect Imaging, Inc. | 2006-09-18 |
| CRYSTALVIEW R200 (K062390) | Alara, Inc. | 2006-09-18 |
| GENTLE COLON (REVISION 2.0) (K061532) | Rendoscopy, Inc. | 2006-09-18 |
| OCCULTECH FECAL OCCULT BLOOD RAPID TEST (K060953) | Yd Diagnostics Corp. | 2006-09-18 |
| POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES (K062655) | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2006-09-18 |
| MEDIC4ALL TELEMEDICINE SYSTEM VMS-01 (K061502) | Medic4all (Israel) , Ltd. | 2006-09-15 |
| GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT (K061974) | Instrumentation Laboratory CO | 2006-09-15 |
| ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 (K061190) | Beckman Coulter, Inc. | 2006-09-15 |
| AESCULAP NEURO PATTIES (K062406) | Aesculap, Inc. | 2006-09-15 |
| LIFECATH S PICC AND MIDLINE CATHETER (K062425) | Vygon Corp. | 2006-09-15 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K061659) | Tangshan Luxiong Plastic Products Co., Ltd. | 2006-09-15 |
| WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM (K061877) | Boston Scientific Corp | 2006-09-15 |
| PREVU POINT OF CARE SKIN STEROL TEST (K062092) | Premd, Inc. | 2006-09-15 |
| PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM (K062216) | Smith & Nephew, Inc. | 2006-09-15 |
| DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 (K061864) | Dukal Corp. | 2006-09-15 |
| 29G AND 30G K-PACK II NEEDLE (K062608) | Terumo Europe N.V. | 2006-09-15 |
| MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM (K061741) | GE Healthcare | 2006-09-15 |
| COCHLEA-SCAN / COCHLEA-SCAN PLUS (K061744) | Bio-Logic Systems Corp. | 2006-09-15 |
| NUTRISAFE 2 (K060944) | Vygon Corp. | 2006-09-15 |
| MEDTRONIC PS MEDICAL STRATA TYPE VALUE (K060681) | Medtronic Neurosurgery | 2006-09-15 |
| TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + (K061780) | Rozinn Electronics, Inc. | 2006-09-15 |
| SURGICAL HEADLIGHT (K061690) | Gulf Medical Fiberoptics | 2006-09-15 |
| FUSION (K061557) | Medwave, Inc. | 2006-09-15 |
| ETHMOID SINUS SPACER (K062458) | Acclarent, Inc. | 2006-09-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS (K060770) | Ortho-Clinical Diagnostics, Inc. | 2006-09-15 |
| XPLORER 1100 (K062417) | Imaging Dynamics Company , Ltd. | 2006-09-15 |
| PULSERA (K061685) | Philips Medical Systems North America Co. | 2006-09-15 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K061662) | Tangshan Luxiong Plastic Products Co., Ltd. | 2006-09-15 |
| CONFIDENCE EX HIGH VISCOSITY BONE CEMENT (K062424) | Disc-O-Tech Medical Technologies, Ltd. | 2006-09-14 |
| OVALTWIST PEDICLE SCREW SYSTEM (K061577) | Signus Medizintechnik GmbH | 2006-09-14 |
| STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS (K061225) | Stryker Corp. | 2006-09-14 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS (K060678) | Ortho-Clinical Diagnostics, Inc. | 2006-09-14 |
| DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) (K062162) | Dade Behring, Inc. | 2006-09-14 |
| BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 (K062087) | Bd Biosciences | 2006-09-14 |
| DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 (K062182) | Dade Behring, Inc. | 2006-09-14 |
| DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 (K062391) | Triage Medical, Inc. | 2006-09-14 |
| VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS (K052475) | Vygon Us, LLC | 2006-09-14 |
| TORNIER CEMENT RESTRICTOR (K061824) | Tornier | 2006-09-14 |
| BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE (K061932) | Cardiopulmonary Corp. | 2006-09-14 |
| SEDECAL X PLUS LP PLUS (K062335) | Sedecal., Sa. | 2006-09-14 |
| AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM (K060762) | Aesculap, Inc. | 2006-09-14 |
| LED PROLUX 770 (K061695) | Peng Lim Enterprise Co., Ltd. | 2006-09-14 |
| BAXTER DUPLOSPRAY MIS APPLICATOR (K061092) | Micromedics, Inc. | 2006-09-13 |
| MAMMOPAD RADIOLUCENT CUSHION (K062141) | Biolucent, Inc. | 2006-09-13 |
| PROXIS SYSTEM, MODEL EPS101 (K060651) | St Jude Medical | 2006-09-13 |
| CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 (K062319) | Roche Diagnostics Corp. | 2006-09-13 |
| SPECTRUM M2 MONITOR (K062468) | Spectrum Medical, Llp | 2006-09-13 |
| ARTEGRAL IMCROWN (K061809) | Merz Dental GmbH | 2006-09-13 |
| ALGICELL AG (K052536) | Derma Sciences Canada, Inc. | 2006-09-13 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML (K062207) | Becton, Dickinson & CO | 2006-09-13 |
| XPLORER 1590 (K062405) | Imaging Dynamics Company , Ltd. | 2006-09-13 |
| SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD (K062408) | Smith & Nephew, Inc. | 2006-09-12 |
| OPTECURE +CCC (K061668) | Exactech, Inc. | 2006-09-12 |
| ZEUS MALE CONDOM APPLICATOR (K052206) | Condax, LLC | 2006-09-12 |
| VERTE-STACK SPINAL SYSTEM (K062427) | Medtronic Sofamor Danek | 2006-09-12 |
| INCORIS ZI (K062509) | Sirona Dental Systems GmbH | 2006-09-12 |
| GO GO MINI, MODEL SC30 (K062160) | Pride Mobility Products Corp. | 2006-09-12 |
| DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR (K061795) | Dade Behring, Inc. | 2006-09-11 |
| ENDOFAST RELIANT SYSTEM (K060329) | Endogun Medical Systems | 2006-09-11 |
| MODIFICATION TO DIADEXUS PLAC TEST (K062234) | Diadexus, Inc. | 2006-09-11 |