| COLLAGEN POWDER (K103648) | Innocoll Pharmaceuticals, Ltd. | 2011-09-14 |
| DIGITAL RETINAL CAMERA (K111612) | Canon, Inc. | 2011-09-14 |
| OCTOTMPORT (K112196) | Dalim Surgnet Corporation | 2011-09-14 |
| ELECSYS MYOGLOBIN CALCHECK 5 (K112113) | Roche Diagnostics | 2011-09-14 |
| PADLOCK (K111814) | Reliance Orthodontic Products, Inc. | 2011-09-14 |
| POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K110945) | Zhaoyang Plastic Co., Ltd. | 2011-09-13 |
| XELIS CARDIAC (K111660) | Infinitt Co., Ltd. | 2011-09-13 |
| REUSABLE STIMULATING ELECTRODES (K111270) | Bio Protech, Inc. | 2011-09-13 |
| JBAIDS INFLUENZA A&B DETECTION KIT (K111775) | U.S. Army Medical Material Development Acitvity | 2011-09-13 |
| COLGATE DESENSITIZING DENTAL CREAM (K103461) | Colgate-Palmolive Co. | 2011-09-13 |
| AMCOM COMMTECH MESSENGER (K112047) | Amcom Software,Inc. | 2011-09-13 |
| ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION (K112031) | Alma Lasers, Inc. | 2011-09-13 |
| CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM (K111115) | Captiva Spine, Inc. | 2011-09-13 |
| THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER (K110891) | LeMaitre Vascular, Inc. | 2011-09-13 |
| JBAIDS INFLUENZA A SUBTYPING KIT (K111778) | U.S Army Medical Materiel Development Activity | 2011-09-13 |
| MEDICAL CONCEPTS INTERBODY FUSION SYSTEM (K110659) | Medical Concepts, Inc. | 2011-09-13 |
| SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 (K102483) | Sunset Healthcare Solutions, LLC | 2011-09-13 |
| EPISIL (K101769) | Camurus AB | 2011-09-13 |
| SHEAUMANN PL-1064 (K111359) | Sheaumann Lasers | 2011-09-13 |
| SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. (K111390) | Cendres & Metaux SA | 2011-09-12 |
| STRAUMANN TIBRUSH (K111724) | Straumann USA | 2011-09-12 |
| DISCOVERY (K111484) | Intuitive Spine, LLC | 2011-09-12 |
| WATERPAP VALVE (K110713) | Airways Development, LLC | 2011-09-12 |
| JUELL SOFT CURE (K111178) | Juell Dental | 2011-09-12 |
| SMARTSHEARS (K112400) | Nuscience Consulting and Management Group, LLC | 2011-09-12 |
| JUELL HARD CURE (K111177) | Juell Dental | 2011-09-12 |
| REKA E100 (K111438) | Reka Pte, Ltd. | 2011-09-12 |
| ENDOSKELETON(R) TAS (K111626) | Titan Spine, LLC | 2011-09-09 |
| AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX (K111704) | Avinger, Inc. | 2011-09-09 |
| UNIMAX ANTI-FOG SOLUTION (K111622) | Unimax Medical Systems, Inc. | 2011-09-09 |
| SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES (K112327) | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-09 |
| ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE (K101986) | Asahi Intecc Co., Ltd. | 2011-09-09 |
| CRYOPEN CRYOSURGICAL SYSTEM, K102214 (K110754) | Cryopen, Inc. | 2011-09-09 |
| CLOSUREFAST RADIOFREQUENCY CATHETER (K111887) | Covidien | 2011-09-09 |
| GE VEO RECONSTRUCTION OPTION (K103489) | General Electric Co. | 2011-09-09 |
| .DECIMAL ELECTRON APERTURE (K111759) | .Decimal, Inc. | 2011-09-09 |
| BIOTEQ ANGIOGRAPHIC CATHETER (K102633) | Bioteque Corp. | 2011-09-09 |
| ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 (K111116) | Datex-Ohmeda | 2011-09-09 |
| SMITH & NEPHEW RJ CONSTRAINED LINERS (K111635) | Smith & Nephew, Inc. | 2011-09-09 |
| MRGFUS PELVIC PA COIL MODEL 1.0 (K111060) | Insightech, Ltd. | 2011-09-09 |
| TOSHIBA 3T EXTRA LARGE KNEE COIL (K112313) | Quality Electrodynamics | 2011-09-09 |
| IFS PROFILE PLATES, SCREWS, AND WASHERS (K110086) | Internal Fixation Systems, Inc. | 2011-09-09 |
| WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST (K112395) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-09 |
| AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING (K111285) | Salient Surgical Technologies, Inc. | 2011-09-09 |
| RESOLUTIONMD MOBILE MODEL RMB-MOB-2X (K111346) | Calgary Scientific, Inc. | 2011-09-09 |
| A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) (K111166) | Spineworks, LLC | 2011-09-08 |
| EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM (K112386) | Coloplast Corp. | 2011-09-08 |
| XELIS FUSION (K111613) | Infinitt Co., Ltd. | 2011-09-08 |
| MEDLINE VIAL DECANTER (K111577) | Medline Industries, Inc. | 2011-09-08 |
| RTVUE CAM WITH CORNEAL POWER UPGRADE (K111505) | Optovue, Inc. | 2011-09-08 |
| SV BRAIN ARRAY, SIEMENS 3T (K111802) | Mri Interventions, Inc. | 2011-09-08 |
| FIXATE TISSUE BAND (K111462) | Anulex Technologies, Inc. | 2011-09-08 |
| PREFILLED CATHETER INFLATION SYRINGE (K112209) | Avail Medical Products, Inc. | 2011-09-08 |
| OMNI PATIENT MONITOR (K112329) | Infinium Medical | 2011-09-08 |
| WONDFO METHADONE URINE TEST,OPIATE TEST (K112310) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-08 |
| ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD (K103615) | Alfa Wassermann Diagnostic Technologies, Inc. | 2011-09-08 |
| PROLINK ADHESIVES (PROLINK, PROLINK SE) (K110403) | Silmet , Ltd. | 2011-09-08 |
| POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS (K110818) | Polymedco, Inc. | 2011-09-08 |
| FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI (K103132) | Oculus Private Limited | 2011-09-08 |
| UNITE BIOMATRIX (K112399) | Synovis Orthopedic & Woundcare | 2011-09-07 |
| ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM (K110637) | Cilag GmbH International | 2011-09-07 |
| OPAL BAND CEMENT (K111696) | Ultradent Products, Inc. | 2011-09-07 |
| EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM (K112272) | Eps Bio Technology Corp. | 2011-09-07 |
| EVADYNE TEMPORARY CROWN AND BRIDGE RESIN (K111666) | Neodental Chemical Products Co., Ltd. | 2011-09-07 |
| PILOT SPINAL SYSTEM (K111729) | Life Spine, Inc. | 2011-09-07 |
| CORELEADER HEMO-PAD MODEL CPII 02030 (K102944) | Coreleader Biotech Co., Ltd. | 2011-09-07 |
| IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... (K111650) | Immunodiagnostic Systems , Ltd. | 2011-09-06 |
| XTRA (K112245) | Sorin Group Italia S.R.L. | 2011-09-06 |
| HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON (K111472) | Tgm Medical | 2011-09-06 |
| MYSAFETY SYRINGE (K111734) | Medicalchain Intl. Corp. | 2011-09-06 |
| NM-7000 (K111329) | Nuga Medical Co., Ltd. | 2011-09-06 |
| CERALAS 980NM DIODE LASER FAMILY (K112324) | Biolitec Medical Devices, Inc. | 2011-09-06 |
| FULL CORE BIOPSY SYSTEM (K111765) | Promex Technologies, LLC | 2011-09-06 |
| DIGITAL RADIOGRAPHY (K111682) | Canon Inc. -Medical Equipment Group | 2011-09-02 |
| DIGITAL RADIOGRAPHY (K112309) | Canon Inc. -Medical Equipment Group | 2011-09-02 |
| PROSIM 4, PROSIM 6, PROSIM 8 (K110429) | Fluke Biomedical | 2011-09-02 |
| DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U (K111139) | Ansell Healthcare Products, Inc. | 2011-09-02 |
| FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM (K101631) | Taidoc Technology Corporation | 2011-09-02 |
| COMP A-I-R (K110860) | Omron Healthcare, Inc. | 2011-09-02 |
| IP TEMP CEMENT (K111685) | Shofu Dental Corporation | 2011-09-02 |
| MICROSUTURE ANCHORS (K112237) | Arthrex, Inc. | 2011-09-02 |
| BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION (K110791) | Zimmer, Inc. | 2011-09-02 |
| AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS (K111810) | STERIS Corporation | 2011-09-02 |
| GEM-TONE BODY TRAINING SYSTEM (K102933) | Gemore Technology Co, Ltd. | 2011-09-02 |
| VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM (K112213) | GE Healthcare | 2011-09-01 |
| VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR (K112349) | Covidien, Formerly US Surgical A Divison of Tyco H | 2011-09-01 |
| ROMA (HE4 EIA + ARCHITECT CA 125 II) (K103358) | Fujirebio Diagnostics,Inc. | 2011-09-01 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K110944) | Wangda Plastic Co., Ltd. | 2011-09-01 |
| ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM (K110729) | Fujifilm Medical Systems U.S.A, Inc. | 2011-09-01 |
| VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES (K103331) | STERIS Corporation | 2011-09-01 |
| GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) (K111059) | Gyrus Acmi, Inc. | 2011-09-01 |
| ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE (K110565) | Biomet 3i, Inc. | 2011-09-01 |
| MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG (K110062) | Medipurpose Pte. , Ltd. | 2011-09-01 |
| ALP 501 RB PUMP SYSTEM (K112311) | Currie Medical Specialties, Inc. | 2011-09-01 |
| XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) (K112199) | Luminex Molecular Diagnostics, Inc. | 2011-09-01 |
| POLY-CHEM 90 TOTAL BILIRUBIN (K111143) | Polymedco, Inc. | 2011-09-01 |
| SAPPHIRE NC (K103808) | Orbusneich Medical, Inc. | 2011-09-01 |
| EMG SUCTION UNIT (K112421) | Emg Technology Co., Ltd. | 2011-09-01 |
| MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION (K101204) | Apex BioTechnology Corp. | 2011-08-31 |
| S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM (K112376) | Circa Scientific, LLC | 2011-08-31 |