| ZIMMER MMC CUP (K091003) | Zimmer GmbH | 2009-11-24 |
| ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM (K092104) | Arkray Factory USA, Inc. | 2009-11-24 |
| LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (K092656) | Lanx, Inc. | 2009-11-24 |
| MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES (K083123) | Medart A/S | 2009-11-24 |
| MULTIPLE (APEX LOCATOR), MODEL RCM-7 (K090925) | J. Morita USA, Inc. | 2009-11-23 |
| COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM (K083770) | Coloplast A/S | 2009-11-23 |
| HAIRMAX LASERCOMB (K093499) | Lexington International, LLC | 2009-11-23 |
| S. AUREUS/CNS PNA FISH, MODEL KT005 (K092166) | Advandx, Inc. | 2009-11-23 |
| MODIFICATION TO IVENT 101 (K092135) | Versamed Medical Systems , Ltd. | 2009-11-23 |
| VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER (K092687) | A Plus Medical | 2009-11-23 |
| OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP (K093451) | Omniguide, Inc. | 2009-11-20 |
| ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM (K093488) | Aloka Co., Ltd. | 2009-11-20 |
| MICRUS MICROCATHETER, MODEL COURIER 270 (K092702) | Micrus Endovascular Corporation | 2009-11-20 |
| MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE (K090780) | Medtrade Products , Ltd. | 2009-11-20 |
| PALOMAR LUX1540 HANDPIECE (K090195) | Palomar Medical Technologies, Inc. | 2009-11-20 |
| SKYLINE 55, MODEL VER 1 (K092153) | Larsen & Toubro Limited | 2009-11-20 |
| MINI LAP ELECTROCAUTERY INSTRUMENTS (K083754) | Mini Lap Technologies, Inc. | 2009-11-20 |
| SCOUTPRO 7F LONG CATHETERS (K093303) | Biotronik, Inc. | 2009-11-20 |
| AJUST ADJUSTABLE SINGLE INCISION SLING (K092607) | C.R. Bard, Inc. | 2009-11-20 |
| LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) (K092499) | La Glove (M) Sdn. Bhd. | 2009-11-20 |
| ENCOR BREAST BIOPSY SYSTEM (K093512) | Senorx, Inc. | 2009-11-20 |
| ORTHOPANTOMOGRAPH OP30 (K092591) | Instrumentarium Dental, Palodex Group OY | 2009-11-20 |
| ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL (K092993) | Siemens Healthcare Diagnostics | 2009-11-20 |
| AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS (K092178) | Howmedica Osteonics Corp. | 2009-11-20 |
| IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 (K092050) | Phadia AB | 2009-11-20 |
| FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE (K091814) | Taidoc Technology Corporation | 2009-11-20 |
| CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 (K092868) | CellaVision AB | 2009-11-20 |
| NESSI SPACER (K091862) | Pharmacaribe | 2009-11-20 |
| SONIX ULTRASOUND SCANNER (K093462) | Ultrasonix Medical Corporation | 2009-11-20 |
| LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) (K092498) | La Glove (M) Sdn. Bhd. | 2009-11-20 |
| COSMEDENT BRUSHABLE COMPOSITE (K092730) | Cosmedent, Inc. | 2009-11-20 |
| MEDTRADE PRODUCTS CELOX TRAUMA GAUZE (K091795) | Medtrade Products , Ltd. | 2009-11-20 |
| PROPARAFLU+ASSAY (K091053) | Prodesse, Inc. | 2009-11-20 |
| IVD TECHNOLOGIES ACHRAB TEST KIT (K091468) | Ivd Technologies | 2009-11-20 |
| ACU007S (K092522) | Oncology Systems, Inc. | 2009-11-20 |
| OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM (K092395) | Integra Lifesciences Corp. | 2009-11-19 |
| ACUTE AND CHRONIC CATHETER REPAIR KIT (K092797) | Kendall | 2009-11-19 |
| ENDOGATOR (K092429) | Byrne Medical, Inc. | 2009-11-19 |
| BIODRIVE MICRO SCREW SYSTEM (K092670) | Ebi,Llc D/B/A Biomet Trauma | 2009-11-19 |
| MICRODOT XTRA (K083273) | Cambridge Sensors Limited | 2009-11-19 |
| IMMUNOSCAN CCPLUS (K091657) | Euro-Diagnostica AB | 2009-11-19 |
| ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) (K091263) | Materialise NV | 2009-11-19 |
| EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 (K090682) | Edwards Lifesciences Services GmbH | 2009-11-19 |
| RADAR VASCULAR COMPRESSION DEVICES (K092503) | Advanced Vascular Dynamics | 2009-11-19 |
| PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 (K093399) | Inrad | 2009-11-19 |
| KRD1 PEDICLE SCREW SYSTEM (K092420) | Spinefrontier, Inc. | 2009-11-19 |
| PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 (K092040) | R4 Vascular, Inc. | 2009-11-18 |
| STERILE WATER FOR INHALATION FLEX BAG, USP (K090915) | Cardinal Health, Inc. | 2009-11-18 |
| NEWPORT HT70 FAMILY OF VENTILATORS (K090888) | Newport Medical Instruments, Inc. | 2009-11-18 |
| BPZ02 MULTIPURPOSE SOLUTION (K083757) | Bausch & Lomb, Inc. | 2009-11-18 |
| INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 (K091874) | Inomed Medizintechnik GmbH | 2009-11-18 |
| VPS CATHETER (K091924) | Vasonova, Inc. | 2009-11-18 |
| ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 (K091714) | Skyfine Inc. Limited | 2009-11-18 |
| PIONEER SURGICAL NANOSS BVF-E (K091031) | Pioneer Surgical Technology | 2009-11-17 |
| ROSA SURGICAL DEVICE, MODEL ROSA 1.1 (K092239) | Medtech S.A | 2009-11-17 |
| VARIAN INTERSTITIAL TITANIUM NEEDLES (K093291) | Varian Medical Systems, Inc. | 2009-11-17 |
| CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS (K080459) | Chromsystems Instruments & Chemicals GmbH | 2009-11-17 |
| METASUL TAPER LINERS, METASUL FEMORAL HEADS (K091973) | Zimmer GmbH | 2009-11-17 |
| GLUCO LAB AUTO CODING, MODEL IGM-0022 (K091157) | Infopia Co, Ltd. | 2009-11-17 |
| EASYRA MG REAGENT, MODEL 10220 (K092737) | Medica Corp. | 2009-11-17 |
| GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 (K092271) | GE Healthcare | 2009-11-17 |
| SPARTAN S3 FACET SYSTEM (K092568) | Amendia, Inc. | 2009-11-17 |
| SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS (K092556) | Synthes (Usa) | 2009-11-17 |
| SINEXUS SINUS STENT GEN 2, MODEL 1999-25 (K092401) | Sinexus, Inc. | 2009-11-17 |
| OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN (K092374) | Ophthalmic Imaging Systems | 2009-11-17 |
| SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) (K092609) | Synthes (Usa) | 2009-11-17 |
| SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 (K092659) | Spinal USA | 2009-11-17 |
| CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK (K093389) | Computerized Screening, Inc. | 2009-11-17 |
| VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (K093337) | Nanosphere, Inc. | 2009-11-17 |
| SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 (K093256) | Inrad | 2009-11-17 |
| INTREPID SPINAL SYSTEM (K091813) | Medtronic Sofamor Danek | 2009-11-17 |
| INDISCAL ASPIRATION DEVICE AND ACCESSORIES (K092877) | Baylis Medical Co., Inc. | 2009-11-17 |
| LUNGPOINT PROCEDURE PLANNING (K093423) | Broncus Technologies, Inc. | 2009-11-17 |
| XTEND ANTERIOR CERVICAL PLATE SYSTEM (K092146) | Globus Medical, Inc. | 2009-11-16 |
| SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 (K091815) | Biotest Medical Corp. | 2009-11-16 |
| KRYPTONITE BONE CEMENT (K091382) | Doctors Research Group, Inc. | 2009-11-16 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB (K092163) | Health & Life Co., Ltd. | 2009-11-16 |
| GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C (K091664) | Shenzhen Gsd Tech Co., Ltd. | 2009-11-16 |
| OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P (K092549) | Bio Medical Technologies Co., Ltd. | 2009-11-16 |
| ELECSYS HCG+B CALCHECK 5 (K092168) | Roche Diagnostics | 2009-11-16 |
| MAGNUM NAIL (K093089) | Robert Reid, Inc. | 2009-11-13 |
| T.E.A.R. TECH3 (K090532) | Vision Quest Industries, Inc. | 2009-11-13 |
| PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 (K091176) | Philips Medical Systems | 2009-11-13 |
| BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY (K091724) | Becton, Dickinson & CO | 2009-11-13 |
| POWERCROSS .018 OTW PTA DILATION CATHETER (K093286) | Ev3, Inc. | 2009-11-13 |
| BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K091730) | Becton, Dickinson & CO | 2009-11-13 |
| AKITA JET (K090730) | Activaero America, Inc. | 2009-11-13 |
| TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET (K093032) | Biosite Incorporated | 2009-11-13 |
| STA - FREE PS CALIBRATOR (K092113) | Diagnostica Stago, Inc. | 2009-11-13 |
| LEFORTE NEUROSYSTEM BONE SCREW (K091686) | Jeil Medical Corporation | 2009-11-13 |
| SPORT-ELEC BODY CONTROL SYSTEM (K091865) | Sport-Elec | 2009-11-13 |
| LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 (K091754) | Lune Group , Ltd. | 2009-11-13 |
| IMPLICITGUIDE SURGICAL SUTURE SYSTEM (K091061) | Implicitcare, LLC | 2009-11-13 |
| ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER (K092619) | Civco | 2009-11-13 |
| AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY (K093410) | Surgical Devices, A Divsion of Tyco Healthcare | 2009-11-12 |
| NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 (K092246) | Nipro Medical Corporation | 2009-11-12 |
| LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL (K092501) | Novocol, Inc. | 2009-11-12 |
| AUTOSUTURE EEA ORVIL (K093402) | Surgical Devices, A Global Business Unit Tyco | 2009-11-12 |
| V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE (K093408) | Surgical Devices, A Division of Tyco Healthcare | 2009-11-12 |
| AMID STAPLER (K093253) | Safestitch, LLC | 2009-11-12 |