| ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K140948) | Spineart | 2014-05-20 |
| OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE (K133082) | Osteosymbionics, LLC | 2014-05-20 |
| OSTEOSPAN MORPHEUS (K132377) | Biogennix, LLC | 2014-05-20 |
| PRIME ZOOM STRETCHER (K140095) | Stryker Corporation | 2014-05-20 |
| VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) (K122556) | Leica Biosystems Newcastle, Ltd. | 2014-05-19 |
| DMS 300-2W HOLTER ECG RECORDER (K133014) | Diagnostic Monitoring Software | 2014-05-19 |
| INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT (K141015) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2014-05-19 |
| CS2 MULTI-HOLE ACETABULAR SHELL (K141043) | Consensus Orthopedics, Inc. | 2014-05-19 |
| THUNDERBEAT (K132703) | Olympus Medical Systems Corp. | 2014-05-19 |
| PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE (K133793) | Persyst Development Corporation | 2014-05-19 |
| MAXIO (K132108) | Perfint Healthcare Pvt, Ltd. | 2014-05-19 |
| VIEWFLEX XTRA ICE CATHETER (K133853) | Irvine Biomedical, Inc., A St. Jude Medical Company | 2014-05-19 |
| NXSTAGE SYSTEM ONE (K140526) | Nxstage Medical, Inc. | 2014-05-19 |
| VSCAN WITH DUAL PROBE (K140693) | Ge Medical Sysyems Ultrasound & Primary Care Diagn | 2014-05-16 |
| TEMPUS PRO EXTENDED FEATURES (K133988) | Remote Diagnostic Technologies , Ltd. | 2014-05-16 |
| BIOPSY PIPETTES (K133257) | Research Instruments , Ltd. | 2014-05-16 |
| APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE (K141041) | Aptus Endosystems | 2014-05-16 |
| AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM (K131096) | Arobella Medical, LLC | 2014-05-16 |
| VITAL SIGNS MONITOR (K132037) | Mindray North America | 2014-05-16 |
| CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR (K133519) | Carolina Liquid Chemistries Corp. | 2014-05-16 |
| AXERA RX ACCESS SYSTEM (K140287) | Arstasis, Inc. | 2014-05-16 |
| LUMENA FH HAIR REMOVAL SYSTEM (K140631) | Shaser, Inc. | 2014-05-16 |
| RESCAN (K140054) | Resmed, Ltd. | 2014-05-16 |
| NUVASIVE NVM5 SYSTEM (K132694) | Nu Vasive, Incorporated | 2014-05-16 |
| KLASSIC KNEE TIBIAL STEM EXTENSION (K140942) | Total Joint Orthopedics, Inc. | 2014-05-16 |
| EXTRICARE (K132225) | Devon Medical, Inc. | 2014-05-15 |
| XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK (K130915) | Jas Diagnostics, Inc. | 2014-05-15 |
| XGEO GR40CW (K140235) | Samsung Electronics Co., Ltd. | 2014-05-15 |
| 6VT-D ULTRASOUND TRANSDUCER (K141093) | Ge Vingmed Ultrasound AS | 2014-05-15 |
| SALVATION BEAMS AND BOLTS SYSTEM (K140741) | Wrightmedicaltechnologyinc | 2014-05-15 |
| SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM (K133763) | Medi-Globe Corporation | 2014-05-15 |
| FETAL MONITORS (K131941) | Guangdong Biolight Meditech Co., Ltd. | 2014-05-15 |
| RXG DISTRACTION SYSTEM (K133304) | KLS-Martin L.P. | 2014-05-15 |
| RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT (K140329) | Boston Scientific | 2014-05-15 |
| INFUSET FLOW CONTROL EXTENSION SET (K140133) | Emed Technologies Corporation | 2014-05-15 |
| CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW (K140952) | Wrightmedicaltechnologyinc | 2014-05-15 |
| ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS (K133664) | Ge Medical Systems Ultrasound & Primary Care Diagn | 2014-05-15 |
| RAY STATION (K140187) | Raysearch Laboratories AB | 2014-05-15 |
| FIREFLY (K134001) | Firstkind Limited | 2014-05-15 |
| NXSTAGE PUREFLOW SL (K140571) | Nxstage Medical, Inc. | 2014-05-15 |
| SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICLEAN MOLAR PROCEDURE KIT (K133752) | Sonendo, Inc. | 2014-05-15 |
| SMITH & NEPHEW CANNULATED CAPTURED SCREW (K133662) | Smith & Nephew, Inc. | 2014-05-15 |
| CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM (K133620) | Imaging Sciences International | 2014-05-14 |
| STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) (K140255) | Pollogen, Ltd. | 2014-05-14 |
| SALVATION OSTEOPENIC SCREW (K140408) | Wrightmedicaltechnologyinc | 2014-05-14 |
| MSP METATARSAL SHORTENING SYSTEM (K140724) | Nextremity Solutions, Inc. | 2014-05-14 |
| BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR (K140591) | Becton, Dickinson & CO | 2014-05-14 |
| QUICKSCREEN AMPHETINE 500 TEST (K131069) | Phamatech, Inc. | 2014-05-14 |
| MULTIFIX S KNOTLESS FIXATION SYSTEM (K140604) | ArthroCare Corporation | 2014-05-14 |
| OMNIPORE CUSTOMIZED SURGICAL IMPLANTS (K133046) | Matrix Surgical Holdings, LLC/Matrix Surgical USA | 2014-05-14 |
| ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO (K133912) | Origio A/S | 2014-05-14 |
| NEOPLATE SPINE ANTERIOR FIXATION SYSTEM (K132653) | Neoortho Productos Orthopedicos S/A | 2014-05-14 |
| ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS (K133700) | Boston Scientific Corporation | 2014-05-14 |
| SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM (K133153) | Spinefrontier, Inc. | 2014-05-14 |
| M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM (K141010) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014-05-14 |
| EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL (K130080) | Medica Corporation | 2014-05-13 |
| CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT (K140568) | Facet Technologies, LLC | 2014-05-13 |
| DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A (K140060) | Rayence Co., Ltd. | 2014-05-13 |
| EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) (K132899) | Equashield Medical , Ltd. | 2014-05-13 |
| VERSACUT + TISSUE MORCELLATOR (K133272) | Lumenis, Ltd. | 2014-05-13 |
| DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A (K140056) | Rayence Co., Ltd. | 2014-05-13 |
| PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX (K133317) | Penumbra, Inc. | 2014-05-13 |
| ONE-PIECE PEEK FUSION IMPLANT (K140970) | Mtp Solutions, LLC | 2014-05-13 |
| VITREA IMAGE DENOISING SOFTWARE (K140395) | Vital Images, Inc. | 2014-05-13 |
| AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP (K140343) | Aesculap, Inc. | 2014-05-13 |
| DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE (K140622) | Biomet, Inc. | 2014-05-13 |
| BIOMARC COAXIAL NEEDLE (K133148) | Carbon Medical Technologies, Inc. | 2014-05-13 |
| Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM (K133206) | Zuma Dental, LLC | 2014-05-13 |
| QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY (DEN140004) | Diagnostic Hybrids, Inc. | 2014-05-13 |
| IMDX HSV-1/2 FOR ABBOTT M2000 (K140198) | Intelligent Medical Devices, Inc. | 2014-05-13 |
| GALLIEON-1 MEDICAL LASER (K132529) | Future Device and Technology, Inc. | 2014-05-12 |
| AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE (K132686) | Degania Silicone , Ltd. | 2014-05-12 |
| 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL (K140606) | Resonance Innovations, LLC | 2014-05-12 |
| ROSS RU SKIN DISCONTINUITIES (K131176) | Biotd S.A. | 2014-05-12 |
| ENDOSEAL (K133054) | Maruchi | 2014-05-12 |
| TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE (K131531) | Anhui Tiankang Medical Products Co., Ltd. | 2014-05-12 |
| S9 ELOUERA (K140124) | Resmed Corp | 2014-05-12 |
| ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM (K133378) | Zimmer, Inc. | 2014-05-12 |
| ZERONA (K133718) | Erchonia Corporation | 2014-05-12 |
| SUPERCATH5 (K140419) | Togo Medikit Co., Ltd. | 2014-05-12 |
| ENDOCEM ZR (K133042) | Maruchi | 2014-05-12 |
| RITTER IMPLANT SYSTEM (K131557) | Ritter Implants GmbH CO KG | 2014-05-09 |
| A9800 ANESTHESIA WORKSTATION (K131790) | Oricare, Inc. | 2014-05-09 |
| SINGLE-SITE PORT (K133203) | Intuitive Surgical, Inc. | 2014-05-09 |
| ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG (K140354) | Abbott Molecular, Inc. | 2014-05-09 |
| CANDELA GENTLEMAX FAMILY OF LASER SYSTEM (K140122) | Candela Corp. | 2014-05-09 |
| ADX4000W (K134055) | Dexcowin Co., Ltd. | 2014-05-09 |
| DEKA ARM SYSTEM (DEN120016) | Deka Integrated Solutions Corporation | 2014-05-09 |
| BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM (K133251) | C.R. Bard, Inc. | 2014-05-09 |
| YZ3 PORTABLE SLIT LAMP (K131711) | Suzhou 66 Vision Tech Co., Ltd. | 2014-05-09 |
| LEKSELL GAMMA KNIFE PERFEXION (K133565) | Elekta Instrument AB | 2014-05-09 |
| PIXEL 3 SYSTEM (DEN130015) | Gauss Surgical, Inc., | 2014-05-09 |
| DUET SYSTEM (K130775) | Bioview , Ltd. | 2014-05-09 |
| 16 CH MULTIPURPOSE COIL VARIETY (K140252) | Noras Rontgen-Und Medizintechnik GmbH | 2014-05-08 |
| CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (K132711) | Carolina Liquid Chemistries Corp. | 2014-05-08 |
| MRNA APPLIANCE (K130067) | Biomodeling Solutions, Lls | 2014-05-08 |
| ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS (K140755) | Medical Compression Systems (Dbn) , Ltd. | 2014-05-08 |
| ASTHMA MONITOR AM3 (K133722) | Eresearch Technology | 2014-05-08 |
| NOBELACTIVE WIDE PLATFORM (WP) (K133731) | Nobel Biocare AB | 2014-05-08 |
| FILTEK BULK FILL POSTERIOR RESTROATIVE (K141081) | 3M Espe Dental Products | 2014-05-08 |