| CARRICELL (K132868) | Etex Corporation | 2015-02-20 |
| FIBERION OPHTHALMIC ENDOLASER PROBE (K133019) | Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim | 2015-02-20 |
| NeedleCam HD Visualization System (K143705) | Biovision Technologies, LLC | 2015-02-20 |
| Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) (K143431) | I-Codi Co., Ltd. | 2015-02-20 |
| NuVasive X-CORE(R) Expandable VBR System (K142205) | Nuvasive, Inc. | 2015-02-20 |
| 3S Safety Syringe with/without Needle (K142435) | Sincere Medical Device Co., Ltd. | 2015-02-20 |
| Fingertip Pulse Oximeter (K142888) | Beijing Choice Electronic Technololgy Co., Ltd. | 2015-02-20 |
| Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope (K142248) | Urologix, Inc. | 2015-02-20 |
| MEDENTIKA ABUTMENT SYSTEM (K142167) | Medentika GmbH | 2015-02-20 |
| StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit (K142432) | Bioness, Inc. | 2015-02-20 |
| KINETIS Total Knee System (K143635) | Mako Surgical | 2015-02-20 |
| EASY OUT (K141401) | Feet For Life Podiatry Center | 2015-02-20 |
| Terason uSmart3300 Ultrasound System (K150148) | Teratech Corp. | 2015-02-20 |
| U50 Diagnostic Ultrasound System (K142511) | Edan Instruments, Inc. | 2015-02-20 |
| IntelliSense Drill (K143191) | Mcginley Innovations | 2015-02-20 |
| ZywieAI Software Library (K142693) | Zywie, Inc. | 2015-02-20 |
| Volcano iFR Harvest Software (Offline) (K143122) | Volcano Corporation | 2015-02-20 |
| Spring Coil Guidewire (K143135) | Neometrics, Inc. | 2015-02-20 |
| Bissinger Monopolar Cables (K150024) | Guenter Bissinger Medizintechnik GmbH | 2015-02-20 |
| StaXx(R) XD System (K142996) | Spine Wave, Inc. | 2015-02-19 |
| 3S Safety Insulin Syringe (K142436) | Sincere Medical Device Co., Ltd. | 2015-02-19 |
| FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 (K143005) | Biofire Diagnostics, LLC | 2015-02-19 |
| BUSSE EXTENSION SET (K141285) | Busse Hospital Disposables | 2015-02-19 |
| GM60A-32S & GM60A-40S (K150097) | Samsung Electronics Co., Ltd. | 2015-02-19 |
| 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) (DEN140044) | 23AndMe | 2015-02-19 |
| Vienna System (K142597) | Mick Radio-Nuclear Instruments, Inc. | 2015-02-19 |
| Osstell IDx (K142358) | Osstell AB | 2015-02-19 |
| NeuroBlate System (K143457) | Monteris Medical, Inc. | 2015-02-19 |
| Codman Certas Plus Programmable Valve; Codman Certas Toll Kit (K143111) | Medos International SARL | 2015-02-19 |
| SYPHER SPACER SYSTEM (K141798) | Biogennix, LLC | 2015-02-19 |
| ORAGENE DX OGD-500.001 (K141410) | DNA Genotek, Inc. | 2015-02-19 |
| Checkpoint, Checkpoint Head & Neck (K150005) | Ndi Medical, LLC | 2015-02-19 |
| LYNC intramedullary implant (K143049) | Novastep | 2015-02-19 |
| Sensititre Susceptibility Plates (K143381) | Thermo Fisher Scientific | 2015-02-19 |
| Lubrigyn cream (K150147) | Uniderm Farmaceutici Srl | 2015-02-19 |
| E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER (K141587) | Megadyne Medical Products, Inc. | 2015-02-18 |
| SATURN 5 LASER (K141434) | Research Instruments , Ltd. | 2015-02-18 |
| BODY COMPOSITION ANALYZER (K140045) | Jawon Medical Co., Ltd. | 2015-02-18 |
| Optima XR646 (K143270) | Ge Hualun Medical Systems Co. , Ltd. | 2015-02-18 |
| Polysmith Sleep System (K142774) | Neurotronics, Inc. | 2015-02-18 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K150246) | Medtronic, Inc. | 2015-02-18 |
| Master Caution Device MCD (K142476) | Healthwatch , Ltd. | 2015-02-17 |
| NUROS BONE GRAFT SUBSTITUTE (K140913) | Oriental Resources Development Limited | 2015-02-17 |
| LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA (K142991) | Life Global Group, LLC | 2015-02-17 |
| FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System (K143080) | Biofire Diagnostics, LLC | 2015-02-17 |
| CONELOG Titanium base CAD/CAM (K143337) | Altatec GmbH | 2015-02-17 |
| MEDEOR MATRIX WOUND DRESSING (K141738) | Kensey Nash Corporation Dba Dsm Biomedical | 2015-02-17 |
| Klassic Knee System-Sombrero Patella (K150105) | Total Joint Orthopedics, Inc. | 2015-02-17 |
| Maxima XTEND Handpiece Maintenance System (K143183) | Handpiece Headquarters | 2015-02-17 |
| LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 (K141205) | Lin-Zhi International, Inc. | 2015-02-13 |
| PuraDerm Gel (K143058) | 3-D Matrix, Inc. | 2015-02-13 |
| Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff (K142298) | Covidien | 2015-02-13 |
| QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. (K141274) | Inova Diagnostics, Inc. | 2015-02-13 |
| DIGITAL ELECTROCARDIOGRAPH (K141946) | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-02-13 |
| CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments (K143375) | Medtronic Sofamor Danek USA, Inc. | 2015-02-13 |
| TOMTEC-ARENA TTA2 (K150122) | Tomtec Imaging Systems GmbH | 2015-02-13 |
| Neuwater TM (HydrocynTM aqua) (K142775) | Vigilenz Medical Devices | 2015-02-13 |
| ivWatch Model 400 (K142374) | Ivwatch, LLC | 2015-02-13 |
| ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 (K141375) | Phadia US, Inc. | 2015-02-13 |
| COGNISION EEG/EP SYSTEM (K141316) | Neuronetrix Solutions | 2015-02-13 |
| DMRC Dual Cure Orthodontic Band Cement (K142881) | Danville Materials, LLC | 2015-02-13 |
| Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family (K142924) | Shaser, Inc. | 2015-02-13 |
| GALILEO NT (K142064) | Eb Neuro S.P.A. | 2015-02-13 |
| SEEGENE ANYPLEX II HSV-1/2 ASSAY (K142156) | Seegene | 2015-02-13 |
| CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style (K143127) | Dispo-Med (Malaysia) Sdn Bhd | 2015-02-13 |
| Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens (K143632) | Bausch & Lomb, Incorporated | 2015-02-13 |
| DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS (K140881) | Depuy(Ireland) | 2015-02-13 |
| ECLIPSE SYSTEM (DEN140020) | Pelvalon | 2015-02-12 |
| Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (K143131) | Kossan International Sdn Bhd | 2015-02-12 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR (K134046) | Fukuda Denshi USA, Inc. | 2015-02-12 |
| CD HORIZON Spinal System (K143569) | Medtronic Sofamor Danek USA, Inc. | 2015-02-12 |
| NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM (K141222) | Life Spine, Inc. | 2015-02-12 |
| Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) (K143297) | Zimmer Spine, Inc. | 2015-02-12 |
| Navigated Vertex Select Instruments (K143628) | Medtronic Sofamor Danek USA, Inc. | 2015-02-12 |
| Vanguard 360 Revision Knee System (K143192) | Biomet, Inc. | 2015-02-12 |
| Visionaire Disposable Instruments (K143226) | Smith & Nephew, Inc. | 2015-02-12 |
| QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS (K141328) | Inova Diagnostics, Inc. | 2015-02-12 |
| IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY (K141803) | Immunalysis Corporation | 2015-02-12 |
| Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla (K143055) | Yty Industry (Manjung) Sdn Bhd | 2015-02-12 |
| PedFuse Pedicle Screw System (K143377) | Spinefrontier, Inc. | 2015-02-12 |
| TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS (K133268) | Schutz-Dental GmbH | 2015-02-12 |
| Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 (K143302) | Cepheid | 2015-02-12 |
| INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF (K141087) | Intersurgical Incorporated | 2015-02-12 |
| PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT (K140900) | Stanmore Worldwide Implants , Ltd. | 2015-02-12 |
| SOFTECH Plus ETCO2 Cannula (K143469) | Teleflexmedical, Inc. | 2015-02-12 |
| DD Bio Z, DD Bio ZX(square), DD BioZX(square) color (K142987) | Dental Direkt of Amerika UG (Haftungsbeschraenkt) | 2015-02-11 |
| CD HORIZON SPINAL SYSTEM (K150178) | Medtronic Sofamor Danek USA, Inc. | 2015-02-11 |
| Tensyn Plug (K143092) | Dallen Medical, Inc. | 2015-02-11 |
| NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE (K142685) | Siam Sempermed Corp., Ltd. | 2015-02-11 |
| VCARE (K142716) | Conmed Corporation | 2015-02-10 |
| G7 Freedom and Offset Liners, Freedom Head, Size 32 (K142882) | Biomet, Inc. | 2015-02-10 |
| MICRONAIL Distal Radius System (K150073) | Wrightmedicaltechnologyinc | 2015-02-10 |
| TI NASAL MASK (K140980) | Respironics, Inc. | 2015-02-10 |
| Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems (K142472) | GE Healthcare | 2015-02-10 |
| PASS LP Spinal System (K150049) | Medicrea International | 2015-02-10 |
| BIOS KING BIOCELLULOSE FILM (K141382) | Coreleader Biotech Co., Ltd. | 2015-02-10 |
| STERISPINE PS Pedicle Screw (K150092) | Safe Orthopaedics | 2015-02-10 |
| OPTIMUS NEURO SYSTEM (K141911) | Osteonic Co., Ltd. | 2015-02-10 |
| PMMA BLOCK (K141421) | Rizhao Huge Dental Industry Co., Ltd. | 2015-02-09 |
| Excia Total Hip System (K150062) | Aesculap Implant Systems, LLC | 2015-02-09 |