| DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET (K131556) | Diazyme Laboratories | 2013-06-26 |
| INFINI RADIOFREQUENCY SYSTEM (K121481) | Lutronic Corporation | 2013-06-25 |
| FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE (K130487) | Pyng Medical Corp. | 2013-06-25 |
| DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) (K131314) | Swissray Medical AG | 2013-06-25 |
| PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON (K122503) | Neuro Therm, Inc. | 2013-06-25 |
| TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION (K131489) | Tractus Corporation | 2013-06-25 |
| EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) (K121628) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013-06-25 |
| PRIMI AND SECONDI SUPPORT CATHETERS (K130850) | Thermopeutix, Inc. | 2013-06-25 |
| OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE (K131181) | Omega Laboratories, Inc. | 2013-06-25 |
| DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING (K130008) | I.T.S. GmbH | 2013-06-25 |
| EBA2 FEMORAL NAILING SYSTEM (K131005) | Citieffe S.R.L. | 2013-06-25 |
| SHANGRING (K131373) | Wuhu Snnda Medical Treatment Appliance Technology | 2013-06-25 |
| STEALTH 360 ORBITAL PAD SYSTEM (K131092) | Cardio Systems, Inc. | 2013-06-24 |
| CARDIOSLEEVE (K131287) | Rijuven Corp | 2013-06-24 |
| LAWMAX DILATOR (K123842) | Lifetech Scientific (Shenzhen) Co., Ltd. | 2013-06-24 |
| PROTEUS PATCH INCLUDING INGESTIBLE SENSOR (K131524) | Proteus Digital Health, Inc. | 2013-06-23 |
| HYRDROMAX HMEF (K130664) | A-M Systems | 2013-06-21 |
| LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. (K130295) | Infopia Co, Ltd. | 2013-06-21 |
| TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 (K130099) | Encore Medical L.P. | 2013-06-21 |
| INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) (K130816) | Neuro Resource Group, Inc. | 2013-06-21 |
| BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS) (K124038) | Bedside Clinical Systems, Inc. | 2013-06-21 |
| ION MAGNUM GENIUS (K123158) | Ion Genius, Inc. | 2013-06-21 |
| TEZO TITANIUM CAGE FAMILY (K122957) | Ulrich GmbH & Co. KG | 2013-06-21 |
| DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K130833) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013-06-21 |
| MFM-CMS CENTRAL MONITORING SYSTEM (K120727) | Edan Instruments, Inc. | 2013-06-21 |
| E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM (K131131) | Intromedic Co., Ltd. | 2013-06-21 |
| FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL (K130914) | Biofire Diagnostics, Inc. | 2013-06-21 |
| CERTAIN BELLATEK PROVISIONAL ABUTMENTS (K130310) | Biomet 3i | 2013-06-21 |
| OAK RIDGE PRODUCTS SHARP CONTAINER (K130281) | Oak Ridge Products, LLC | 2013-06-21 |
| VERRATA PRESSURE GUIDE WIRE (K131288) | Volcano Corporation | 2013-06-21 |
| DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K131213) | Sonoscape Company Limited | 2013-06-21 |
| DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A (K123106) | Samsung Electronics Co., Ltd. | 2013-06-20 |
| TITAN (K130795) | Interacoustics A/S | 2013-06-20 |
| ARROW GPSCATH BALLOON DILATATION CATHETER (K130397) | Hotspur Technologies | 2013-06-20 |
| AIRCAST VENAFLOW ELITE SYSTEM (K130722) | Djo, LLC | 2013-06-20 |
| PHYSIOLOGICAL DATA PROCESSOR (K122763) | Zephyr Technology Corporation | 2013-06-20 |
| CELLTRACKS ANALYZER II SYSTEM (K130794) | Veridex, LLC | 2013-06-20 |
| AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) (K112598) | American Surgical Company, LLC | 2013-06-20 |
| SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (K121101) | Astoria-Pacific, Inc. | 2013-06-20 |
| ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM (K130217) | OrthoPediatrics Corp. | 2013-06-20 |
| XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE (K130894) | Cepheid | 2013-06-20 |
| TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED (K131543) | Procter & Gamble Co. | 2013-06-20 |
| FUTURABOND UNIVERSAL (K130486) | Voco GmbH | 2013-06-20 |
| REFORM PEDICLE SCREW SYSTEM (K130279) | Spinal USA | 2013-06-20 |
| EXPEDIUM SPINE SYSTEM (K130877) | Medos International SARL | 2013-06-20 |
| Z5 DIAGNOSTIC ULTRASOUND SYSTEM (K130695) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013-06-19 |
| VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 (K131267) | GE Healthcare | 2013-06-19 |
| HUMAN ALBUMIN CSF KIT (K121045) | The Binding Site Group , Ltd. | 2013-06-19 |
| TRANSTEK BLOOD PRESSURE MONITOR (K131395) | Guangdong Transtek Medical Electronics Co., Ltd. | 2013-06-19 |
| JOULE 810/940/980 MULTI-PLATFORM SYSTEM (K122567) | Sciton, Inc | 2013-06-19 |
| RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 (K130337) | Randox Laboratories Limited | 2013-06-19 |
| BASIXTOUCH (K130566) | Merit Medical Systems, Inc. | 2013-06-19 |
| UNIVERSAL DISTAL RADIUS SYSTEM (K130774) | Newclip Technics | 2013-06-19 |
| CLL- V1 LIGHT SOURCE (K130819) | Olympus Winter & Ibe GmbH | 2013-06-19 |
| VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM (K123007) | Mico Biomed Co., Ltd. | 2013-06-19 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (K130564) | Health & Life Co., Ltd. | 2013-06-19 |
| COALIGN INNOVATIONS ACCULIF XL IBF CAGE (K131443) | Coalign Innovations, Inc. | 2013-06-19 |
| VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS (K123016) | Mico Biomed Co., Ltd. | 2013-06-18 |
| IU22 DIAGNOSTIC ULTRASOUND SYSTEM (K130499) | Philips Ultrasound, Inc. | 2013-06-18 |
| BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM (K130298) | Biopro, Inc. | 2013-06-18 |
| ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM (K131193) | Tactile Systems Technology, Inc. | 2013-06-18 |
| IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D (K123253) | Immunodiagnostic Systems , Ltd. | 2013-06-18 |
| MULTI LEAD TRIAL CABLE (K130545) | St Jude Medical | 2013-06-18 |
| VIKY UP (K122820) | Endocontrol | 2013-06-18 |
| VIVO 50 (K123144) | Ge Healthcare, Breas Medical AB | 2013-06-18 |
| TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM (K123087) | Tyson Bioresearch, Inc. | 2013-06-18 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (K130563) | Health & Life Co., Ltd. | 2013-06-18 |
| DURABLUE STERILIZATION WRAP (K130927) | Cardinal Health200, LLC | 2013-06-18 |
| EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP (K131153) | Evenflo Feeding Incorporated | 2013-06-18 |
| TITAN REVERSE SHOULDER SYSTEM (K130050) | Ascension Orthopedic | 2013-06-18 |
| OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM (K131445) | Osteomed LP | 2013-06-18 |
| RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM (K130309) | Biomet Microfixation | 2013-06-17 |
| Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (K122809) | Advin Biotech | 2013-06-17 |
| SOFIA STREP A FIA (K123793) | Quidel Corporation | 2013-06-17 |
| AZUR PUSHABLE 18 & 35 SYSTEM (K130577) | MicroVention, Inc. | 2013-06-17 |
| DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D (K123431) | Dreamcon Co., Ltd. | 2013-06-17 |
| STELLAR 150 (K122715) | Resmed Germany, Inc. | 2013-06-17 |
| VINYL EXAMINATION POWDER FREE GLOVES, CLEAR (K123590) | Weilin Plastic and Rubber Products Co., Ltd. | 2013-06-17 |
| CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 (K130414) | Trireme Medical, Inc. | 2013-06-15 |
| FRAXEL DUAL 1550/1927 LASER SYSTEM (K130193) | Solta Medical, Inc. | 2013-06-14 |
| OMNICUT RESECTION BLADE (K130912) | Depuy Mitek, A Johnson & Johnson Company | 2013-06-14 |
| ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM (K121214) | Beckman Coulter, Inc. | 2013-06-14 |
| PG-800A SERIES (K131569) | Shenzhen Pango Electronic Co., Ltd. | 2013-06-14 |
| PROVITEMP (K122551) | Itena Clinical | 2013-06-14 |
| CHABNER XRT GARMENTS (K121284) | Chabner Xrt, LLC | 2013-06-14 |
| SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (K130542) | Fujifilm Medical System U.S.A., Inc. | 2013-06-14 |
| AMIA AUTOMATED PD SYSTEM (K124018) | Deka Research & Development Corp. | 2013-06-14 |
| NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY (K130995) | Nuance Medical, LLC | 2013-06-14 |
| ENFLOW IV FLUID WARMER INSULATED STRAP (K130867) | Vital Signs, Inc., A GE Healthcare Company | 2013-06-14 |
| VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 (K123127) | Maine Standards Co. | 2013-06-14 |
| INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 (K130849) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013-06-14 |
| LASER HELMET (K122950) | Theradome, Inc. | 2013-06-14 |
| BEL-GEN COLD STORAGE SOLUTION (K121618) | Waters Medical Systems, LLC | 2013-06-14 |
| PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K130992) | Philips Medical Systems (Cleveland), Inc. | 2013-06-14 |
| TORC BODY (K131291) | Johari Digital Healthcare , Ltd. | 2013-06-14 |
| DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K130801) | Sonoscape Company Limited | 2013-06-14 |
| EMORY CARDIAC TOOLBOX 3.2 (K130902) | Syntermed, Inc. | 2013-06-14 |
| MODULAP LOOP (K121343) | Atc Technologies, Inc. | 2013-06-14 |
| I-MAX TOUCH 3D (K130443) | Owandy | 2013-06-14 |
| PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM (K123810) | CarboFix Orthopedics , Ltd. | 2013-06-14 |