| IMMULISA DSDNA ANTIBODY ELISA (K101319) | Immco Diagnostics, Inc. | 2010-12-09 |
| NOBEL ACTIVE 3.0 (K102436) | Nobel Biocare AB | 2010-12-09 |
| MULLINS-X PTV CATHETER (K102473) | NuMED, Inc. | 2010-12-09 |
| KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K102609) | Andon Medical Co., Ltd. | 2010-12-09 |
| MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS (K102723) | Memtec Corp. | 2010-12-09 |
| OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS (K102989) | Chang Gung Medical Technology Co., Ltd. Linkou Fac | 2010-12-09 |
| PREVISION HIP SYSTEM WITH RECON RING (K102424) | Aesculap Implant Systems, LLC | 2010-12-09 |
| TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM (K093641) | Tango3, LLC | 2010-12-08 |
| SEEKER CROSSING SUPPORT CATHETER (K103367) | Bard Peripheral Vascular, Inc. | 2010-12-08 |
| OPTIGEN TOTAL KNEE SYSTEM (K102367) | U&I Corp. | 2010-12-08 |
| 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS (K101910) | 3M Company | 2010-12-08 |
| HYDROCOLOR 5 (K102739) | Cascades Device Consulting Associates | 2010-12-08 |
| SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM (K102143) | Suspension Orthopaedic Solutions, LLC | 2010-12-08 |
| CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI (K102965) | Medtrade Products , Ltd. | 2010-12-08 |
| PRUITT CAROTID KIT (K103356) | LeMaitre Vascular, Inc. | 2010-12-08 |
| NEMA-ST, MODEL V1.0.2 (K100668) | Nervomatrix, Ltd. | 2010-12-08 |
| MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER (K102659) | Manuka Medical Limited | 2010-12-08 |
| AURA (K102984) | Sdi Limited | 2010-12-08 |
| QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD (K101153) | Maquet Cardiopulmonary, AG | 2010-12-08 |
| ARMADA 14 PTA CATHETER (K102705) | Abbott Vascular, Inc. | 2010-12-07 |
| SPACELABS MEDICAL PATIENT MONITORS (K102422) | Spacelabs Medical, Inc. | 2010-12-07 |
| VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 (K100739) | Edwards Lifesciences, LLC | 2010-12-07 |
| AIDERA DIASEND SYSTEM (K101806) | Aidera AB | 2010-12-07 |
| NEUMOVENT GRAPHNET MODEL 3179L1V (K101401) | Tecme S.A. | 2010-12-07 |
| S 100 PEDICLE SCREW SYSTEM (K101682) | Renovis Surgical Technologies, LLC | 2010-12-07 |
| ARCOS INTERLOCKING DISTAL STEMS (K100469) | Biomet Manufacturing Corp | 2010-12-07 |
| NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 (K102376) | Nihon Kohden Corp. | 2010-12-07 |
| EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M (K100709) | Edwards Lifesciences, LLC | 2010-12-07 |
| THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES (K102282) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010-12-07 |
| SKELETAL DYNAMICS STERILIZATION TRAYS (K102103) | Skeletal Dynamics, LLC | 2010-12-07 |
| SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM (K102095) | Suspension Orthopaedic Solutions, LLC | 2010-12-07 |
| MEDICAL MAGNETIC TAPE RECORDER (K102111) | Wpr Medical AS | 2010-12-07 |
| PRONEX (K102765) | Direx Systems Corp. | 2010-12-07 |
| VIPER SYSTEM, EXPEDIUM SYSTEM (K101993) | Depuy Spine, Inc. | 2010-12-07 |
| SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (K103340) | Harvest Technologies, Corp. | 2010-12-06 |
| MEDICON MOGEN CLAMP (K100916) | Medicon EG | 2010-12-06 |
| PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH (K103099) | Roche Diagnostics | 2010-12-06 |
| EVERCROSS 0.035 OTW PTA DILATION CATHETER (K103322) | Ev3, Inc. | 2010-12-06 |
| CRYOPETTE (K100596) | Mid-Atlantic Diagnostics, Inc. | 2010-12-06 |
| GC AADVA IMPLANT SYSTEM (K093749) | GC America, Inc. | 2010-12-06 |
| BIOHARNESS (K100040) | Zephyr Technology Corporation | 2010-12-03 |
| RELIANCE ENDOSCOPE PROCESSING SYSTEM (K102244) | STERIS Corporation | 2010-12-03 |
| SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT (K102382) | Cendres & Metaux SA | 2010-12-03 |
| BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES (K100785) | Bonart Co., Ltd. | 2010-12-03 |
| KLASSIC HD HIP SYSTEM (K100445) | Total Joint Orthopedics, Inc. | 2010-12-03 |
| PHYSIOFLOW ENDURO (K103283) | Vasocom, Inc. | 2010-12-03 |
| NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE (K102459) | Hemostasis, LLC | 2010-12-03 |
| PRODESSE PROADENO (K102952) | Gen-Probe Prodesse, Inc. | 2010-12-03 |
| MERETE LOCKING BONE PLATE SYSTEM II (K102688) | Merete Medical GmbH | 2010-12-03 |
| LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS (K101730) | Zimmer, Inc. | 2010-12-03 |
| HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P (K102305) | Hass Corp. | 2010-12-03 |
| ANYPLUS PEEK CAGES (K100516) | GS Medical Co., Ltd. | 2010-12-03 |
| SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE (K101690) | Sentec AG | 2010-12-03 |
| IROOT FS (K102867) | Innovative Bioceramix, Inc. | 2010-12-03 |
| BIOPRO POLAR HEAD (K100761) | Biopro, Inc. | 2010-12-03 |
| SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS (K101224) | Griffiths and Nielsen, Ltd. | 2010-12-03 |
| MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE (K102818) | Micrus Endovascular Corporation | 2010-12-03 |
| MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 (K101835) | Porex Surgical, Inc. | 2010-12-03 |
| PLEURAFLOW CATHETER SYSTEM (K093565) | Clear Catheter Systems | 2010-12-03 |
| GAMMA-BSM; BETA-BSM; EQUIVABONE (K102812) | Etex Corporation | 2010-12-03 |
| ENCODE PATIENT SPECIFIC ABUTMENT (K102209) | Biomet 3i, Inc. | 2010-12-03 |
| PREMIO 10 MOXA (K101267) | Sedatelec | 2010-12-03 |
| VERTEX RAPID SIMPLIFIED (K102654) | Vertex-Dental B.V. | 2010-12-03 |
| LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER (K101229) | Zimmer, Inc. | 2010-12-03 |
| HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM (K101907) | Haemonetics Corp. | 2010-12-03 |
| PATRIOT TRANSCONTINENTAL M SPACERS (K102313) | Globus Medical, Inc. | 2010-12-03 |
| FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS (K102607) | Biomedical Diagnostics (Bmd) SA | 2010-12-03 |
| STELLATE GRIDVIEW (K100126) | Excel-Tech Ltd. (Xltek) | 2010-12-03 |
| PACENTRIC CONNECT, TRAVELER AND WEB (K100837) | Fimreite Software AS | 2010-12-03 |
| BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM (K092587) | Bio-Rad Laboratories | 2010-12-03 |
| PC ECG (K102854) | Edan Instruments, Inc. | 2010-12-03 |
| DMP PIT & FISSURE SEALANT (K102252) | Dmp, Ltd. | 2010-12-03 |
| BOSWORTH AIR POLISHER (K100731) | Harry J. Bosworth Co. | 2010-12-03 |
| CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL (K103314) | Medtronic, Inc. | 2010-12-03 |
| EVOLVE EPS ORTHOLOC (K102352) | Wrightmedicaltechnologyinc | 2010-12-02 |
| ADHESIVE ELECTRODES (K102842) | Reno Medical Limited | 2010-12-02 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) (K102525) | Breathe Technologies, Inc. | 2010-12-02 |
| ELECTROCARDIOGRAPH (K102830) | Edan Instruments, Inc. | 2010-12-02 |
| LAMINOPLASY PLATING SYSTEM (K103284) | Aesculap Implant Systems, Inc. | 2010-12-02 |
| MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES (K101577) | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-12-02 |
| PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) (K102404) | Ventus Medical, Inc. | 2010-12-02 |
| PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS (K101126) | Core Essence Orthopaedics, Inc. | 2010-12-02 |
| CONSENSUS TAPERSET HIP SYSTEM (K102399) | Consensus Orthopedics, Inc. | 2010-12-02 |
| ENVIEW (TM) (K102179) | Carefusion 2200 | 2010-12-02 |
| HYPERQ AD-100 SYSTEM (K102579) | Biological Signal Processing, Ltd. | 2010-12-02 |
| SECRMARK BIOPSY SITE MARKING SYSTEM (K102768) | Hologic, Inc. | 2010-12-02 |
| OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET (K101428) | Ovesco Endoscopy AG | 2010-12-01 |
| NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM (K102514) | Nuvasive, Inc. | 2010-12-01 |
| SL3 (K102639) | Discus Dental, LLC | 2010-12-01 |
| BRAVO PH MONITORING SYSTEM AND ACCESSORIES (K102543) | Given Imaging , Ltd. | 2010-12-01 |
| CONCORDE CURVE SYSTEM (K101923) | Depuy Spine | 2010-12-01 |
| M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 (K103214) | Lifeline Systems, Inc. | 2010-12-01 |
| TOMOPHASE OCTIS (K102599) | Tomophase Corporation | 2010-12-01 |
| CCPOINT (K093908) | Euro-Diagnostica AB | 2010-12-01 |
| HEPARIN ASSAY CONTROLS (K103313) | Medtronic, Inc. | 2010-12-01 |
| SLEEK OTW PTA CATHETERS (K102035) | ClearStream Technologies , Ltd. | 2010-12-01 |
| VITALA CONTINENCE CONTROL DEVICE (K102536) | Convatec, Inc. | 2010-12-01 |
| V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 (K100504) | Valeritas, LLC | 2010-12-01 |
| LLX240AB01 (K102587) | Samsung Mobile Display Co., Ltd. | 2010-12-01 |
| STAXX(R) XD SYSTEM (K102682) | Spine Wave, Inc. | 2010-11-30 |