| CORELEADER COLLA-PAD MODEL CS 03030 (K102946) | Coreleader Biotech Co., Ltd. | 2011-05-20 |
| K2M COCR WIRE (K103797) | K2m, Inc. | 2011-05-20 |
| JBAIDS Q FEVER DETECTION KIT (K103207) | Idaho Technology, Inc. | 2011-05-20 |
| ZEUS ELISA HSV GG-2 IGG TEST SYSTEM (K103603) | Zeus Scientific, Inc. | 2011-05-20 |
| HYDROFIX VASO SHIELD (K111137) | Mimedx Group, Inc. | 2011-05-20 |
| VITALSENS, AINGEAL, V-POD (K110015) | Intelesens Limited | 2011-05-20 |
| SURESIGNS VS2 VITAL SIGNS MONITOR (K111114) | Philips Medical Systems | 2011-05-20 |
| CLEARCUT S SAFETY KNIFE (K110166) | Alcon Research, Ltd. | 2011-05-20 |
| WITHINGS BLOOD PRESSURE MONITOR (K110872) | Withings | 2011-05-20 |
| EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS (K101090) | Medica Corp. | 2011-05-20 |
| NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 (K102740) | bioMerieux, Inc. | 2011-05-20 |
| CANNABINOIDS URINE TEST (K110182) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-05-20 |
| RMS SUBCUTANEOUS NEEDLE SET (K102512) | Repro-Med Systems, Inc. | 2011-05-20 |
| SURESIGNS VSI VITAL SIGNS MONITOR (K110803) | Philips Medical Systems | 2011-05-20 |
| INTERCONTINENTAL PLATE-SPACER (K103382) | Globus Medical, Inc. | 2011-05-20 |
| EXSALT SD7 WOUND DRESSING (K103067) | Exciton Technologies, Inc. | 2011-05-20 |
| MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM (K110578) | Mar Cor Purification, Inc. | 2011-05-20 |
| LIFTKAR PT (K110495) | Sano Transportgerate GmbH | 2011-05-20 |
| ABS BLOWER, ABS NOZZLE, MODEL 1001 (K092801) | Nimbic Systems, LLC | 2011-05-20 |
| SYNGO NEURO PBV-IR (K111052) | Siemens Medical Solutions USA, Inc. | 2011-05-20 |
| HYPOTHERMX INTRAVENOUS FLUID WARMER (K103801) | Emit Corporation | 2011-05-20 |
| PHOENIX HEMODIALYSIS DELIVERY SYSTEM (K103832) | Gambro Renal Products, Inc. | 2011-05-20 |
| GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT (K102970) | Gyrus Acmi, Inc. | 2011-05-20 |
| ADHESIVE EXL-759 (K110302) | 3M Espe AG | 2011-05-19 |
| SYNTHES HEMOSTATIC BONE PUTTY (HBP) (K103822) | Synthes USA Products, LLC | 2011-05-19 |
| ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL (K100547) | Seppim S.A.S. | 2011-05-19 |
| UNIMAX SUCTION IRRIGATION SET (K103509) | Unimax Medical Systems, Inc. | 2011-05-19 |
| ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM (K111039) | Zimmer, Inc. | 2011-05-19 |
| ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL (K102993) | Seppim S.A.S. | 2011-05-19 |
| ROG KNOTLESS SUTURE ANCHOR (K110230) | Rog Sports Medicine, Inc. | 2011-05-19 |
| CERAMIC BRACKETS (K110335) | Ortho Organizers, Inc. | 2011-05-19 |
| STRYKER PATIENT SPECIFIC CUTTING GUIDE (K110533) | Stryker Corp. | 2011-05-19 |
| ZENIUS SPINAL SYSTEM (K110283) | Medyssey Co, Ltd. | 2011-05-19 |
| ARK CARE DIABETES MANAGMENT SYSTEM (K110709) | Arkray Factory USA, Inc. | 2011-05-19 |
| VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR (K102733) | Vision-Sciences, Inc. | 2011-05-18 |
| ROG SUTURE ANCHOR 5.5MM, 2.9MM (K110229) | Rog Sports Medicine, Inc. | 2011-05-18 |
| TIGERPAW SYSTEM II (K111064) | Laax, Inc. | 2011-05-18 |
| VIDAS TOXO IGG AVIDITY (K101946) | bioMerieux, Inc. | 2011-05-18 |
| BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM (K110574) | Biomet Microfixation, Inc. | 2011-05-18 |
| OIS SYMPHONY IMAGE MANAGMENT SYSTEM (K110006) | Ophthalmic Imaging Systems | 2011-05-18 |
| MITRA-LIFT (K103812) | Sciencity Co., Ltd. | 2011-05-18 |
| CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 (K103377) | Brivant, Ltd. | 2011-05-18 |
| SHASER IPL HAIR REMOVAL SYSTEM (K103560) | Shaser, Inc. | 2011-05-18 |
| DASH KNEE (K102251) | Brainlab AG | 2011-05-17 |
| VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR (K103094) | Edwards Lifesciences, LLC | 2011-05-17 |
| STERILE STORM (R) OPERATING KIT (K111001) | Intelligent Orthopaedics, Ltd. | 2011-05-17 |
| MAC 600 RESTING ECG ANALYSIS SYSTEM (K103765) | Ge Medical Systems Information Technologies, Inc. | 2011-05-17 |
| DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT (K110188) | Diazyme Laboratories | 2011-05-17 |
| SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL (K110484) | Novocol, Inc. | 2011-05-17 |
| CHITOGAUZE FUSION (K111163) | Hem Con Medical Technologies, Inc. | 2011-05-17 |
| IQ VENTILATION NASAL MASK (K102317) | Sleepnet Corporation | 2011-05-17 |
| EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD (K110706) | Exactech, Inc. | 2011-05-17 |
| COLONCAD API 3.1 (K083423) | Medicsight Plc | 2011-05-17 |
| REMOTE VIEW SOFTWARE (K111321) | Cariescan , Ltd. | 2011-05-17 |
| RPS ADENO DETECTOR PLUS (K110722) | Rapid Pathogen Screening, Inc. | 2011-05-17 |
| PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 (K100130) | Mitsubishi Chemical Medience CO | 2011-05-16 |
| OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 (K110986) | Optomed OY | 2011-05-16 |
| CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM (K101779) | Jpi Healthcare Co, Ltd. | 2011-05-16 |
| FUJINON ULTRASONIC PROCESSOR (K111243) | Fujinon, Inc. | 2011-05-16 |
| SIGNATURE PLANNER / SIGNATURE GUIDES (K110415) | Materialise NV | 2011-05-16 |
| ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML (K102535) | Biomerieux S.A. | 2011-05-16 |
| STRATUS CS ACUTE CARE D-DIMER (K110303) | Siemens Healthcare Diagnostics | 2011-05-16 |
| ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 (K102887) | Percutaneous Systems, Inc. | 2011-05-16 |
| S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K110510) | Sonoscape Company Limited | 2011-05-16 |
| BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA (K102328) | Shandong Weigao Group Medical Polymer Co., Ltd. | 2011-05-13 |
| COTRONIC DIGITAL THERMOMETER (K103407) | Cotronic Manufacturing | 2011-05-13 |
| HI-DOW-XP (K102598) | Hi-Dow International, Inc. | 2011-05-13 |
| HEISENBERG DYEING LIQUIDS (K111257) | 3M Espe AG | 2011-05-13 |
| TERUMO SUPPORT CATHETER (K110540) | Terumo Medical Corp. | 2011-05-13 |
| INVADER MTHFR 677 (K100987) | Hologic, Inc. | 2011-05-13 |
| BEAUTIBOND MULTI (K110235) | Shofu Dental Corp. | 2011-05-13 |
| BT-350 (K103545) | Bistos Co., Ltd. | 2011-05-13 |
| COUGAR LS LATERAL CAGE SYSTEM (K110454) | Johnson & Johnson | 2011-05-13 |
| 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T (K102748) | Rapid Biomedical GmbH | 2011-05-13 |
| VR MEDICAL ENTERAL ORAL SYRINGE (K110853) | Vr Medical | 2011-05-13 |
| CLICK-IT (K111234) | Tp Orthodontics, Inc. | 2011-05-13 |
| COMPUTED RADDIOGRAPHY SCANNER (K102619) | 3Disc Americas | 2011-05-13 |
| HEALTH CARE SYSTEM SOFTWARE (K110948) | Taidoc Technology Corporation | 2011-05-13 |
| GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES (K103025) | Given Imaging , Ltd. | 2011-05-13 |
| BD SINGLE USE, HYPODERMIC SYRINGE (K110771) | Becton, Dickinson and Company | 2011-05-13 |
| NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM (K103589) | Natus Medical Incorporated | 2011-05-13 |
| MAHE FIXATION PLATE AND SCREW SYSTEM (K102845) | Mahe Medical GmbH | 2011-05-13 |
| BEAUTIBOND MULTI PR PLUS (K110252) | Shofu Dental Corp. | 2011-05-13 |
| ANGIODYNAMICS, INC. VENACURE 1470 LASER (K110225) | AngioDynamics, Inc. | 2011-05-13 |
| ENDOBON XENOGRAFT GRANULES (K110449) | Biomet 3i | 2011-05-13 |
| NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K110146) | Tangshan Kaiyue Glove Co., Ltd. | 2011-05-13 |
| CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S (K103635) | Aerogen, Ltd. | 2011-05-13 |
| POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG (K110102) | Preventive Care, Inc. | 2011-05-13 |
| ELECTRONIC SPHYGMOMANOMETER (K110774) | Contec Medical System Co., Ltd. | 2011-05-13 |
| VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH (K111121) | Proxy Biomedical , Ltd. | 2011-05-13 |
| ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM (K111227) | Aloka Co., Ltd. | 2011-05-13 |
| ZOLL RESCUENET EPCR MODEL RESCUENET EPCR (K103473) | ZOLL Medical Corporation | 2011-05-13 |
| DIMENSIONS HB1C KIT, MODEL DF105A (K102510) | Siemens Healthcare Diagnostics | 2011-05-13 |
| SYNGO.VIA WEB VIEWER (K111079) | Siemens AG Medical Solutions | 2011-05-13 |
| ELECTRONIC SPHYGMOMANOMETER (K110775) | Contec Medical Systems Co.,Ltd | 2011-05-13 |
| ONESTEP PEDIATRIC MFE'S (K110978) | ZOLL Medical Corporation | 2011-05-13 |
| DROPPER A1C DIABETES CONTROL (K103744) | Quantimetrix Corp. | 2011-05-12 |
| SEASPINE SPACER SYSTEM (K102026) | Seaspine, Inc. | 2011-05-12 |
| MUSTANG BALLOON DILATAION CATHETERS (K110122) | Boston Scientific | 2011-05-12 |
| AURADORM (NEUROMUSCULAR SLEEP) (K101155) | Sleepwright | 2011-05-12 |