| MAYFIELD INFINITY XR2 SKULL CLAMP (K130389) | Integra LifeSciences Corporation | 2013-04-23 |
| ERCHONIA PL5000 (K130741) | Erchonia Medical, Inc. | 2013-04-23 |
| ENCIRCLE COMPRESSION THERAPY STOCKING (K122485) | Encircle Medical Devices , Ltd. | 2013-04-23 |
| ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE (K123018) | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-04-23 |
| NXSTAGE SYSTEM ONE (K122051) | Nxstage Medical, Inc. | 2013-04-23 |
| PASSEO-35 (K130161) | Biotronik, Inc. | 2013-04-23 |
| NUVASIVE NVM5 SYSTEM (K123307) | Nuvasive, Inc. | 2013-04-23 |
| AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES (K123973) | Pegavision Corporation | 2013-04-23 |
| AAP CANNULATED SCREW 2.0 (K130590) | Aap Implantate AG | 2013-04-22 |
| NEXFIN MODEL 2 (K122381) | Edwards Lifesciences, LLC | 2013-04-22 |
| NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) (K130318) | Varian Medical Systems, X-Ray Products-Infimed | 2013-04-22 |
| XHIBIT CENTRAL STATION, MODEL 96102 (K122146) | Spacelabs Healthcare | 2013-04-22 |
| STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK (K123539) | Stayhealthy, Inc. | 2013-04-22 |
| NEXXIS OR (K122167) | Barco N.V. | 2013-04-22 |
| DIODE LASER (K123483) | BEIJING SYNTECH LASER CO., LTD. | 2013-04-21 |
| FIBRILLAR COLLAGEN WOUND DRESSING (K120250) | Collafirm, LLC | 2013-04-21 |
| AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT (K123716) | Applied Medical Technology, Inc. | 2013-04-19 |
| DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS (K130108) | Xiamen Double Engine Medical Material Co., Ltd. | 2013-04-19 |
| INSTINCT JAVA SYSTEM (K123552) | Zimmer Spine | 2013-04-19 |
| PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM (K121804) | Itena Clinical | 2013-04-19 |
| NEWFIX EXTERNAL FIXATION SYSTEM (K122210) | Tecnologia Y Diseno Industrial, S.A DE C.V | 2013-04-19 |
| FALLER STYLET (K130441) | Medionics International, Inc. | 2013-04-19 |
| ARCOS TROCHANTER BUTTON (K130063) | Biomet, Inc. | 2013-04-19 |
| BIOSPHERE BIOACTIVE BONE GRAFT PUTTY (K122868) | Synergy Biomedical, LLC | 2013-04-19 |
| ELECTRODE, FLEXIBLE SUCTION COAGULATOR (K130489) | Optim, LLC | 2013-04-19 |
| PROFEMUR XM DISTAL CENTRALIZER (K130167) | Wrightmedicaltechnologyinc | 2013-04-19 |
| MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX (K130335) | Medtronic Sofamor Danek USA, Inc. | 2013-04-19 |
| MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM (K122539) | Siemens Healthcare Diagnostics | 2013-04-19 |
| ECAT SCINTRON PET (K130269) | Miegmbh | 2013-04-19 |
| MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR (K130772) | Nec Display Solutions , Ltd. | 2013-04-18 |
| PREXION3D ECLIPSE (K122199) | The Yoshida Dental Mfg. Co., Ltd. | 2013-04-18 |
| EPICAGE INTERBODY FUSION DEVICE (K130548) | Alphatec Spine, Inc. | 2013-04-18 |
| RHYTHMIA MAPPING CATHETER (K122461) | Rhythmia Medical, Inc. | 2013-04-18 |
| HYDRASOLVE LIPOPLASTY SYSTEM (K130152) | Andrew Technologies, LLC | 2013-04-18 |
| ENDO GIA RELOAD (K130717) | Covidien, Formerly US Surgical A Divison of Tyco H | 2013-04-18 |
| COMINED STANDARD SOLUTION (K130100) | Mesa Laboratories, Inc. | 2013-04-18 |
| SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T (K130883) | Sedecal., Sa. | 2013-04-18 |
| CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES (K123676) | Mauna Kea Technologies | 2013-04-18 |
| BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS) (K121659) | Arcos, Inc. | 2013-04-18 |
| DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM (K124049) | Spectralmd, Inc. | 2013-04-18 |
| SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 (K123900) | Philips Medical Systems | 2013-04-18 |
| MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR (K130770) | Nec Display Solutions , Ltd. | 2013-04-18 |
| A3F FRATIONAL (K122200) | Pollogen, Ltd. | 2013-04-18 |
| NEOCLOSE HASSON, NEOCLOSE UNIVERSAL (K123280) | Neosurgical, Ltd. | 2013-04-18 |
| SLEEP PROFILER (K130007) | Advanced Brain Monitoring, Inc. | 2013-04-17 |
| HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER (K121770) | Headstar Medical Products Co., Ltd. | 2013-04-17 |
| INSTAFLO BOWEL CATHETER SYSTEM KIT (K123804) | Hollister, Inc. | 2013-04-17 |
| PLASMATRODE SALINE SAFE TUR ELECTRODE (K122716) | Cook Ireland, Ltd. | 2013-04-17 |
| TRUECPR COACHING DEVICE (K123597) | Physio-Control, Inc. | 2013-04-17 |
| LTN - LAPAROSCOPIC SURGICAL MESH (K130817) | Lifecell Corp. | 2013-04-17 |
| VS3 (K123467) | Visionsense, Ltd. | 2013-04-17 |
| QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, (K123593) | Inova Diagnostics, Inc. | 2013-04-17 |
| MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C (K124009) | Diamond Diagnostics, Inc. | 2013-04-17 |
| M300 & M400 (K123290) | Permobil AB | 2013-04-17 |
| COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT (K123083) | Covidien | 2013-04-17 |
| IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION (K130535) | Agamatrix, Inc. | 2013-04-17 |
| STRIVE DUAL ZONE PEAK FLOW METER (K123945) | Monaghan Medical Corp. | 2013-04-17 |
| MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. (K130725) | Covidien Lp, Formerly Registered AS Kendall | 2013-04-17 |
| BRIGADE STANDALONE SYSTEM (K123045) | Nuvasive, Inc. | 2013-04-16 |
| SIGN PEDIATRIC FIN NAIL (K122823) | Sign Fracture Care International | 2013-04-16 |
| PAINMASTER MCT PATCH (K130114) | Newmark, Inc. | 2013-04-16 |
| PEERSCOPE SYSTEM (K130718) | Peermedical , Ltd. | 2013-04-16 |
| LOSPA TOTAL KNEE REPLACEMENT SYSTEM (K130673) | Corentec Co., Ltd. | 2013-04-15 |
| VIVASIGHT-DL SYSTEM (K123853) | Etview , Ltd. | 2013-04-15 |
| AESCULAP CESPACE XP (K123909) | Aesculap Implant System, Inc. | 2013-04-15 |
| OPTICROSS 40 MHZ CORONARY IMAGING CATHETER (K123621) | Boston Scientific Corp | 2013-04-15 |
| PERSONAL HEALTH CENTER (PHC) (K122076) | Adflow Health Networks, Inc. | 2013-04-15 |
| Z CARTRIDGE IOL DELIVERY SYSTEM (K123888) | Aaren Scientific, Inc. | 2013-04-15 |
| YOULASER CO2 LASER (K123573) | Quanta System Spa | 2013-04-15 |
| HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS (K122304) | The Binding Site Group , Ltd. | 2013-04-15 |
| BIOMARC GOLD FIDUCIAL MARKER (K130678) | Carbon Medical Technologies, Inc. | 2013-04-12 |
| LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK (K130761) | Bio-Rad Laboratories | 2013-04-12 |
| UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM (K130803) | Samsung Medison Co., Ltd. | 2013-04-12 |
| EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) (K113439) | Euroimmun US | 2013-04-12 |
| IOLMASTER 500 (K122418) | Carl Zeiss Meditec, AG | 2013-04-12 |
| MICROSLIDER TEARAWAY INTRODUCER SET (K123430) | Galt Medical Corp. | 2013-04-12 |
| QUIKCLOT HEMOSTATIC DRESSING (K123387) | Z-Medica, LLC | 2013-04-12 |
| PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 (K122537) | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2013-04-12 |
| XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION (K130884) | Ge Medical Systems F.I. Haifa | 2013-04-12 |
| ZMED VP4000 (K130929) | Zmed, Inc. | 2013-04-12 |
| APTUS HELI-FX AORTIC SECUREMENT SYSTEM (K130677) | Aptus Endosystems, Inc. | 2013-04-12 |
| INTRAMEDULLARY NAIL SYSTEM (K122994) | Weigao Orthopaedic Device Co., Ltd. | 2013-04-12 |
| PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K130119) | Sonoscape Company Limited | 2013-04-12 |
| NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO (K122223) | Philips Medizin Systeme Boeblingen GmbH | 2013-04-12 |
| IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM (K123935) | Andon Medical Co., Ltd. | 2013-04-12 |
| MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE (K122464) | Industrial Clothings, Ltd. | 2013-04-12 |
| FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING (K122239) | Encore Medical L.P. | 2013-04-11 |
| SHORT PORT BLUNT TIP TROCAR (K130121) | Boston Scientific Corporation | 2013-04-11 |
| S4 SPINAL SYSTEM (K130291) | Aesculap Implant System, Inc. | 2013-04-11 |
| STORM MINI SCREW (K122069) | Lancer Orthodontics, Inc. | 2013-04-11 |
| SINGLE USE PRELOADED SPHINCTEROTOME V (K122505) | Olympus Medical Systems Corp. | 2013-04-11 |
| STAXX(R) IB SYSTEM (K123461) | Spine Wave, Inc. | 2013-04-11 |
| EPIC 10S (K130465) | Biolase Technology, Inc. | 2013-04-11 |
| PASTELLE Q-SWITCHED ND: YAG LASER (K123293) | Won Technology Co., Ltd. | 2013-04-11 |
| INFINITY CENTRALSTATION WITH INFINITY M300 (K130711) | Draeger Medical Systems, Inc. | 2013-04-11 |
| SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM (K122455) | Synthes | 2013-04-11 |
| HEALICOIL SUTURE ANCHOR WITH REGENESORB (K123393) | Smith & Nephew, Inc. | 2013-04-11 |
| MULTILASER SYSTEM (K123777) | Ultralight Laser Technologies, LLC | 2013-04-11 |
| TK1 TOTAL KNEE SYSTEM (K123339) | Novosource, Inc. | 2013-04-11 |
| MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS (K130813) | Mentor Corp. | 2013-04-11 |