| SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 (K100139) | Safelife Corp. | 2010-05-04 |
| KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES (K100306) | Covidien | 2010-05-04 |
| ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA (K100523) | Hygia Health Services, Inc. | 2010-05-04 |
| PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES (K100325) | Smith & Nephew, Inc. | 2010-05-04 |
| HEMOSIL F11 & FV DNA CONTROL (K093737) | Instrumentation Laboratory CO | 2010-05-04 |
| SPERMCHECK FERTILITY (K100341) | Princeton BioMeditech Corp. | 2010-05-04 |
| HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES (K100614) | Blackstone Medical, Inc. | 2010-05-04 |
| ENGSTROM CARESTATION, ENGSTROM PRO (K093886) | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010-05-03 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100733) | Rayen Safety Products Limited | 2010-04-30 |
| DC-7 DIAGNOSTIC ULTRASOUND SYSTEM (K101041) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010-04-30 |
| GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A (K100012) | Depuy Mitek, A Johnson & Johnson Company | 2010-04-30 |
| DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5 (K100723) | Changzhou Kangdi Medical Stapler Co., Ltd. | 2010-04-30 |
| H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F (K092969) | Sterling Medical, Inc. | 2010-04-30 |
| CAAS QVA 3D, CAAS QCA 3D (K100292) | Pie Medical Imaging BV | 2010-04-30 |
| TSRH SPINAL SYSTEM (K091797) | Medtronic Sofamor Danek | 2010-04-30 |
| C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES (K093857) | Lightlab Imaging, Inc. | 2010-04-30 |
| BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM (K091958) | Glenveigh Surgical, LLC | 2010-04-30 |
| RINGLOC + HYBRID ACETABULAR SYSTEM (K093235) | Biomet, Inc. | 2010-04-30 |
| CLICKFINE PEN NEEDLE (K100436) | Ypsomed AG | 2010-04-30 |
| BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES (K092554) | Sunlight Medical, Inc. | 2010-04-30 |
| QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA (K100278) | Maquet Cardiopulmonary, AG | 2010-04-30 |
| ADMIRAL XTREME PTA BALLOON DILATATION CATHETER (K100921) | Invatec S.P.A. | 2010-04-30 |
| OPTIBOND SE (K100347) | Kerr Corporation | 2010-04-30 |
| AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS (K100475) | Howmedica Osteonics Corp. | 2010-04-30 |
| INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 (K100939) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010-04-30 |
| PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J (K100930) | Volcano Corporation | 2010-04-30 |
| PRELOADED TISSUE MARKER DEVICE (K100994) | Carbon Medical Technologies, Inc. | 2010-04-30 |
| STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE (K093263) | Qingdao Lang Hui Import & Export Co., Ltd. | 2010-04-30 |
| INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 (K100915) | Hutchinson Technology, Inc. | 2010-04-30 |
| VSI TORQUE DEVICE (K100093) | Vascular Solutions, Inc. | 2010-04-30 |
| ILUMA VISION MODEL VERSION 2.2 (K094064) | 3M Imtec | 2010-04-30 |
| VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR (K092033) | Elmed USA | 2010-04-30 |
| PRINEO SKIN CLOSURE SYSTEM (DEN090005) | Closure Medical Corp. | 2010-04-30 |
| ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 (K100266) | Camntech, Ltd. | 2010-04-29 |
| BE MICRO, TREA (K093728) | Eb Neuro S.P.A. | 2010-04-29 |
| VITAL SYNC MODEL 5000 SERIES (K093422) | Somanetics Corp. | 2010-04-29 |
| K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (K091486) | Kamiya Biomedical Co. | 2010-04-29 |
| OPAL BOND FLOW (K100301) | Ultradent Products, Inc. | 2010-04-29 |
| MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING (K093899) | Ethicon Endo-Surgery, LLC | 2010-04-29 |
| INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX (K100517) | Instrumed International, Inc. | 2010-04-29 |
| STELLAR 300 (K093017) | Larsen & Toubro Limited | 2010-04-29 |
| DOPPLER FETAL HEARTBEAT RATE DETECTOR (K090510) | Shenzhen Bestman Instrument Co., Ltd. | 2010-04-29 |
| ILLUMINA BEADXPRESS SYSTEM (K093128) | Illumina, Inc. | 2010-04-28 |
| ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II (K093129) | Illumina, Inc. | 2010-04-28 |
| PROFEMUR HIP SYSTEM MODULAR NECKS (K100866) | Wrightmedicaltechnologyinc | 2010-04-28 |
| MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L (K100319) | Merit Medical Systems, Inc. | 2010-04-28 |
| ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM (K093561) | Zimmer, Inc. | 2010-04-28 |
| ROLL-X GUIDEWIRE (K100710) | St Jude Medical | 2010-04-28 |
| ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 (K100258) | Wickimed Supply Limited | 2010-04-28 |
| EXTREMITY MEDICAL SCREW SYSTEM (K093770) | Extremity Medical, LLC | 2010-04-28 |
| SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 (K092611) | Sonarmed, Inc. | 2010-04-28 |
| PIEZOELECTRIC SYSTEM (K100410) | Satelec | 2010-04-28 |
| EPICAGE INTERBODY FUSION DEVICE (K092901) | R Tree Innovations | 2010-04-28 |
| 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 (K100378) | Daavlin Distributing Co. | 2010-04-28 |
| ELECSYS FOLATE III CALCHECK 5 (K094031) | Roche Diagnostics | 2010-04-27 |
| URITEST 50 AND URITEST 500 URINE ANALYZER (K091472) | Arj Medical, Inc. | 2010-04-27 |
| F&P ICON SERIES CPAP (K094040) | Fisher & Paykel Healthcare, Ltd. | 2010-04-27 |
| V7 PORTABLE SUCTION UNITS (K093241) | Hersill, S.L. | 2010-04-27 |
| POLARIS CONTACT LENS CASE (K093377) | Reliance Design & Manufacturing Corp. | 2010-04-27 |
| VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP (K100548) | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2010-04-26 |
| NEXUS PRESSURE RATED EXTENSION SETS (K092382) | Nexus Medical, LLC | 2010-04-26 |
| CRESCENT SPINAL SYSTEM (K094025) | Medtronic Sofamor Danek | 2010-04-26 |
| ENDURAMESH, MODEL 762.XXX (K093207) | Lucero Medical, LLC | 2010-04-26 |
| ELECSYS C-PEPTIDE CALCHECK 5 (K100810) | Roche Diagnostics | 2010-04-26 |
| SURESHOT TAN NAILS AND ACCESSORIES (K092748) | Smith & Nephew, Inc. | 2010-04-26 |
| KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM (K093478) | Trophy | 2010-04-26 |
| VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM (K092171) | Genoray Co., Ltd. | 2010-04-26 |
| SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER (K092911) | Diazyme Laboratories | 2010-04-26 |
| SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (K100268) | Sechrist Industries, Inc. | 2010-04-26 |
| FUORECAM (K093705) | Therapeutic Technologies, Inc. | 2010-04-23 |
| LENSX 550 LASER SYSTEM. MODEL 550 (K094052) | Lensx Lasers, Inc. | 2010-04-23 |
| ERGO IMAGING SYSTEM (K100838) | Digirad Corp. | 2010-04-23 |
| M (K092542) | Mediscitec, Inc. | 2010-04-23 |
| MINXRAY MODEL CMDR-2S (K100449) | Minxray, Inc. | 2010-04-23 |
| ELECSYS TESTOSTERONE II IMMUNOASSAY (K093421) | Roche Diagnostics Corp. | 2010-04-23 |
| DIALYSATE METER, MODEL D-6 (K100237) | Myron L Company | 2010-04-23 |
| PAP-CAP (K100343) | Pur-Sleep, Inc. | 2010-04-23 |
| VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC (K100283) | Cook, Inc. | 2010-04-23 |
| ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276 (K093940) | Taidoc Technology Corporation | 2010-04-23 |
| ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP (K091987) | LeMaitre Vascular, Inc. | 2010-04-23 |
| BILI-MIRROR MODEL BLM-1 (K093618) | Physician Engineered Products, Inc. | 2010-04-23 |
| FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE (K090882) | Hospira, Inc. | 2010-04-23 |
| INFINITY MCABLE - MAINSTREAM CO2 (K100941) | Draeger Medical AG & Co. KG | 2010-04-23 |
| 12 LEAD GLOVE (K100315) | I Needmd, Inc. | 2010-04-23 |
| BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S (K100528) | Breathe Technologies, Inc. | 2010-04-23 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100855) | Suzhou Shengyuda Plastic Products Co., Ltd. | 2010-04-22 |
| ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX (K093977) | Chestnut Medical Technologies, Inc. | 2010-04-22 |
| MODIFICATION TO: HG III ULTRA WIDE SYSTEM (K093889) | Hiossen, Inc. | 2010-04-22 |
| PERIOPHIL B-TCP (K093871) | Cytophil, Inc. | 2010-04-22 |
| HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V (K100454) | MicroVention, Inc. | 2010-04-22 |
| NANOSS BONE VOID FILLER (K100361) | Pioneer Surgical Technology | 2010-04-22 |
| DENTAL HANDPIECE (K093971) | North West Medical Instrument (Group) Co., Ltd. | 2010-04-22 |
| DIAMONDBACK SPINAL SYSTEM (K100377) | Eminent Spine | 2010-04-22 |
| IVUE, MODEL 100 (K091404) | Optovue, Inc. | 2010-04-22 |
| OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 (K100803) | Keymed, Inc. | 2010-04-22 |
| LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART (K100096) | Integra Radionics, Inc. | 2010-04-22 |
| GRAFTY QUICKSET (K093343) | Graftys | 2010-04-22 |
| VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 (K100113) | Sentinelle Medical, Inc. | 2010-04-22 |
| SPECIMEN RETRIEVAL SYSTEM (K100959) | Applied Medical Resources | 2010-04-22 |
| PRESTODR PORTABLE (K100400) | Cmt Medical Technologies, Ltd. | 2010-04-22 |