| ARS SCREW; SLANT SCREW (K130954) | Advanced Interventional Technology, LLC | 2013-05-31 |
| PELVIS II IMPLANT SYSTEM (K131132) | Stryker Trauma AG | 2013-05-31 |
| INTERLIG (K123823) | Angelus Industria DE Productos Odontologicos | 2013-05-31 |
| TAKE 1 ADVANCE (K130869) | Sybron Dental Specialties | 2013-05-30 |
| ALEUTIAN SPINAL SYSTEM (K130699) | K2m, Inc. | 2013-05-30 |
| ORAMOIST (K122663) | Quantum, Inc. | 2013-05-30 |
| HUMAN IGA CSF KIT FOR USE ON SPAPLUS (K120901) | The Binding Site Group , Ltd. | 2013-05-30 |
| RAMPART O (K131216) | Spineology, Inc. | 2013-05-30 |
| MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE (K130287) | Rhythmlink International, LLC | 2013-05-30 |
| PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS (K123202) | CooperVision, Inc. | 2013-05-30 |
| BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT (K123491) | Biodenta Swiss AG | 2013-05-30 |
| IDRIVE ULTRA STERILIZATION TRAY (K130532) | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-05-30 |
| ULTRAVERSE RX PTA BALLOON DILATATION CATHETER (K131199) | Bard Peripheral Vascular, Inc. | 2013-05-30 |
| FLASH AR PENTA / FLASH AR PENTA QUICK (K131404) | 3M Deutschland GmbH | 2013-05-30 |
| TRANSTEK BODY FAT ANALYZER (K130311) | Guangdong Transtek Medical Electronics Co., Ltd. | 2013-05-30 |
| CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST (K123844) | Chemtron Biotech, Inc. | 2013-05-30 |
| MEMORY PUMP MODEL Y4947 (K131027) | Tomy International | 2013-05-30 |
| FREND PSA PLUS (REAGENT CARTRIDGE) (K124056) | Nanoentek, Inc. | 2013-05-29 |
| MR PERMEABILITY (K130278) | Philips Medical Systems Nederland B.V. | 2013-05-29 |
| ETIAM PACS COMPONENTS (K131392) | Etiam S.A.S.U. | 2013-05-29 |
| 740 SELECT (K130411) | Cas Medical Systems, Inc. | 2013-05-29 |
| ADROIT GUIDING CATHETER (K131225) | Cordis Corp., A Johnson & Johnson Co. | 2013-05-29 |
| ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE (K131045) | Cardiac Designs, LLC | 2013-05-29 |
| STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE (K130288) | Cardiac Insight, Inc. | 2013-05-29 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (K131121) | Health & Life Co., Ltd. | 2013-05-29 |
| MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) (K130354) | Entrigue Surgical, Inc. | 2013-05-29 |
| EXSPIRON 1XI (K130170) | Respiratory Motion, Inc. | 2013-05-29 |
| SCANORA 3DX (K130297) | Palodex Group OY | 2013-05-29 |
| NIO COLOR 3MP LED (K131295) | Barco N.V. | 2013-05-29 |
| VASOSTAT HEMOSTASIS DEVICE (K123041) | Forge Medical, Inc. | 2013-05-29 |
| VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (K123034) | Unilene Sac | 2013-05-28 |
| CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS (K130343) | Corin USA | 2013-05-28 |
| FINGER PULSE OXIMETER (K123801) | Shenzhen Kingyield Technology Co., Ltd. | 2013-05-28 |
| ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM (K131019) | Conformis, Inc. | 2013-05-24 |
| CORIN METAFIX HIP STEM (K130634) | Corin USA | 2013-05-24 |
| CORONIS 3MP (K131246) | Barco N.V. | 2013-05-24 |
| SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK (K130481) | Circadiance, LLC | 2013-05-24 |
| LANX SPINAL FIXATION SYSTEM (K131156) | Lanx, Inc. | 2013-05-24 |
| PIPELINE KNEE SYSTEM (K123692) | Pipeline Orthopedics | 2013-05-24 |
| POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE (K121065) | Polymed Therapeutics, Inc. | 2013-05-24 |
| HEALIX ADVANCE KNOTLESS BR ANCHOR (K130917) | Depuy Mitek, A Johnson & Johnson Company | 2013-05-24 |
| ZENOLUX (K130184) | Wieland Dental + Technik GmbH & Co. KG | 2013-05-24 |
| PROVIDENCE CERVICAL CAGE (K122801) | Providence Medical Technology, Inc. | 2013-05-24 |
| INTRABLOCK BIOBALL HIP SYSTEM (IBS) (K123619) | Merete Medical GmbH | 2013-05-24 |
| ANTEGRADE FEMORAL NAIL (K123569) | Advanced Orthopaedic Solutions, Inc. | 2013-05-24 |
| AMES THERAPY DEVICE (K123746) | Ames Technology, Inc. | 2013-05-24 |
| STAY FRESH SKIN FOLD MANAGEMENT TEXTILE (K121898) | Quick-Med Technologies, Inc. | 2013-05-24 |
| WATER-FILLED TEETHER (K123855) | Solid Toys Ind. , Ltd. | 2013-05-24 |
| SYNTHES SYNCAGE EVOLUTION SPACER (K122639) | Synthes (USA) Products, LLC | 2013-05-24 |
| TERASON USMART3200T ULTRASOUND SYSTEM (K131209) | Teratech Corp. | 2013-05-24 |
| MOBICATH BI-DIRECTIONAL GUIDING SHEATH (K130559) | Great Batch Medical | 2013-05-24 |
| MTM CLEAR ALIGNER IN-OFFICE (K123925) | Dentsply International, Inc. | 2013-05-24 |
| RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER (K130911) | Ev3, Inc. | 2013-05-24 |
| PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K131088) | Sonoscape Company Limited | 2013-05-24 |
| PROFEMUR RENAISSANCE CLASSIC HIP STEM (K130984) | Wrightmedicaltechnologyinc | 2013-05-24 |
| DISCOVERY MR750W 3.0T (K130115) | Ge Medical Systems, LLC | 2013-05-23 |
| ATOM TRANSCAPSULE V-707 (K123937) | Atom Medical Corporation | 2013-05-23 |
| TINA-QUANT HBA1C GEN. 2 TEST SYSTEM (DEN130002) | Roche Diagnostics | 2013-05-23 |
| SANICLAVE 102, MODEL RS-SC-102 (K122978) | Alternative Pioneering Research and Development | 2013-05-23 |
| DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD (K123084) | Elcam Medical Acal | 2013-05-23 |
| IVAS 10MM AND 15MM BALLOON CATHETER (K130430) | Stryker Corporation | 2013-05-23 |
| BREATHID HP SYSTEM (K130524) | Exalenz Bioscience , Ltd. | 2013-05-22 |
| GETINGE 800HC- SERIES STEAM STERILIZER (K122625) | Getinge Sourcing, LLC | 2013-05-22 |
| THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM (K123662) | Justright Surgical, LLC | 2013-05-22 |
| ANYTHINK PACS WORKSTATION (K131299) | Beijing Crealife Technology Co., Ltd. | 2013-05-22 |
| BARLE TISSUE ADHESIVE (K123133) | Advanced Medical Solutions (Plymouth), Ltd. | 2013-05-22 |
| H-30 HOLMIUM LASER SYSTEM (K130444) | Cook, Inc. | 2013-05-22 |
| WINX SLEEP THERAPY SYSTEM (K130538) | Apnicure, Inc. | 2013-05-22 |
| UROMAX ULTRA BALLOON DILATATION CATHETER (K130804) | Boston Scientific Corporation | 2013-05-22 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K130551) | Centers for Disease Control and Prevention | 2013-05-22 |
| SOLANAS POSTERIOR STABILIZATION SYSTEM (K131119) | Alphatec Spine, Inc. | 2013-05-21 |
| DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM (K122519) | Dio Corporation | 2013-05-21 |
| XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) (K130189) | Luminex Molecular Diagnostics, Inc. | 2013-05-21 |
| ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES (K130842) | Philips Medical Systems Nederland B.V. | 2013-05-21 |
| ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM (K131093) | Wrightmedicaltechnologyinc | 2013-05-21 |
| HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) (K130539) | Depuy Mitek, A Johnson & Johnson Company | 2013-05-21 |
| HUMICARE D900 (K122705) | Grundler GmbH | 2013-05-21 |
| COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 (K123726) | Roche Diagnostics | 2013-05-21 |
| TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) (K122214) | Nihon Kohden Corp. | 2013-05-21 |
| REMSTAR SE (K130077) | Respironics, Inc. | 2013-05-21 |
| SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 (K122735) | Sorin Group USA, Inc. | 2013-05-21 |
| ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT (K123322) | Alfa Wassermann Diagnostics Technologies, LLC | 2013-05-21 |
| NORDIC TUMOREX (K123306) | Nordicneurolab | 2013-05-20 |
| ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P (K123115) | Acme Filter Mask, Inc. | 2013-05-20 |
| AIGIS RX R PM/ AIGIS RX R ICD (K130943) | Tyrx, Inc. | 2013-05-20 |
| SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM (K130146) | Synthes (Usa), LLC | 2013-05-20 |
| MIROCAM CAPSULE ENDOSCOPE SYSTEM (K123428) | Intromedic Co., Ltd. | 2013-05-20 |
| 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL (K130457) | Resonance Innovations, LLC | 2013-05-20 |
| ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM (K122804) | Intai Technology Corp. | 2013-05-20 |
| MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT (K130885) | Siemens Medical Solutions USA, Inc. | 2013-05-17 |
| XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML (K130647) | Heraeus Kulzer, LLC | 2013-05-17 |
| DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) (K120671) | Cotronic Technology Limited | 2013-05-17 |
| HUMAN IGG CSF KIT (K120749) | The Binding Site Group , Ltd. | 2013-05-17 |
| NEUROQ 3.6 (K130451) | Syntermed, Inc. | 2013-05-17 |
| THE VAULT SYSTEM (K124051) | Somersault Orthopedics, Inc. | 2013-05-17 |
| KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM (K130377) | Medicatech USA | 2013-05-17 |
| TRYOUT-VPS HOLDING PASTE (K122974) | Crown Delta Corp. | 2013-05-17 |
| MECTALIF ANTERIOR (K124034) | Medacta International | 2013-05-17 |
| RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM (K130105) | Depuy Mitek, A Johnson & Johnson Company | 2013-05-17 |
| AIO HD OTOSCOPE (K123821) | Blue Focus | 2013-05-17 |