| SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 (K101145) | Medipurpose Pte. , Ltd. | 2010-10-21 |
| EXACTECH GPS (K100742) | Blue Ortho | 2010-10-21 |
| WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS (K100960) | Cefla Dental Group | 2010-10-21 |
| MASIMO LNCS/M-LNCS OXIMETRY SENSORS (K101896) | Masimo Corporation | 2010-10-21 |
| URGENT PC STIMULATOR; URGENT PC LEAD SET (K101847) | Uroplasty, Inc. | 2010-10-21 |
| G-CATH TISSUE ANCHOR DELIVERY CATHETER (K102916) | Usgi Medical | 2010-10-20 |
| VIPER SPINE SYSTEM (K102701) | Depuy Spine, Inc. | 2010-10-20 |
| JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT (K102088) | Thyssenkrupp Ceteco Srl | 2010-10-20 |
| CONTOURS VSP III VOLAR PLATING SYSTEM (K101936) | Orthofix, Inc. | 2010-10-20 |
| GALAXY LITE (K102031) | Future Mobility Healthcare, Inc. | 2010-10-20 |
| CARESCAPE MODEL V100 VITAL SIGNS MONITOR (K102426) | Ge Medical Systems Information Technologies | 2010-10-20 |
| INTRAFIX TIBIAL SHEATH (K102443) | Depuy Mitek, A Johnson & Johnson Company | 2010-10-20 |
| NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN (K102441) | Nano-Ditech Corporation | 2010-10-20 |
| EXELINT ALUMINUM HUB BLUNT NEEDLES (K101309) | Exelint International, Co. | 2010-10-20 |
| GYRUS ACMI BIOCOAG PROBE (K092571) | Gyrus Acmi, Inc. | 2010-10-20 |
| NANO-CHECK AMI CTNI CARDIAC MARKER TEST (K102131) | Nano-Ditech Corporation | 2010-10-20 |
| THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012 (K092256) | Smiths Medical Asd, Inc. | 2010-10-20 |
| DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY (K101497) | Oscor, Inc. | 2010-10-20 |
| DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT (K101843) | AngioDynamics, Inc. | 2010-10-20 |
| PIONEER CANNULATED SCREW SYSTEM (K102903) | Pioneer Surgical Technology, Inc. | 2010-10-20 |
| UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX (K093244) | Geratherm Medical AG | 2010-10-19 |
| VASOGRAD DVT COMPRESSION GARMENT (K102732) | Compression Therapy Concepts | 2010-10-19 |
| BIO-MODULAR REVERSE SHOLDER (K093803) | Biomet Manufacturing Corp | 2010-10-19 |
| BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 (K101417) | Medipurpose Pte. , Ltd. | 2010-10-19 |
| DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C (K102023) | Shantou Institute of Ultrasonic Instruments (Siui | 2010-10-19 |
| KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER (K102737) | Covidien, LLC | 2010-10-19 |
| HRV ACQUIRE (K092809) | Wr Medical Electronics Co. | 2010-10-19 |
| MEDTOX BUPRENORPHINE TEST (K100951) | Medtox Diagnostics, Inc. | 2010-10-18 |
| IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY (K101911) | Cylex, Inc. | 2010-10-18 |
| LIVEWIRE ELECTOPHYSIOLOGY CATHETER (K102721) | St Jude Medical | 2010-10-18 |
| CARESCAPE MONITOR B650 (K102239) | GE Healthcare Finland Oy | 2010-10-18 |
| PMC LAPAROSCOPIC INSTRUMENTS (K101193) | Pmc Medical GmbH | 2010-10-18 |
| VISTEO (K093105) | Owandy | 2010-10-18 |
| LENSX LASER SYSTEM (K101626) | Lensx Lasers, Inc. | 2010-10-18 |
| MODIFICATION TO:EXPEDIUM SPINE SYSTEM (K101933) | Depuy Spine, Inc. | 2010-10-18 |
| RE-TRACE URETERAL ACCESS SHEATH (K102485) | Coloplast A/S | 2010-10-18 |
| KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP (K093471) | KARL STORZ Endoscopy-America, Inc. | 2010-10-18 |
| WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 (K101597) | Agamatrix | 2010-10-18 |
| REALSEAL XT SEALER (K102163) | Kerr Corporation | 2010-10-16 |
| VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 (K100687) | Vitalograph (Ireland) , Ltd. | 2010-10-16 |
| NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT (K101351) | Ascend Eagle, Inc. | 2010-10-15 |
| VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER (K102774) | Greiner Bio-One North America, Inc. | 2010-10-15 |
| PROTEGRITY SMT LATEX SURGICALGLOVES (K101811) | Cardinal Health, Inc. | 2010-10-15 |
| RPM RESPIRATORY GATING SYSTEM (K102024) | Varian Medical Systems | 2010-10-15 |
| ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 (K101955) | St Jude Medical | 2010-10-15 |
| KAPSS SPINAL SYSTEM (K093833) | Robert Reid, Inc. | 2010-10-15 |
| TARGET DETACHABLE COIL (K102672) | Boston Scientific Corp | 2010-10-15 |
| BEYONDIMAGE WORKSTATION (K102435) | Neusoft Medical Systems Co., Ltd. | 2010-10-15 |
| MYOSURE ROD LENS SCOPE SEALS (K102686) | Interlace Medical, Inc. | 2010-10-15 |
| PINPOINTE FOOTLASER MODEL 6W, 30W, 100W (K093545) | Incisive, Inc. (Formerly Named Incisive, LLC) | 2010-10-15 |
| RANDOX BENZODIAZEPINE ASSAY (K092274) | Randox Laboratories, Ltd. | 2010-10-15 |
| PINPOINTE FOOTLASER (K093547) | Pinpointe USA, Inc. | 2010-10-15 |
| LDR SPINE USA SPINETUNE TL SPINAL SYSTEM (K102331) | Ldr Spine USA | 2010-10-15 |
| ELECTRONIC BLOOD PRESSURE MONITOR (K102920) | Shenzhen Pango Electronic Co., Ltd. | 2010-10-15 |
| PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (K092593) | Atos Medical AB | 2010-10-14 |
| KYPHON XPANDER II INFLATABLE BONE TAMP (K101864) | Medtronic | 2010-10-14 |
| SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM (K101848) | Spinal Elements, Inc. | 2010-10-14 |
| ENDOSSEOUS DENTAL IMPLANT (K093562) | Southern Implants, Inc. | 2010-10-14 |
| SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME (K100593) | Lsi Solutions, Inc. | 2010-10-13 |
| BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS (K100310) | BTL Industries, Inc. | 2010-10-13 |
| HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX (K101271) | Medtronic, Inc. | 2010-10-13 |
| AIXPLORER (K102041) | Supersonic Imagine | 2010-10-13 |
| GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM (K101149) | Ge Vingmed Ultrasound AS | 2010-10-13 |
| COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE (K101518) | Mirador Biomedical, Inc. | 2010-10-13 |
| REL-K ARTIFICAL LIMB PROSTHESIS (K101859) | Rizzoli Ortopedica S.P.A. | 2010-10-13 |
| SMALL PLATEAU SPACER SYSTEM (K093093) | Life Spine | 2010-10-13 |
| IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) (K102325) | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010-10-13 |
| QUANTA FLASH H-TTG IGA (K094060) | Inova Diagnostics, Inc. | 2010-10-13 |
| SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2 (K102671) | Siemens Medical Solutions USA, Inc. | 2010-10-12 |
| EXSALT WOUND DRESSING (K100580) | Exciton Technologies, Inc. | 2010-10-12 |
| COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 (K101987) | Zoll Circulation | 2010-10-12 |
| IMAGYS (K102000) | Keosys Sas | 2010-10-12 |
| EMCOOLSPAD (K100071) | Emcools Emergency Medical Cooling Systems AG | 2010-10-12 |
| IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM (K101700) | Extremity Medical, LLC | 2010-10-12 |
| BLUE SAIL INNOVATION (K102161) | Shandong Blue Sail Innovation Co., Ltd. | 2010-10-08 |
| IONOLUX PRO (K102450) | Voco GmbH | 2010-10-08 |
| FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (K100011) | Fisher & Paykel Healthcare, Ltd. | 2010-10-08 |
| DUOLINK II (K101787) | Bisco, Inc. | 2010-10-08 |
| AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 (K102059) | Olympus Medical Systems Corporation | 2010-10-08 |
| APEXNRG RIDER (K101177) | Medicnrg , Ltd. | 2010-10-08 |
| POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE (K101594) | Better Care Plastic Technology Cp., Ltd. | 2010-10-08 |
| JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD (K100653) | Lang Dental Mfg. Co., Inc. | 2010-10-08 |
| LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE (K101331) | C.R. Bard Inc., Bard Electrophysiology Division | 2010-10-08 |
| SECURMARK BIOPSY SITE MARKING SYSTEM (K102608) | Suros Surgical Systems, Inc. A Hologic Company | 2010-10-08 |
| HT III SA FIXTURE SYSTEM (K101096) | Hiossen, Inc. | 2010-10-08 |
| UNITED U2 BIPOLAR IMPLANT (K101670) | United Orthopedic Corp. | 2010-10-08 |
| OSTENE CT, AOC CT, OSTEOTENE, CERETENE (K102071) | Ceremed , Inc. | 2010-10-08 |
| REMEL SPECTRA MRSA (K092407) | Remel, Inc. | 2010-10-08 |
| MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE (K101280) | Midwest Reprocessing Center, LLC | 2010-10-07 |
| NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 (K100077) | Solaris Medical Technology, Inc. | 2010-10-07 |
| I-LOGIC INREACH SYSTEM (K102604) | Superdimension, Ltd. | 2010-10-07 |
| EXCELLA II SPINAL SYSTEM MODEL EC2-00 (K102248) | Innovasis, Inc. | 2010-10-07 |
| OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM (K101939) | Merete Medical GmbH | 2010-10-07 |
| IMMULISA PR3 ANTIBODY ELISA (K092600) | Immco Diagnostics, Inc. | 2010-10-07 |
| ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE (K102582) | Devon Medical, Inc. | 2010-10-07 |
| ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER (K102632) | Ethicon Endo-Surgery, Inc. | 2010-10-07 |
| 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ (K101166) | GE Healthcare | 2010-10-07 |
| GIRAFFE2 (K102133) | Kerr Corporation | 2010-10-07 |
| VOLPARA, VERSION 1.3 (K102556) | Matakina Technology Limited | 2010-10-07 |
| IMMULISA ANCA SCREEN ELISA (K092601) | Immco Diagnostics, Inc. | 2010-10-07 |