| S8 ASPEN WITH H4I PLUS (K111148) | Resmed Corp | 2011-06-30 |
| SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE (K111107) | Noritake Co., Inc. | 2011-06-30 |
| PROVU (TM) DENTAL X-RAY SYSTEM (K102573) | Advanced Image Science, Inc. | 2011-06-30 |
| GMD UNIVERSAL URINARY INCONTINENCE SLING (K111219) | Generic Medical Device, Inc. | 2011-06-30 |
| SIROCCO THERMAL REGULATING SYSTEM (K102856) | Galmaz Biotech S.L. | 2011-06-30 |
| ZYSTON ARC INTERBODY SPACER (K110650) | Biomet Spine (Aka Ebi, LLC) | 2011-06-30 |
| MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 (K111488) | Bridgepoint Medical | 2011-06-30 |
| SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE (K102177) | Medline Industries, Inc. | 2011-06-30 |
| OCTANE-C INTERBODY FUSION DEVICE SYSTEM (K103655) | Exactech, Inc. | 2011-06-30 |
| GC AADVA BO AC ABUTMENTS (K103234) | GC America, Inc. | 2011-06-30 |
| ACUSON (K111674) | Siemens Medical Solutions USA, Inc. | 2011-06-30 |
| CLIO/CLIOSOFT (K110886) | Sota Precision Optics, Inc. | 2011-06-30 |
| ASICO SOFTIP INJECTOR SYSTEM (K103495) | Asico, LLC | 2011-06-29 |
| CORIN MINIHIP FEMORAL STEM (K111046) | Corin USA | 2011-06-29 |
| MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER (K111672) | Pacific Hospital Supply Co., Ltd. | 2011-06-29 |
| WAVEGUARD (TM) EEG CAP (K110223) | Eemagine Medical Imaging Solutions GmbH | 2011-06-29 |
| THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO (K110616) | Microgenics Corp. | 2011-06-29 |
| PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT (K110099) | CooperVision, Inc. | 2011-06-29 |
| APTUS FOOT 3.5 SYSTEM (K110908) | Medartis AG | 2011-06-28 |
| VITAL SERUM CONTROLS (K111063) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-06-28 |
| VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY (K111180) | Vasomedical, Inc. | 2011-06-28 |
| INDIKO (K110035) | Thermofisher Scientific OY | 2011-06-28 |
| MEDART DIODE LASER SYSTEM & ACCESSORIES (K110243) | Medart A/S | 2011-06-28 |
| IVAS 2-10MM (10 GUAGE) BALLON CATHETER (K103807) | Stryker Corporation | 2011-06-28 |
| LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) (DEN100017) | Tearscience, Inc. | 2011-06-28 |
| HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM (K111340) | Medtec, Inc. | 2011-06-28 |
| PATIENT MONITOR (K101692) | Contec Medical System Co., Ltd. | 2011-06-28 |
| DRYTOUCH SUCTION STIMULATOR PROBE (K110712) | Neurovision Medical Products, Inc. | 2011-06-28 |
| HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER (K110752) | Highland Instruments | 2011-06-28 |
| AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE (K111658) | Medtronic, Inc. | 2011-06-28 |
| BIPOLAR HF DEVICE (K110695) | Aesculap, Inc. | 2011-06-28 |
| HALIFAX BIOMEDICAL TANATLUM BEAD SET (K103417) | Halifax Biomedical, Inc. | 2011-06-28 |
| APEX ARC HIP STEM (K111193) | Omni Life Science, Inc. | 2011-06-27 |
| U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM (K101509) | Taidoc Technology Corporation | 2011-06-27 |
| CONSENSUS KNEE SYSTEM (K110950) | Consensus Orthopedics, Inc. | 2011-06-27 |
| PROFLU+ ASSAY (K110968) | Gen-Probe Prodesse, Inc. | 2011-06-27 |
| CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING (K103520) | Edwards Lifesciences, LLC | 2011-06-24 |
| MONACO RTP SYSTEM (K110730) | Computerized Medical Systems, Inc. | 2011-06-24 |
| IMPAX VOLUME VIEWING (K111638) | Agfa Healthcare N.V. | 2011-06-24 |
| VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY (K111096) | Vasomedical, Inc. | 2011-06-24 |
| CX50 DIAGNOSTIC ULTRASOUND SYSTEM (K111513) | Philips Ultrasound, Inc. | 2011-06-24 |
| VIBERECT PENILE VIBRATORY STIMULATION DEVICE (K110566) | Reflexonic, LLC | 2011-06-24 |
| MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT (K110684) | Vanduzen Dba Medcad | 2011-06-24 |
| F10 (K110630) | Mediana Co., Ltd. | 2011-06-24 |
| IBAG (K110518) | Future Path Medical, LLC | 2011-06-24 |
| NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS) (K111133) | Ssc Surat Thani | 2011-06-24 |
| DISPOSABLE THYROID COLLAR (K110900) | Bloxr Corporation | 2011-06-24 |
| SUREFIRE INFUSION CATHETER SYSTEM (K110459) | Surefire Medical, Inc. | 2011-06-24 |
| BIOPSY HANDY, MRI BIOPSY HANDY (K102771) | Somatex Medical Technologies GmbH | 2011-06-24 |
| MERIT MEDICAL 20 ML SYRINGE (K111091) | Merit Medical Systems, Inc. | 2011-06-24 |
| SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) (K110545) | Smith & Nephew, Inc. | 2011-06-24 |
| INOMAX DSIR (DELIVERY SYSTEM) (K110344) | Ino Therapeutics | 2011-06-24 |
| EPIDUCER LEAD DELIVERY SYSTEM (K110609) | St Jude Medical | 2011-06-24 |
| SUPRIS RETROPUBIC SLING SYSTEM (K111233) | Coloplast A/S | 2011-06-24 |
| SENSI (K110704) | Diacoustic Medical Devices (Pty) , Ltd. | 2011-06-24 |
| 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE (K111581) | Nobel Biocare AB | 2011-06-23 |
| CUROS PORT PROTECTOR (K110826) | Ivera Medical | 2011-06-23 |
| AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE (K111657) | Medtronic, Inc. | 2011-06-23 |
| SURGICAL PROCEDURE PACKS (K110724) | Omnia Spa | 2011-06-23 |
| VISTA DIGITAL OPTHALMOSCOPE (K102412) | Eyequick.Llc | 2011-06-23 |
| AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 (K100716) | Aalto Scientific, Ltd. | 2011-06-23 |
| METAL OPAQUER (K110859) | Apex Dental Materials, Inc. | 2011-06-23 |
| INOMAX DS(IR) (DELIVERY SYSTEM) (K110635) | Ino Therapeutics, LLC/Dba Ikaria | 2011-06-23 |
| WART FREEZE (K101049) | Koninklijke Utermohlen NV | 2011-06-23 |
| CENTURION PRESSURE INJECTABLE EXTENSION SET (K103562) | Centurion Medical Products Corporation | 2011-06-23 |
| LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL (K110239) | Lin-Zhi International, Inc. | 2011-06-23 |
| SOUND SURGICAL VASER 2.1 LIPO SYSTEM (K110306) | Sound Surgical Technologies, LLC | 2011-06-23 |
| ACTIVE WASTE GAS SCAVENGER (K110930) | G. Dundas Co.,Inc. | 2011-06-23 |
| STAT-MAT MINOR (K110500) | Macpherson Medical, Inc. | 2011-06-23 |
| PALOMAR ICON (TM) AESTHETIC SYSTEM (K110907) | Palomar Medical Technologies, Inc. | 2011-06-22 |
| APEX PS KNEE SYSTEM - PS-C INSERT (K111184) | Omni Life Science, Inc. | 2011-06-22 |
| RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS (K110647) | Smith & Nephew, Inc. | 2011-06-22 |
| SURGIVISION INC. CLEARPOINT SYSTEM (K111073) | Surgi-Vision, Inc. | 2011-06-22 |
| ALEUTIAN SPACER SYSTEM (K110843) | K2m, Inc. | 2011-06-22 |
| THE SENSITITRE AIM (K103456) | Trek Diagnostic Systems | 2011-06-22 |
| MICROSCAN MICROSTEP (K111394) | Siemens Healthcare Diagnostics, Inc. | 2011-06-22 |
| UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION (K111444) | DePuy Orthopaedics, Inc. | 2011-06-22 |
| CORELEADER ALGIPLASTER MODEL AP 050501 (K102942) | Coreleader Biotech Co., Ltd. | 2011-06-22 |
| THE PICC WAND (R) PEELABLE SAFETY INTRODUCER (K111138) | Access Scientific, Inc. | 2011-06-22 |
| CUTERA QSWITCH LASER SYSTEM (K102954) | Cutera, Inc. | 2011-06-22 |
| EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 (K102345) | Eps Bio Technology Corp. | 2011-06-21 |
| GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) (K110805) | Orthofix, Inc. | 2011-06-21 |
| ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE (K110946) | Galil Medical , Ltd. | 2011-06-21 |
| ANASCIENT BREATH MONITOR (K110810) | Invoy Technologies, LLC | 2011-06-21 |
| ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH (K110830) | Elitechgroup | 2011-06-21 |
| SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL (K110831) | Sonitus Medical, Inc. | 2011-06-21 |
| ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT (K101005) | Astra Tech AB | 2011-06-21 |
| QLAB 8.1 QUANTIFICATION SOFTWARE (K110414) | Philips Ultrasound, Inc. | 2011-06-21 |
| CT-GUIDE NEEDLE GUIDANCE SYSTEM (K110812) | Activiews, Ltd. | 2011-06-21 |
| TENSCARE ITOUCH SURE MODEL ITS (K103698) | Tenscare, Ltd. | 2011-06-21 |
| CENTRIMAG DRAINAGE CANNULA KIT (K110983) | Levitronix, LLC | 2011-06-20 |
| NUVASIVE LONG LATERAL SPINAL SYSTEM (K111410) | Nuvasive, Inc. | 2011-06-20 |
| IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) (K110889) | Ind Diagnostics, Inc. | 2011-06-20 |
| BIODESIGN NIPPLE RECONSTRUCTION CYLINDER (K110402) | Cook Biotech, Inc. | 2011-06-20 |
| CENTRIMAG RETURN CANNULA KIT (K110980) | Levitronix, LLC | 2011-06-20 |
| EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 (K110509) | Everyway Medical Instruments Co.,Ltd | 2011-06-20 |
| BIOMATE STERILE ACUPUNCTURE NEEDLE (K103061) | Biomate Medical Devices Technology Co., Ltd. | 2011-06-20 |
| ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM (K111086) | OrthoPediatrics Corp. | 2011-06-17 |
| FIT CHECKER ADVANCED (K110871) | GC America, Inc. | 2011-06-17 |
| MEDLINE EPIDURAL AND SPINAL NEEDLES (K110194) | Medline Industries, Inc. | 2011-06-17 |