| MODIFICATION TO: LANX SPINAL FIXATION SYSTEM (K090252) | Lanx, Inc. | 2009-03-04 |
| NANGEL (K083005) | Teknimed, S.A. | 2009-03-04 |
| APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM (K083607) | Cayenne Medical, Inc. | 2009-03-04 |
| CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET (K090348) | Codman & Shurtleff, Inc. | 2009-03-04 |
| OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510 (K083357) | Kci USA, Inc. | 2009-03-04 |
| ENVIRO SHARP SOLUTIONS 3 (K083511) | Industrial Water Solutions, Inc. | 2009-03-03 |
| R3 CONSTRAINED LINER, CONSTRAINED LINER (K083566) | Smith & Nephew, Inc. | 2009-03-03 |
| GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 (K083471) | Generic Medical Device, Inc. | 2009-03-03 |
| ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR (K083788) | Endooptiks, Inc. | 2009-03-03 |
| MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE (K090274) | Micrus Endovascular Corporation | 2009-03-03 |
| REEKROSS FAMILY OR OTW PTA CATHETERS (K083596) | ClearStream Technologies , Ltd. | 2009-03-02 |
| RADIONICS XKNIFE HDRT SYSTEM (K083414) | Integra Radionics, Inc. | 2009-03-02 |
| PHOGLASS CEM (K083766) | S & C Polymer GmbH | 2009-03-02 |
| ATRICURE CRYO1 CRYO-ABLATION PROBE (K082074) | AtriCure, Inc. | 2009-03-02 |
| NEOSS ACCESS ABUTMENTS (K081851) | Neoss, Ltd. | 2009-03-02 |
| NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P (K083456) | Nihon Kohden America, Inc. | 2009-03-02 |
| REPROCESSED EXTERNAL FIXATION DEVICE (K083636) | Sterilmed, Inc. | 2009-03-02 |
| THE PFT FILTER (K083233) | Pulmonary Filtration Technologies, LLC | 2009-03-02 |
| SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 (K083395) | Andon Health Co, Ltd. | 2009-02-27 |
| PRODRIVE LINE OF DENTAL HANDPIECES (K090369) | Prodrive Systems, Inc. | 2009-02-27 |
| BIOCRYL X (K083479) | Great Lakes Orthodontics, Ltd. | 2009-02-27 |
| SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS (K090238) | Sedecal., Sa. | 2009-02-27 |
| AVS TL PEEK SPACERS (K083661) | Stryker Corp. | 2009-02-27 |
| SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG (K082682) | Cook Biotech, Inc. | 2009-02-27 |
| ATMOS C361/C451 SUCTION PUMP (K090445) | Atmos, Inc. | 2009-02-27 |
| VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 (K083680) | Ortho-Clinical Diagnostics, Inc. | 2009-02-27 |
| DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE (K083465) | Siemens Healthcare Diagnostics | 2009-02-27 |
| DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 (K083462) | Siemens Healthcare Diagnostics | 2009-02-27 |
| CONCERTO DETACHABLE COIL SYSTEM (K090046) | Micro Therapeutics, Inc. | 2009-02-27 |
| ERBIUM FRACTIONAL HANDPIECE (K083900) | Palomar Medical Products, Inc. | 2009-02-27 |
| NIM 3.0 (K083124) | Medtronic Xomed, Inc. | 2009-02-27 |
| GLUCODR PLUS SYSTEM, MODEL AGM-3000 (K082328) | All Medicus Co., Ltd. | 2009-02-27 |
| EYE SPHERES (K082850) | Product and Educational Services, LLC | 2009-02-27 |
| PROTRON TECHNOLOGIES, LLC STETHOTRON (K082771) | Protron Technologies, LLC | 2009-02-27 |
| TIGER DISCECTOMY DEVICE (K081240) | Spinal Devices, LLC | 2009-02-27 |
| IMAG, IPOD, EZ-FIND AND ISLIDE (K090362) | Voguestrap | 2009-02-27 |
| MEDILED PHOTOTHERAPY LAMP (K083179) | Medix I.C.S.A. | 2009-02-27 |
| MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS (K090260) | Straumann Manufacturing, Inc. | 2009-02-26 |
| BUSSE SURGICAL DRAPE (K083424) | Busse Hosipital Disposables | 2009-02-26 |
| SILVER ALGINATE 11 WOUND DRESSING (K090453) | Advanced Medical Solutions Limited | 2009-02-26 |
| DX6605E-TENS, DX6605E-G, DX6609-G (K082057) | Shenzhen Dongdixin Technology Co., Ltd. | 2009-02-26 |
| STRAUMANN DENTAL IMPLANT SYSTEM (K083550) | Straumann USA | 2009-02-26 |
| FORA IR22 EAR THERMOMETER, MODEL TD-1262 (K090294) | Taidoc Technology Corporation | 2009-02-26 |
| ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL (K082638) | Siemens Healthcare Diagnostics, Inc. | 2009-02-26 |
| ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) (K083654) | Zimmer, Inc. | 2009-02-26 |
| ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B (K083103) | Acrymed, Inc. | 2009-02-26 |
| LH-75T PHOTOTHERAPY SYSTEM (K090097) | Lerner Medical Devices, Inc. | 2009-02-26 |
| PHARMAJET NEEDLE-FREE INJECTION SYSTEM (K081532) | Pharmajet, Inc. | 2009-02-26 |
| COPA AMD (K082296) | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009-02-26 |
| ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC (K083683) | Genesee Biomedical, Inc. | 2009-02-25 |
| BONEVUE (K083691) | Micromri, Inc. | 2009-02-25 |
| INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5 (K082583) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-02-25 |
| GRAFTYS HBS (K082498) | Graftys | 2009-02-25 |
| CONTEC POCKET FETAL DOPPLER (K082480) | Contec Medical System Co., Ltd. | 2009-02-25 |
| RENASYS GO NEGATIVE PRESSURE WOUND THERAPY (K083375) | Smith & Nephew, Inc. | 2009-02-25 |
| ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES (K082836) | Icu Medical, Inc. | 2009-02-25 |
| QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING (DEN070002) | Quick-Med Technologies, Inc. | 2009-02-25 |
| VISIX IMAGING (K082623) | Televere Systems | 2009-02-25 |
| EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- (K083281) | Linvatec Corp. | 2009-02-25 |
| TAD AND TAD II TAPERED GUIDE WIRES (K083732) | Abbott Vascular | 2009-02-25 |
| PACP (K083663) | Pioneer Surgical Technology | 2009-02-25 |
| NAVIGATION PROBES (K082404) | We Sense, Ltd. | 2009-02-25 |
| LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM (K083324) | Zest Anchors, Inc. | 2009-02-25 |
| NEONATE HEAD AND BODY COILS (K083541) | Advanced Imaging Research, Inc. | 2009-02-24 |
| RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS (K083645) | 5 Star Medical, Inc. | 2009-02-24 |
| BIOACTYS (K082286) | Graftys | 2009-02-24 |
| CHROMOPHARE E 668 (K090378) | Berchtold GmbH & Co. KG | 2009-02-23 |
| RESOLUTIONMD, RELEASE 2.1 (K082693) | Calgary Scientific, Inc. | 2009-02-23 |
| .035 LOC GUIDE WIRE EXTENSION (K083713) | Abbott Vascular | 2009-02-23 |
| DERMABLATE EFFECT (K081541) | Asclepion Laser Technologies GmbH | 2009-02-23 |
| BIVONA TRACHEOSTOMY TUBES (K083641) | Smiths Medical Asd, Inc. | 2009-02-23 |
| E.S TECK ( ELECTRO SENSOR TECK) (K083229) | Ld Technology, LLC | 2009-02-23 |
| RETRACTOR LITE (K083710) | Thomas Surgical Instruments, Inc. | 2009-02-23 |
| SOLAS ANATOMIX SPINAL SYSTEM (K083178) | Biotechni America Spine Group, Inc. | 2009-02-23 |
| NEO-STAT CO2 <KG (K083056) | Mercury Medical | 2009-02-23 |
| GLUSEAL 90, MODEL GLU9010 (K083752) | Glustitch, Inc. | 2009-02-23 |
| INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) (K083879) | Innovision A/S | 2009-02-23 |
| PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES (K083101) | Sable Industries, Inc. | 2009-02-23 |
| BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET (K080008) | Bio-Rad Laboratories, Inc. | 2009-02-23 |
| STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 (K083727) | Bridgepoint Medical | 2009-02-20 |
| GAMMA-BSM, BETA-BSM (K090242) | Etex Corp. | 2009-02-20 |
| ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS (K080481) | Beckman Coulter, Inc. | 2009-02-20 |
| ZEGRA POSTURE TRAINER (K081540) | Peter Fischer | 2009-02-20 |
| TRANSITION STABILIZATION SYSTEM (K073439) | Globus Medical, Inc. | 2009-02-20 |
| EVICEL APPLICATION DEVICE (K090162) | Omrix Biopharmaceuticals , Ltd. | 2009-02-20 |
| G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A (K082201) | U. S. Diagnostics, Inc. | 2009-02-20 |
| DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM (K080853) | Genexel-Sein, Inc. | 2009-02-20 |
| DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 (K083579) | Siemens Healthcare Diagnostics | 2009-02-20 |
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K090334) | Siemens Medi Cal Solutions, Inc. | 2009-02-20 |
| FLOWTAIN & FLOWTAIN LV (K083051) | Reliance Orthodontic Products, Inc. | 2009-02-20 |
| EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT (K080874) | Medica Corp. | 2009-02-20 |
| SCRAMBLER ST 5 TENS DEVICE (K081255) | Competitive Technologies,Inc. | 2009-02-20 |
| XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 (K083778) | Baxter Healthcare Corporation | 2009-02-20 |
| PERIOGENIX (K083516) | Oroscience, Inc. | 2009-02-20 |
| FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM (K083225) | Abbott Diabetes Care, Inc. | 2009-02-20 |
| PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 (K083565) | Smith & Nephew, Inc. | 2009-02-20 |
| ICS CHARTR EP 200 (K083399) | Gn Otometrics A/S | 2009-02-20 |
| ADVANCE A-CLASS TIBIAL INSERT (K081479) | Wrightmedicaltechnologyinc | 2009-02-20 |
| INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE (K090177) | Inion OY | 2009-02-20 |
| FANNING-PAPPAS MODULAR KNEE BEARING (K081400) | Endotec, Inc. | 2009-02-20 |