| AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM (K142124) | Aseptico, Inc. | 2014-12-31 |
| PK Spatula (K142289) | Gyrus Acmi, Inc. | 2014-12-31 |
| TYRX Neuro Absorbable Antibacterial Envelope (K142611) | Medtronic Tyrx, Inc. | 2014-12-31 |
| LITe Plate System (K142699) | Stryker Corporation | 2014-12-31 |
| AEx Generator; PlasmaBlade T (K143175) | Medtronic Advanced Energy | 2014-12-31 |
| UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT (K133333) | Blue Ocean Medical Product, LLC | 2014-12-31 |
| OWL CANNULAE (K141586) | Diros Technology, Inc. | 2014-12-30 |
| 3.Omm Biomet Cannulated Screw System (K143188) | Biomet Manufacturing Corp | 2014-12-30 |
| TRIA FANP (K141868) | Tria Beauty, Inc. | 2014-12-30 |
| NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (K142173) | Ecolab, Inc. | 2014-12-30 |
| ACROSSPINE PEDICLE SCREW SYSTEM (K141695) | Arthro-Dif | 2014-12-30 |
| MICROBLAB, MICROLOOP (K141936) | Carefusion Germany 234 GmbH | 2014-12-29 |
| G7 Finned Acetabular Shell (K142746) | Biomet Manufactuting Corp. | 2014-12-29 |
| AQUARIUS Gastrostomy Replacement Tube (K143378) | Degania Silicone , Ltd. | 2014-12-29 |
| VECTRIX EXTERNAL FIXATOR (K140649) | 3D Medical Concepts, LLC | 2014-12-29 |
| HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES (K141878) | Tangshan Hongyun Plastic Products Co., Ltd. | 2014-12-24 |
| Straight Stud Attachment (K142407) | Sterngold Dental, LLC | 2014-12-24 |
| MIDI-SRS (K141046) | Srmc Co., Ltd. | 2014-12-24 |
| CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable (K142429) | Codman & Shurtleff, Inc. | 2014-12-24 |
| IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material (K143352) | Siemens Healthcare Diagnostics, Inc. | 2014-12-24 |
| Burn Resuscitation Decision Support System - Clinical (BRDSS-C) (K140387) | The Surgeon General, Department of the Army | 2014-12-23 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K142151) | Thermo Fisher Scientific | 2014-12-23 |
| Biomet Tibial trays (K142933) | Biomet, Inc. | 2014-12-23 |
| HP Tissue Matrix (K142326) | Lifecell Corporation | 2014-12-23 |
| Wrist Hemiarthroplasty System (K141920) | Arthrosurface, Inc. | 2014-12-23 |
| nvc (K142328) | Nvision Biomedical Technologies, LLC | 2014-12-23 |
| ALIANS ULNA LOCKING PLATING SYSTEM (K142502) | Newclip Technics | 2014-12-23 |
| JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) (K142564) | JMS North America Corporation | 2014-12-23 |
| Klassic HD Hip System (K143407) | Total Joint Othopedics, Inc. | 2014-12-23 |
| KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS (K141479) | Covidien | 2014-12-23 |
| ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS (K140436) | Fujirebio Diagnostics,Inc. | 2014-12-23 |
| Instru-Safe Instrument Protection System (K142630) | Summit Medical, Inc. | 2014-12-23 |
| NExCT 7 (K142697) | Neurologica Corporation | 2014-12-23 |
| Nice1 (K143197) | Nice Recovery Systems, LLC | 2014-12-23 |
| TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 (K142427) | Applied Medical Resources | 2014-12-23 |
| ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material (K143376) | Siemens Healthcare Diagnostics, Inc. | 2014-12-23 |
| Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst (K142373) | Beckman Coulter, Inc. | 2014-12-22 |
| The Lipogems System (K142682) | Lipogems International Spa | 2014-12-22 |
| Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) (K143195) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014-12-22 |
| Carnation Ambulatory Monitor (K143067) | Bardy Diagnostics, Inc. | 2014-12-22 |
| Passage Hemostasis Valve (K143429) | Merit Medical Systems, Inc. | 2014-12-22 |
| BOVINE PERICARDIUM PATCH (K141721) | Collafirm, LLC | 2014-12-22 |
| Caspian OCT/MESA Mini/DENALI Mini Spinal System (K142558) | K2m | 2014-12-22 |
| Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) (K142391) | ACON Laboratories, Inc. | 2014-12-22 |
| Zimmer Persona Personalized Knee System (K142787) | Zimmer, Inc. | 2014-12-22 |
| AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm (K142528) | Agent Medical, LLC | 2014-12-22 |
| HEMASORBPLUS press Resorable Hemostatic Bone Putty (K143069) | Orthocon, Inc. | 2014-12-22 |
| AxSOS 3 Ti Locking Plate System (K143138) | Stryker Trauma AG | 2014-12-22 |
| POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE) (K140989) | Hebei Hongsen Plastics Technology Co, Ltd. | 2014-12-22 |
| Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K142771) | Xuanhua Metallurgical Industry Co., Ltd. | 2014-12-22 |
| SPEEDY FLAP SYSTEM (K130447) | Jeil Medical Corporation | 2014-12-22 |
| EVOTECH ECR (K140977) | Advanced Sterilization Products | 2014-12-22 |
| ANTHEM PS Total Knee System (K142807) | Smith & Nephew, Inc. | 2014-12-22 |
| The Optilite IgG3 kit (K142735) | The Binding Site Group , Ltd. | 2014-12-21 |
| ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) (K141161) | HORIBA ABX SAS | 2014-12-20 |
| Reform Pedicle Screw System (K143248) | Precision Spine, Inc. | 2014-12-19 |
| Powder Free Yellow Vinyl Patient Examination Gloves (K142508) | Zibo Huaqi Trading Co., Ltd. | 2014-12-19 |
| TurboSEAL Nasogastric Aspiration Tube (K142483) | Turboseal, L.P. | 2014-12-19 |
| Weck Hem-o-lok Auto Endo5 Ligating Clip Applier (K142777) | Teleflexmedical, Inc. | 2014-12-19 |
| Full Automatic (NIBP) Blood Pressure Monitor (K142968) | Health & Life Co., Ltd. | 2014-12-19 |
| IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET (K140554) | Immunodiagnostic Systems , Ltd. | 2014-12-19 |
| PK NEEDLE (K142154) | Gyrus Acmi, Inc. | 2014-12-19 |
| 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip (K143328) | Volcano Atheromed, Inc. | 2014-12-19 |
| Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (K141693) | Advanced Sterilization Products | 2014-12-19 |
| PLATINUMGMT IPL SYSTEM CLOUD (K140668) | Global Medical Technology S.L. | 2014-12-19 |
| AIS Odontoid Fracture Fixation System (K142707) | Aesculap Implant System, Inc. | 2014-12-19 |
| artus HSV-1/2 QS-RGQ MDx Kit (K142738) | Qiagen | 2014-12-19 |
| Zavation Z-Link Lumbar (K142271) | Zavation, LLC | 2014-12-19 |
| Connex Spot Monitor,901058 Vital Signs Monitor Core (K142356) | Welch Allyn, Inc. | 2014-12-19 |
| ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) (K142638) | Innovaquartz, LLC | 2014-12-19 |
| TrueBeam-TrueBeam STx-Edge (K143224) | Varian Medical Systems, Inc. | 2014-12-19 |
| Legacy BX (K142910) | Venus Concept USA, Inc. | 2014-12-19 |
| ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI (K133800) | Hgi Industires | 2014-12-19 |
| POROSTEON PHUSION METAL CERVICAL CAGE (K142041) | Porosteon, Inc. | 2014-12-19 |
| RhythmView Workstation (K142901) | Topera, Inc. | 2014-12-19 |
| LIFEPAK 15 monitor/defibrillator (K142430) | Physio-Control, Inc. | 2014-12-19 |
| Echotip Procore HD Ultrasound Biopsy Needle (K142688) | Cook Ireland, Ltd. | 2014-12-19 |
| ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE (K142111) | Novatsep | 2014-12-19 |
| VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) (K132407) | Lifewatch Technologies , Ltd. | 2014-12-19 |
| Hi-Torque JET Guide Wire Family (K142415) | Abbott Vascular, Inc. | 2014-12-19 |
| Bioceptive Suction Cervical Retractor (K142204) | Bioceptive, Inc. | 2014-12-19 |
| NORIS MEDICAL DENTAL IMPLANTS SYSTEM (K140440) | Noris Medical , Ltd. | 2014-12-19 |
| Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) (K143161) | Covidien | 2014-12-19 |
| Elecsys T-Uptake Calset (K143342) | Roche Diagnostics | 2014-12-19 |
| CytoSure Urinary Access System (K142194) | Emmy Medical | 2014-12-19 |
| AEROSURE MEDIC (K140772) | Actegy , Ltd. | 2014-12-19 |
| S12 Digital Color Doppler Ultrasound System (K142474) | Sonoscape Company Limited | 2014-12-19 |
| HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System (K142942) | Arthrosurface, Inc. | 2014-12-19 |
| Mini me (K143339) | Iluminage Ltd.(Formerly Syneron Beauty Ltd.) | 2014-12-19 |
| MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES (K142022) | Medline Renewal | 2014-12-19 |
| NXSTAGE SYSTEM ONE (K141752) | Nxstage Medical, Inc. | 2014-12-19 |
| INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM (K141926) | Medela AG | 2014-12-19 |
| InsufflatOR Needle (K142700) | Gynetech Pty. , Ltd. | 2014-12-19 |
| CPX Control Breast Tissue Expander (K142998) | Mentor Worldwide, LLC | 2014-12-19 |
| SMD Sr90-1 Radionuclide Brachytherapy Source (K142701) | Salutaris Medical Devices, Inc. | 2014-12-19 |
| FIRSTSTIC N INTRODUCER (K141969) | Argon Medical Devices, Inc. | 2014-12-19 |
| Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. (K142362) | Beckman Coulter, Inc. | 2014-12-19 |
| Interspinous Plate System (K142378) | Precision Spine, Inc. | 2014-12-18 |
| VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS (K141530) | Stereotaxis, Inc. | 2014-12-18 |
| Bio2 CLM BG Bioactive Scaffold (K142463) | Bio2 Technologies, Inc. | 2014-12-18 |