| AMPLATZER TORQ VUE LP DELIVERY SYSTEM (K131063) | St Jude Medical | 2013-08-15 |
| 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER (K130687) | Medical Components, Inc. | 2013-08-15 |
| GMK HINGE (K130299) | Medacta International | 2013-08-15 |
| AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR (K123882) | Ageless Health Industrial | 2013-08-14 |
| LASSO NAV DUO LOOP CATHETER (K130602) | Biosense Webster, Inc. | 2013-08-14 |
| AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM (K130693) | Aseptico, Inc. | 2013-08-14 |
| C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM (K130948) | Southern Spine, LLC | 2013-08-14 |
| MERON APPLICATION CAPSULES (K130421) | Voco GmbH | 2013-08-14 |
| NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER (K131425) | Medtronic Navigation, Inc. | 2013-08-14 |
| PRO HMPV+ ASSAY (K132200) | Gen-Probe Prodesse, Inc. | 2013-08-14 |
| IRIX-C CERVICAL INTEGRATED FUSION SYSTEM (K131951) | X-Spine Systems, Inc. | 2013-08-14 |
| PROADENO+ ASSAY (K132159) | Gen-Probe Prodesse, Inc. | 2013-08-14 |
| GLIDE DEVICE (K131870) | Home Skinovations , Ltd. | 2013-08-14 |
| ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (K131515) | Alfa Wassermann | 2013-08-14 |
| MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (K131247) | Mfs - Medical Flow Systems, Ltd. | 2013-08-14 |
| ACE MONOPOLAR ATTACHMENT (K123061) | Bioeconeer, Inc. | 2013-08-13 |
| EASYSTAND BANTAM MEDIUM (K123834) | Altimate Medical, Inc. | 2013-08-13 |
| EXTRICARE NPWT FOOT DRESSING (K131464) | Devon Medical, Inc. | 2013-08-13 |
| S4C NAVIGATION INSTRUMENTS (K130887) | Aesculap Implant System, Inc. | 2013-08-13 |
| MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT (K130682) | Hager& Meisinger GmbH | 2013-08-13 |
| PRECISE SHP DIODE LASER (K123443) | CAO Group, Inc. | 2013-08-13 |
| HOPER PTCA BALLOON CATHETER (K123473) | Lepu Medical Technology (Beijing) Co., Ltd. | 2013-08-13 |
| HUMELOCK II CEMENTED SHOULDER SYSTEM (K123814) | Fx Solutions | 2013-08-13 |
| OPTIFLOW II FLOWABLE COMPOSITE, LC (K130672) | Pac-Dent International, Inc. | 2013-08-13 |
| SOFIA(R) RSV FIA (K130398) | Quidel Corp. | 2013-08-13 |
| EVICEL APPLICATION DEVICE (K130900) | Ethicon Inc (On Behalf of Omrix Biopharaceuticals | 2013-08-13 |
| PHILIPS SURESIGNS CENTRAL (K131032) | Philips Medical Systems | 2013-08-12 |
| IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL (K131536) | Siemens Healthcare Diagnostics, Inc. | 2013-08-12 |
| VIVORTE BVF LITE (K131133) | Vivorte, Inc. | 2013-08-12 |
| ELECTROMAGNETIC TRANSMITTING STYLET (K131532) | Corpak Medsystems | 2013-08-12 |
| FAHL TRACHEOSTOMY TUBES (MULTIPLE) (K123699) | Andreas Fahl Medizintechnik-Vertrieb GmbH | 2013-08-12 |
| GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM (K123864) | Given Imaging , Ltd. | 2013-08-12 |
| SPARTAN RX CYP2C19 TEST SYSTEM (K123891) | Spartan Bioscience, Inc. | 2013-08-12 |
| CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER (K132197) | Pendracare International, B.V. | 2013-08-12 |
| PANA SPRAY PLUS (K131014) | Nsk America Corp. | 2013-08-12 |
| HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY (K130685) | Hitachi Chemical Diagnostics, Inc. | 2013-08-09 |
| QLAB QUANTIFICATION SOFTWARE (K132165) | Philips Ultrasound, Inc. | 2013-08-09 |
| E-TENG MODEL EOR 1 (K122562) | E-Teng Technology, Inc. | 2013-08-09 |
| FACET SCREW SYSTEM (K130863) | Spinal USA | 2013-08-09 |
| CROSSTREES PVA POD (K130089) | Crosstrees Medical, Inc. | 2013-08-09 |
| ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM (K131419) | I-Sens, Inc. | 2013-08-09 |
| PRODESSE PROFLU+ ASSAY (K132129) | Gen-Probe Prodesse, Inc. | 2013-08-09 |
| PROFTHAND MECHANICAL WHEELCHAIR (K123076) | Harmony Hill International | 2013-08-09 |
| ICONACY I-HIP SYSTEM (K131279) | Iconacy Orthopedic Implants, LLC | 2013-08-09 |
| ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM (K123553) | Zimmer, Inc. | 2013-08-09 |
| CORE PEDICLE SCREW SYSTEM (K131522) | Core-Nexus | 2013-08-09 |
| LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (K131441) | DiaSorin, Inc. | 2013-08-09 |
| ARTHROCARE HEAD AND NECK COBLATION WAND (K131205) | ArthroCare Corporation | 2013-08-09 |
| LIVE VIEW PANEL (LVP) (K131415) | Neurotronics, Inc. | 2013-08-09 |
| METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT (K132226) | Merete Medical GmbH | 2013-08-09 |
| SUREFIX INTERSPINOUS FUSION SYSTEM (K124014) | Jg Spine, LLC | 2013-08-09 |
| ACCU-CHEK AVIVA PLUS TEST STRIP (K131029) | Roche Diagnostics Operations, Inc. | 2013-08-09 |
| CAPSURE PS SYSTEM (K132154) | Spine Wave, Inc. | 2013-08-09 |
| INTEL-GE CARE INNOVATIONS CONNECT RCM (K130821) | Intel-Ge Care Innovations, LLC | 2013-08-09 |
| MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER (K130484) | Boston Scientific Corp | 2013-08-09 |
| PANPAC VAGINAL DILATORS (K130273) | Panpac Medical Corporation | 2013-08-08 |
| OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM (K131810) | Osseus Fusion Systems, LLC | 2013-08-08 |
| EXPANDABLE LUMBAR INTERBODY SYSTEM (K130820) | Nu Vasive, Incorporated | 2013-08-08 |
| PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING (K131674) | Biomet Microfixation | 2013-08-08 |
| QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS (DEN130005) | Centers for Disease Control and Prevention | 2013-08-08 |
| MP VIAL ADAPTER 13MM (K130179) | Medimop Medical Projects, Ltd. | 2013-08-08 |
| GE DATEX-OHMEDA AVANCE CS2 (K131945) | Datex-Ohmeda | 2013-08-08 |
| METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM (K131759) | Tianjin Walkman Biomaterial Co., Ltd. | 2013-08-08 |
| BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 (K132090) | Randox Laboratories, Ltd. | 2013-08-08 |
| COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY (K121610) | Roche Diagnostics Operations | 2013-08-08 |
| PEDIGUARD NERVE DETECTOR SYSTEM (K123390) | Spineguard S.A. | 2013-08-08 |
| PTS-X SIZING BALLOON CATHETER (K131869) | NuMED, Inc. | 2013-08-08 |
| MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN (K130846) | Industrial Clothings, Ltd. | 2013-08-08 |
| CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM (K131538) | Captiva Spine | 2013-08-08 |
| SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE (K131744) | Terumobct, Inc. | 2013-08-08 |
| NMI PORT II CATHETER (K131694) | Navilyst Medical, Inc. | 2013-08-08 |
| ACTIVE BREATHING COORDINATOR (K131313) | Aktina Medical Corp. | 2013-08-07 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K132256) | Becton, Dickinson and Company | 2013-08-07 |
| FIREBIRD SPINAL FIXATION SYSTEM (K130932) | Orthofix, Inc. | 2013-08-07 |
| FOREIGN BODY HOOD (K130148) | United States Endoscopy Group, Inc. | 2013-08-07 |
| I.T.S. EXTREMITY FIXATION SYSTEMS (K131722) | I.T.S. GmbH | 2013-08-07 |
| RSH BILIARY STONE REMOVAL DEVICE (K131642) | Rsh, LLC | 2013-08-07 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K132259) | Becton, Dickinson and Company | 2013-08-07 |
| INTEGRA TITANIUM BONE WEDGE (K131360) | Ascension Orthopedic | 2013-08-07 |
| KATIA SYSTEM (K131512) | Shanghai Sanyou Medical Co, Ltd. | 2013-08-07 |
| QUADCUT (K130608) | Medtronic Navigation, Inc. | 2013-08-07 |
| TIARRAY DENTAL IMPLANT SYSTEM (K131345) | Nasseo, Inc. | 2013-08-07 |
| PROTHELIAL (K123904) | Mueller Medical International, LLC | 2013-08-07 |
| CLEARSPEC SINGLE USE VAGINAL SPECULUM (K130046) | Clearspec, LLC | 2013-08-06 |
| BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (K123047) | Bracco Diagnostic, Inc. | 2013-08-06 |
| FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0 (K131450) | Ostial Corporation | 2013-08-06 |
| OVUSENSE (K122337) | Fertility Focus, Ltd. | 2013-08-06 |
| MENICON NECT CONTACT LENS CASE (K131875) | Foresight Regulatory Strategies | 2013-08-06 |
| THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL (K130743) | Ortho Kinematics, Inc. | 2013-08-06 |
| CD HORIZON SPINAL SYSTEM (K132111) | Medtronic Sofamor Danek USA | 2013-08-06 |
| SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM (K130126) | Biomet, Inc. | 2013-08-06 |
| SYMMETRY KERRISON DISPOSABLE TIP RONGEURS (K130541) | Symmetry Surgical | 2013-08-05 |
| SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (K130342) | Sauflon Pharmaceuticals, Ltd. | 2013-08-05 |
| PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES (K122610) | Sen MU Technology Co., Ltd. | 2013-08-05 |
| JBAIDS ANTHRAX DETECTION KIT (K131930) | Biofire Diagnostics, Inc. | 2013-08-05 |
| EPIDOSE (K131704) | Sun Nuclear Corporation | 2013-08-05 |
| EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME (K132190) | LeMaitre Vascular, Inc. | 2013-08-05 |
| EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM (K122883) | Stelkast Company | 2013-08-05 |
| MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM (K122553) | ACON Laboratories, Inc. | 2013-08-05 |
| PRIMATRIX DERMAL REPAIR SCAFFOLD (K131286) | Tei Biosciences, Inc. | 2013-08-05 |