| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102152) | Hebei Tengda Plastic Co., Ltd. | 2011-04-28 |
| GN OTOMETRICS TYPE 1053 FREEFIT (K110286) | Gn Otometrics A/S | 2011-04-28 |
| ONE DAY FLAT PACK (K102895) | Menicon Co, Ltd. | 2011-04-28 |
| IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) (K103683) | Siemens Healthcare Diagnostics | 2011-04-28 |
| AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP (K102481) | Apex BioTechnology Corp. | 2011-04-28 |
| RENAISSANCE SYSTEM (K110911) | Mazor Robotics , Ltd. | 2011-04-28 |
| SPECTRA LASER SYSTEM (K103455) | Lutronic Corporation | 2011-04-28 |
| VALO CORDLESS (K110582) | Ultradent Products, Inc. | 2011-04-28 |
| BIOMARC FIDUCIAL MARKER (K110772) | Carbon Medical Technologies, Inc. | 2011-04-28 |
| CUTTING EDGE SPINE INTERBODY FUSION DEVICE (K102957) | Cutting Edge Spine, LLC | 2011-04-28 |
| PERIOPATCH (K110750) | Mis Implants Technologies , Ltd. | 2011-04-28 |
| SECTRA MICRODOSE MAMMOGRAPHY (K110025) | Sectra Imtec AB | 2011-04-28 |
| R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (K101578) | R&D Systems, Inc. | 2011-04-28 |
| FEMVUE SALINE-AIR DEVICE (K110288) | Femasys, Inc. | 2011-04-28 |
| PCL TIGHTROPE (K110123) | Arthrex, Inc. | 2011-04-28 |
| BD PEN NEEDLE (K110105) | Becton, Dickinson and Company (BD) | 2011-04-28 |
| DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET (K103557) | Diazyme Laboratories | 2011-04-27 |
| UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 (K103842) | Beckman Coulter, Inc. | 2011-04-27 |
| SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY (K103204) | Solarc Systems, Inc. | 2011-04-27 |
| UNIVERSAL DIGITAL INTERFACE (UDI) 1717 (K103599) | Meridian Medical Systems, LLC | 2011-04-27 |
| POWDERED VINYL PATIENT EXAMINATION GLOVES (K102151) | Hebei Tengda Plastic Co., Ltd. | 2011-04-27 |
| FILMARRAY RP PANEL (K110764) | Idaho Technology, Inc. | 2011-04-27 |
| CUBESCAN / BIOCON-700 (K111021) | Mcube Technology Co., Ltd. | 2011-04-27 |
| TRIPLEX ER. YAG / ND: YAG SYSTEM (K110502) | Sandstone Medical Technologies, LLC | 2011-04-27 |
| IMPELLA CONTROLLER WITH FLOW CONTROL (K110845) | Abiomed, Inc. | 2011-04-27 |
| AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM (K110865) | Tornier, Inc. | 2011-04-27 |
| TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS (K102517) | Thunder Tiger Corp. | 2011-04-27 |
| LIGHTY DD INFUSION SET (K110282) | Medx-Set, Ltd. | 2011-04-27 |
| SENSITITRE AIM (TM) (K110331) | Trek Diagnostic Systems, Ltd. | 2011-04-27 |
| ZEUS ELISA HSV GC-I IGG TEST SYSTEM (K103363) | Zeus Scientific, Inc. | 2011-04-26 |
| NOVAKONE SPHERICAL AND TORIC LENSES (K102557) | Alden Optical Labs., Inc. | 2011-04-26 |
| VAPRO PLUS INTERMITTENT CATHETER (K110862) | Hollister Incorporated | 2011-04-26 |
| PRESTODR 4143 (K110849) | Cmt Medical Technologies, Ltd. | 2011-04-26 |
| AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION (K110834) | GE Healthcare | 2011-04-26 |
| DISPOSABLE INSULIN SYRINGE (K110421) | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011-04-26 |
| DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K110999) | Edan Instruments, Inc. | 2011-04-26 |
| INVADER MTHFR 1298 (K100496) | Hologic, Inc. | 2011-04-25 |
| PROTECTIVE RESTRAINT (K110377) | Medi-Tech Intl. Corp. | 2011-04-25 |
| SOLCART B (K102194) | B. Braun Avitum AG | 2011-04-25 |
| C.T.M. MOBILITY SCOOTER HS515(3W) (K110567) | C.T.M. Homecare Product, Inc. | 2011-04-22 |
| VENX REVOLUTION (K110355) | Venx, LLC | 2011-04-22 |
| AVS ANCHOR-C CERVICAL CAGE SYSTEM (K102606) | Stryker Spine | 2011-04-22 |
| RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR (K102902) | Rubbercare Protection Products Sdn Bhd | 2011-04-22 |
| GSP NEONATAL THYROXINE (T4) (K103484) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-04-22 |
| POSEY BED (K103817) | J. T. Posey Co. | 2011-04-22 |
| REVISION PROTHESIS (K110837) | Smith & Nephew, Inc. | 2011-04-22 |
| WINCO STRETCHAIR (K110671) | Winco Mfg., LLC | 2011-04-22 |
| C.T.M. MOBILITY SCOOTER - MODEL HS 118 (K110395) | C.T.M. Homecare Product, Inc. | 2011-04-22 |
| JETPACK 2.0 (K111024) | Philips Medical Systems (Cleveland), Inc. | 2011-04-21 |
| IFUSE IMPLANT SYSTEM (K110838) | SI-BONE, Inc. | 2011-04-21 |
| HELENA SYSTEM (K110177) | Royal Oak Medical Devices | 2011-04-21 |
| INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM (K103194) | Intra-Lock International, Inc. | 2011-04-21 |
| 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM (K110125) | Synthes USA | 2011-04-21 |
| SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL (K103770) | Syntex Healthcare Products Co., Ltd. | 2011-04-21 |
| BODYFLOW P2CH (K100862) | Physiomed Elektromedizin AG | 2011-04-21 |
| TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) (K110787) | Orthogem Limited | 2011-04-21 |
| EASYRA UREA NITROGEN AND CREATININE REAGENTS (K110675) | Medica Corp. | 2011-04-21 |
| CURVE IMAGE (K110139) | Curve Dental, Inc. | 2011-04-21 |
| EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM (K103602) | Medline Industries, Inc. | 2011-04-21 |
| XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 (K103766) | Cepheid | 2011-04-21 |
| PRECISION LIQUID OXYGEN SYSTEM (K103324) | Precision Medical, Inc. | 2011-04-21 |
| JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM (K110626) | Pathway Medical Technologies, Inc. | 2011-04-20 |
| NEOPIP PATIENT CIRCUIT WITH PEEP (K103833) | Neoforce Group, Inc. | 2011-04-20 |
| SELECTRA CS LEAD INTRODUCER SYSTEM (K110461) | Biotronik, Inc. | 2011-04-20 |
| SYMBIA.NET (K110844) | Siemens Medical Solutions USA, Inc. | 2011-04-20 |
| COMPUTED DENTAL RADIOGRAPHY (K110768) | Schick Technologies, Inc. | 2011-04-20 |
| SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, (K110452) | Unilens Corp., USA | 2011-04-20 |
| SATURN 8000-GS (K110210) | New Medical Co., Ltd. | 2011-04-20 |
| RETCAM 3 OPTHALMIC IMAGING SYSTEM (K102859) | Clarity Medical Systems | 2011-04-20 |
| RESUSCITATION UNIT 105 (K103317) | Atom Medical Corporation | 2011-04-20 |
| CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE (K110112) | Rongshan LI | 2011-04-20 |
| OSTEOSCAF (K101827) | Texas Innovative Medical Devices (Dba) Skeletal | 2011-04-20 |
| FDI GLUCOSE CONTROL SOLUTION FOR AVIVA (K110436) | Fujirebio Diagnostics,Inc. | 2011-04-20 |
| SPI TITANIUM BASE FOR CAD/CAM (K102804) | Thommen Medical AG | 2011-04-20 |
| UCP DRUG SCREENING TEST CUPS (K110515) | Ucp Biosciences, Inc. | 2011-04-20 |
| CRE BALLOON DILATATION CATHETER (K110833) | Boston Scientific Corporation | 2011-04-20 |
| CONSERVE BIO FOAM SHELL (K110029) | Wrightmedicaltechnologyinc | 2011-04-19 |
| SPACELABS SMART DISCLOSURE SYSTEM (K110779) | Spacelabs Healthcare | 2011-04-19 |
| WEXLER VASCULAR CLAMP SERIES (K110148) | Microsurgical Laboratories,Inc.Dba Wexler Surgical | 2011-04-19 |
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |
| BLUE SKY BIO DENTAL IMPLANT SYSTEM (K102034) | Blue Sky Bio, LLC | 2011-04-19 |
| NATUS SLEEPWORKS, MODEL 104017 (K090277) | Excel-Tech Ltd. (Xltek) | 2011-04-19 |
| TRIXEL CO2 LASER (K110434) | BEIJING SYNTECH LASER CO., LTD. | 2011-04-19 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K110338) | Zibo Yuechuan Plastic Products Co., Ltd. | 2011-04-19 |
| PARIETEX OPTIMIZED COMPOSTIE MESH (K110815) | Sofradim Production | 2011-04-19 |
| 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER (K103277) | 3M Company-3M Health Care | 2011-04-19 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K110219) | Wealth on (Jiangsu) Co., Ltd. | 2011-04-19 |
| PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES) (K110816) | Sofradim Production | 2011-04-19 |
| DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS (K093581) | Ge Medical Systems, LLC | 2011-04-19 |
| EVERON CENTRAL DISPLAY STATION (CDS) (K110521) | Earlysense, Ltd. | 2011-04-19 |
| INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA (K102480) | Jieying Laboratory, Inc. | 2011-04-19 |
| FLEXIBLE CARDIAC COIL (K110487) | Lbds Holding Company | 2011-04-19 |
| DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 (K100344) | Siemens Healthcare Diagnostics | 2011-04-18 |
| RESPICHAMBER VALVED HOLDING CHAMBER (K110136) | Trudell Medical Intl. | 2011-04-18 |
| INFILL INTERVERTEBRAL BODY FUSION DEVICE (K103729) | Pinnacle Spine Group, LLC | 2011-04-18 |
| AOI CRANIAL HELMET (K103362) | Advanced Orthopro, Inc. | 2011-04-18 |
| MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER (K100183) | Tanita Corp. | 2011-04-15 |
| DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER (K110841) | Shantou Institute of Ultrasonic Instruments (Siui | 2011-04-15 |
| VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX (K103524) | International Biomedical, Ltd. | 2011-04-15 |
| NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K110921) | Cardinal Health, Inc. | 2011-04-15 |