| NB3D BONE VOID FILLER (K132050) | Pioneer Surgical Technology, Inc. | 2014-02-07 |
| FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL (K130723) | Famidoc Technology Co., Ltd. | 2014-02-07 |
| QUANTA FLASH CENTROMERE (K123880) | Inova Diagnostics, Inc. | 2014-02-07 |
| MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT (K133552) | Hansen Medical | 2014-02-07 |
| TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM (K131966) | Twin Star Medical, Inc. | 2014-02-07 |
| SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM (K132650) | Huntleigh Healthcare Limited | 2014-02-07 |
| ECLIPSE TREATMENT PLANNING SYSTEM (K133247) | Varian Medical Systems, Inc. | 2014-02-07 |
| C-MAX+ (PLUS) (K130864) | Aat Alber Antriebstechnik GmbH | 2014-02-06 |
| AIRSTRIP REMOTE PATIENT MONITORING (K133394) | Airstrip Technologies, LP | 2014-02-06 |
| INTEGRITY SPINAL CARE SYSTEM 3.0 (K130249) | Integrity Life Sciences | 2014-02-06 |
| APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH (K140036) | Aptus Endosystems, Inc. | 2014-02-06 |
| ALIVECOR HEART MONITOR OTC (K130921) | AliveCor, Inc. | 2014-02-06 |
| STAPIX SUPERELASTIC IMPLANT BONE STAPLES (K133523) | Instratek, Inc. | 2014-02-06 |
| VDRIVE WITH V-SONO (K133396) | Stereotaxis, Inc. | 2014-02-06 |
| POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K131341) | Shijiazhuang Winful Plastic Co., Ltd. | 2014-02-06 |
| NUVANT MCT SYSTEM (K133701) | Corventis, Inc. | 2014-02-06 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130890) | Air Plastic Co., Ltd. | 2014-02-06 |
| CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION (K132824) | Carestream Health, Inc. | 2014-02-06 |
| FUSE 1C COLONOSCOPY SYSTEM (K132839) | Endochoice, Inc. | 2014-02-06 |
| DUAL ENERGY SYSTEM PACKAGE (K132813) | Toshibamedical Systems Corporation | 2014-02-06 |
| VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT (K133550) | Maine Standards Company, LLC | 2014-02-05 |
| SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) (K133867) | Terumo Europe N.V. | 2014-02-05 |
| SONILASE LIGHT THERAPY DEVICE (K132613) | Biorenew Labs, LLC | 2014-02-05 |
| ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY (K133601) | Siemens Healthcare Diagnostics, Inc. | 2014-02-05 |
| CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER (K140015) | Cardiosolutions, Inc. | 2014-02-05 |
| RT016 INSPIRATORY FILTER (K133666) | Fisher & Paykel Healthcare, Ltd. | 2014-02-05 |
| POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130582) | Heze City Green Food Co., Ltd. | 2014-02-04 |
| GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER (K132383) | Gyrus Acmi, Inc. | 2014-02-04 |
| LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (K131653) | Lin-Zhi International, Inc. | 2014-02-04 |
| SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM (K132886) | Smith & Nephew, Inc. | 2014-02-04 |
| BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW (K130320) | Covidien | 2014-02-04 |
| 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 (K133794) | Depuy Mitek, A Johnson & Johnson Company | 2014-02-04 |
| DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER (K132140) | Duteck Industrial Co., Ltd. | 2014-02-04 |
| STREAMLINE EXPRESS (K132602) | Nxstage Medical, Inc. | 2014-02-04 |
| ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION (K133737) | Zimmer, Inc. | 2014-02-04 |
| GFS II STANDARD, GFS II LARGE, GFS MIMI (K133757) | Parcus Medical, LLC | 2014-02-04 |
| ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (K131249) | I-Flow, LLC | 2014-02-03 |
| JULIET LL LATERAL LUMBAR CAGE (K133557) | Spineart | 2014-02-03 |
| DEROYAL SPINE SPACER SYSTEM (K131292) | Deroyal Industries, Inc. | 2014-02-03 |
| SHOOCIN INTRODUCER KIT (K123475) | Lepu Medical Technology (Beijing) Co., Ltd. | 2014-02-03 |
| SARNS HIGH FLOW AORTIC ARCH CANNULA (K133151) | Terumo Cardiovascular Systems Corp. | 2014-02-03 |
| MEDLINE SHARPS CONTAINER (K132767) | Medline Industries, Inc. | 2014-02-03 |
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K132221) | Shandong Haoyu Medical Products Co., Ltd. | 2014-01-31 |
| VESALIUS (K131696) | Telea Electronic Engineering Srl | 2014-01-31 |
| VARIAN MULTILEAF COLLIMATOR (K133240) | Varian Medical Systems, Inc. | 2014-01-31 |
| 6MP COLOR LCD MONITOR, RADIFORCE RX650 (K134002) | Eizo Corporation | 2014-01-31 |
| CO PILOT/REGIUS UNITEA (K133730) | Konica Minolta, Inc. | 2014-01-31 |
| LINA GOLD LOOP HC (K132135) | Lina Medical Aps | 2014-01-31 |
| LOGIQ F SERIES (K133034) | GE Healthcare | 2014-01-31 |
| RADIANCE V2 (K133655) | Gmv Soluciones Globales Internet S.A.U. | 2014-01-31 |
| AVD RIGHT RADIAL DRAPE (K131571) | Advanced Vascular Dynamics | 2014-01-31 |
| XIRALITE FLOURESCENCE IMAGING SYSTEM X4 (K130003) | Mivenion GmbH | 2014-01-31 |
| BREEZY ELEGANCE (K133855) | Sunrise Medical (Us), LLC | 2014-01-31 |
| RAYPEX 6 (K131907) | Dentsply International, Inc. | 2014-01-31 |
| MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) (K132807) | Welch Allyn, Inc. | 2014-01-31 |
| SENSITITRE YEASTONE SUSCEPTIBILITY PLATES (K133038) | Trek Diagnostic Systems | 2014-01-31 |
| ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER (K132792) | Daniels Sharpsmart, Inc. | 2014-01-31 |
| ENLIGHTN RENAL GUIDE CATHETER (K131592) | St. Jude Medical, Inc. | 2014-01-31 |
| WONDFO RAPID STREP A TEST (K133343) | Guangzhou Wondfo Biotech Co., Ltd. | 2014-01-31 |
| INTERBODY CAGE SYSTEM (K133967) | Aurora Spine | 2014-01-31 |
| MEDSOURCE IV SAFETY CATHETER (K131555) | Medsource International, LLC | 2014-01-31 |
| SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST (K132356) | Scican GmbH | 2014-01-31 |
| SORIN FLEXTHERM (K140012) | Sorin Group Deutschland GmbH | 2014-01-31 |
| NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM), (K133796) | Marvao Medical Devices, Ltd. | 2014-01-31 |
| VITA SUPRINITY(R) (K132070) | Vita Zahnfabrik H.Rauter GmbH & Co. | 2014-01-31 |
| CENTURION POCT SYSTEM (K131833) | Orthofix, Inc. | 2014-01-30 |
| ARDIS INTERBODY SYSTEM (K133184) | Zimmer Spine, Inc. | 2014-01-30 |
| POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K131344) | Shijiazhuang Wally Plastics Co., Ltd. | 2014-01-30 |
| MECTALIF TIPEEK (K133192) | Medacta International | 2014-01-30 |
| DIGITAL ELECTROCARDIOGRAPH (K132758) | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2014-01-30 |
| CRUX SNARE FILTER RETRIEVAL SET (K133681) | Volcano Corporation | 2014-01-30 |
| NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION (K132746) | Nobel Biocare USA, LLC | 2014-01-30 |
| UV PHOTOTHERAPY (K132643) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2014-01-30 |
| MINI TIGHTROPE (K133275) | Arthrex, Inc. | 2014-01-30 |
| DOME S10 (K132770) | Nds Surgical Imaging | 2014-01-30 |
| TITANIUM SUTURE ANCHOR (K133229) | Mtp Solutions, LLC | 2014-01-30 |
| CARDIOCEL (K130872) | Celxcel Pty, Ltd. | 2014-01-30 |
| CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER (K132474) | Acist Medical Systems | 2014-01-30 |
| ARTHREX BIOSUTURE (K140019) | Arthrex, Inc. | 2014-01-30 |
| GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM (DEN120023) | Given Imaging , Ltd. | 2014-01-29 |
| AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL (K133176) | Ciba Vision Corporation | 2014-01-29 |
| TANDEMHEART FEMORAL VENOUS CANNULA SET (K133236) | Cardiacassist, Inc. | 2014-01-29 |
| ADVANCE CS CORONARY SINUS INFUSION CATHETER (K131204) | Cook, Inc. | 2014-01-29 |
| MOORLDLS-BI LASER DOPPLER BURNS IMAGER (K132163) | Moor Instruments, Ltd. | 2014-01-29 |
| UA-CELLULAR COMPLETE (K131444) | Streck | 2014-01-29 |
| SPIWAY ENDONASAL ACCESS GUIDE (K132721) | Spiway, LLC | 2014-01-29 |
| CADWELL FLEX EEG/PSG (K133355) | Cadwell Industries, Inc. | 2014-01-29 |
| EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM (K133541) | Emerge Medical | 2014-01-28 |
| PROSTATE IMMOBILIZER RECTAL BALLOON (DEN130036) | Radiadyne | 2014-01-28 |
| GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT (K131330) | Gold Standard Diagnostics | 2014-01-28 |
| XTRAFIX SMALL EXTERNAL FIXATION SYSTEM (K131413) | Zimmer, Inc. | 2014-01-28 |
| OTC PATCH (K133723) | Well-Life Healthcare Limited | 2014-01-28 |
| AVERSION PEDICLE SCREW SYSTEM (K133103) | K7, LLC | 2014-01-27 |
| DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE (K132638) | Siemens Healthcare Diagnostics, Inc. | 2014-01-27 |
| PERI-PROSTHETIC CABLE SYSTEM (K133354) | Biomet, Inc. | 2014-01-27 |
| SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ (K131309) | Ibramed Equipamentos Medicos | 2014-01-27 |
| 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY (K133986) | Resonance Innovations, LLC | 2014-01-27 |
| ATAMA SYSTEM (K132444) | Monteris Medical, | 2014-01-27 |
| ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET (K131244) | Roche Diagnostics | 2014-01-27 |
| 4D INTEGRATED TREATMENT CONSOLE (K133331) | Varian Medical Systems, Inc. | 2014-01-27 |