| MATRIXWAVE MMF SYSTEM (K141165) | Synthes (USA) Products, LLC | 2014-10-17 |
| ADVANTAGE (K141152) | Stevenson Industries, Inc. | 2014-10-17 |
| PARIETENE MACROPOROUS MESH (K142091) | Sofradim Production | 2014-10-17 |
| UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR (K141917) | Unicon Optical Co., Ltd. | 2014-10-17 |
| XprESS Multi-Sinus Dilation Tool (K142252) | Entellus Medical, Inc. | 2014-10-17 |
| Sherlock 3CG Tip Positioning System Stylet (K142267) | C.R. Bard, Inc. | 2014-10-17 |
| AERONEB SOLO; AERONEB SOLO ADAPTER (K133360) | Aerogen, Ltd. | 2014-10-17 |
| ELECSYS FOLATE III (K141426) | Roche Diagnostics | 2014-10-17 |
| Z1 CPAP SYSTEM (K140929) | Human Design Medical, LLC | 2014-10-17 |
| GLIDE DEVICE (K141242) | Home Skinovations , Ltd. | 2014-10-17 |
| T-PIECE RESUSCITATOR (K142096) | Mercury Medical | 2014-10-17 |
| Merit 10mL Syringe (K142636) | Merit Medical Systems, Inc. | 2014-10-17 |
| Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL (K142589) | Titan Spine, LLC | 2014-10-17 |
| CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT (K140581) | Cedic S.R.L. | 2014-10-17 |
| EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE (K141579) | Eco Medi Glove Sdn. Bhd. | 2014-10-17 |
| HALO AMBULATORY INFUSION SYSTEM (K140783) | Zyno Medical, LLC | 2014-10-17 |
| EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM (K141344) | Boston Scientific Corp | 2014-10-17 |
| BONASTENT TRACHEAL / BRONCHIAL (K140472) | Endochoice, Inc. | 2014-10-17 |
| Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System (K142618) | Hitachi Aloka Medical America, Inc. | 2014-10-16 |
| SYNGO CT SINGLE SOURCE DUAL ENERGY (K133677) | Siemens Medical Solutions USA, Inc. | 2014-10-16 |
| PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (K140598) | Dima Italia Srl | 2014-10-16 |
| ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM (K141584) | Boston Scientific Corporation | 2014-10-16 |
| Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) (K142280) | Healgen Scientific,, LLC | 2014-10-16 |
| G-Lok and G-Lok XL Extender (K142653) | T.A.G. Medical Products Corporation, Ltd. | 2014-10-16 |
| NDX DORSAL APPLIANCE (K133390) | Institute For Quality Resource Management | 2014-10-16 |
| ELEVATION (K140023) | Pdg Product Design Group, Inc. | 2014-10-16 |
| AQUARIUS NASAL FEEDING TUBE (K141753) | Degania Silicone , Ltd. | 2014-10-16 |
| HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM (K141801) | Covidien, LLC | 2014-10-16 |
| DX-D IMAGING PACKAGE (K142184) | Agfa Healthcare N.V. | 2014-10-16 |
| PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER (K140543) | Merit Medical Systems, Inc. | 2014-10-16 |
| PIEZOMED (K133488) | W&H Dentalwerk Buermoos GmbH | 2014-10-16 |
| STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES (K141776) | ETHICON, Inc. | 2014-10-15 |
| DANA (K141865) | Anthrotronix, Inc. | 2014-10-15 |
| AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES (K140025) | Pegavision Corporation | 2014-10-15 |
| RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM (K142095) | Renovis Surgical Technologies, Inc. | 2014-10-15 |
| COGENT MED-LIF XL (K142193) | Cogent Spine, LLC | 2014-10-15 |
| UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL (K134009) | Medtek Lighting | 2014-10-15 |
| XCEL 455 SLIT LAMP (K141954) | Reichert, Inc. | 2014-10-15 |
| OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER (K140470) | Oberon GmbH Fiber Technologies | 2014-10-15 |
| Urine/CSF Albumin, Urine/CSF Albumin Calibrator (K142346) | Beckman Coulter Ireland, Inc. | 2014-10-15 |
| MULTIPULSE HOPLUS (K131987) | Asclepion Laser Technologies GmbH | 2014-10-15 |
| INFLOW INTRAURETHRAL VALVE-PUMP (DEN130044) | Vesiflo, Inc. | 2014-10-14 |
| PICC Maximal Barrier Nursing Kit (K142616) | Navilyst Medical, Inc. | 2014-10-14 |
| JULIET PO (K142277) | Spineart | 2014-10-14 |
| QUANTRA (K142037) | Hologic, Inc. | 2014-10-10 |
| AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits (K142614) | AngioDynamics, Inc. | 2014-10-10 |
| HS NOTA (K131925) | H.S. Hospital Services S.P.A. | 2014-10-10 |
| VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) (K142033) | Nanospere,Inc. | 2014-10-10 |
| INTEGRA EXTERNAL FIXATION SYSTEM (K140463) | Ascension Orthopedic | 2014-10-10 |
| Acuson SC2000 Diagnostic Ultrasound System (K142628) | Siemens Medi Cal Solutions, Inc. | 2014-10-10 |
| ONESTEP CPR II MULTI-FUNCTION ELECTRODE (K133441) | Bio-Detek, Inc. | 2014-10-10 |
| EPIC 10 (K140120) | Biolase, Inc. | 2014-10-10 |
| QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT (K141869) | Hemedex Incorporated | 2014-10-10 |
| SOFIA DISTAL ACCESS CATHETER (K142014) | MicroVention, Inc. | 2014-10-10 |
| MECA XPRESSFISH (K140619) | Advandx, Inc. | 2014-10-10 |
| OSTOM-I ALERT (K140938) | 11 Health and Technologies, LLC | 2014-10-10 |
| Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System (K142323) | Ge Medical Systems Israel , Ltd. | 2014-10-10 |
| LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM (K142160) | GE Healthcare | 2014-10-10 |
| FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM (K141399) | Stimwave Technologies Incorporated | 2014-10-10 |
| FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM (K141106) | Folsom Metal Products, Inc. Dba Frontier Devices | 2014-10-10 |
| COROENT TI-C SYSTEM (K140319) | Nuvasive, Inc. | 2014-10-09 |
| ITCLAMP 50 (K140805) | Innovative Trauma Care, Inc. | 2014-10-09 |
| LYRA PARAINFLUENZA VIRUS ASSAY (K141927) | Quidel Corporation | 2014-10-09 |
| LYRA ADENOVIRUS ASSAY (K141931) | Quidel Corporation | 2014-10-09 |
| PRISM ZIRCONIA, ST-98 (K141659) | A & D Dental Innovations | 2014-10-09 |
| BLOOD PRESSURE MONITOR (K141416) | Shenzhen Pump Medical System Co., Ltd. | 2014-10-09 |
| Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests (K142396) | Chemtron Biotech, Inc. | 2014-10-09 |
| BIOMET FUSION SYSTEM (K141791) | Biomet Spine | 2014-10-09 |
| KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY (K141972) | Total Joint Orthopedics, Inc. | 2014-10-09 |
| FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET (K132592) | Cook, Inc. | 2014-10-09 |
| IEVA REHABILITATIVE POSITIONAL DEVICE (K133990) | Remendium Labs, LLC | 2014-10-09 |
| CLARITY (K141855) | Elekta , Ltd. | 2014-10-08 |
| MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra (K142515) | Siemens Medical Solutions USA, Inc. | 2014-10-08 |
| IDC INTERLOCKING DETACHABLE COIL (K141378) | Boston Scientific Corporation | 2014-10-08 |
| FLUOR PROTECTOR S (K131487) | Ivoclar Vivadent, AG | 2014-10-08 |
| GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM (K133245) | Genesys Spine | 2014-10-08 |
| A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR (K141201) | A & D Co., Ltd. | 2014-10-08 |
| LONG PULSE ND: YAG LASER SYSTEM (K140249) | Advanced Technology Laser Co., Ltd. | 2014-10-08 |
| NEEDLE VIEW CH SCOPE KITS (K141326) | Biovision Technologies, LLC | 2014-10-08 |
| THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL (K141456) | Fiagon GmbH | 2014-10-08 |
| BNX Fine Needle Aspiration System (K142198) | Covidien, LLC | 2014-10-08 |
| EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM (K141623) | Eco Medi Glove Sdn. Bhd. | 2014-10-07 |
| SIMPLY SLICK PERSONAL LUBRICATING LOTION (K140304) | Simply Solutions, LLC | 2014-10-07 |
| A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR (K141160) | A & D Co., Ltd. | 2014-10-07 |
| First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test (K142353) | W.H.P.M., Inc. | 2014-10-07 |
| Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens (K142275) | Neo Vision Co., Ltd. | 2014-10-07 |
| VASSEN COLOR (K141699) | Vassen Co., Ltd. | 2014-10-07 |
| EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) (K141510) | Eco Medi Glove Sdn. Bhd. | 2014-10-07 |
| 888 WNLE POWERED WHEELCHAIR (K142027) | Pihsiang Machinery Mfg. Co., Ltd. | 2014-10-07 |
| RESIDUAL LIMB LENGTHENING SYSTEM (K141739) | Ellipse Technologies, Inc. | 2014-10-07 |
| LED CURING LIGHT (K133040) | Monitex Industrial Co., Ltd. | 2014-10-07 |
| FLEX-MT + (K140467) | Emsi | 2014-10-07 |
| ULTRASHAPE SYSTEM (K141708) | Syneron Medical, Ltd. | 2014-10-06 |
| STARBAND, STARLIGHT (K141842) | Orthomerica Products, Inc. | 2014-10-06 |
| DIODE LASER HAIR REMOVAL SYSTEM (K141973) | Beijing Anchorfree Technology Co., Ltd. | 2014-10-06 |
| APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES (K141522) | Apex Medical Corp. | 2014-10-06 |
| LiNA SafeAir Smoke Pencil (K142538) | Lina Medical Aps | 2014-10-06 |
| NOVASHIELD INJECTABLE NASAL PACKING AND STENT (K141704) | Medtronic, Inc. | 2014-10-06 |
| SHARKCORE FINE NEEDLE BIOPSY SYSTEM (K141894) | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 2014-10-06 |
| 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) (K142540) | Jvckenwood Corporation | 2014-10-03 |