| MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture (K160854) | Biomet Manafacturing Corp. | 2016-12-19 |
| CustomizedBone Service (K160707) | Fin-Ceramica Faenza S.P.A. | 2016-12-17 |
| Dentium CAD/CAM Abutments (K161713) | Dentium Co., Ltd. | 2016-12-16 |
| NoCoding1 Plus Blood Glucose Monitoring System (K160742) | I-Sens, Inc. | 2016-12-16 |
| Chagas Detect Plus Rapid Test (K161947) | InBios International, Inc. | 2016-12-16 |
| COOLIEF Cooled Radiofrequency Kit (K163236) | Halyard Health, Inc. | 2016-12-16 |
| CleanCisionTM Wound Retraction and Protection System (DEN150038) | Prescient Surgical | 2016-12-16 |
| CETRA Anterior Cervical Plate System (K162638) | Orthofix, Inc. | 2016-12-16 |
| LC Bead LUMI (K162373) | Biocompatibles UK Limited | 2016-12-16 |
| Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit (K162161) | Stimwave Technologies Incorporated | 2016-12-16 |
| ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer (K161837) | Beckman Coulter, Inc. | 2016-12-16 |
| Revolution CT (K163213) | Ge Medical Systems, LLC | 2016-12-16 |
| Somatom Confidence ® RT Pro (K162302) | Siemens Medical Solutions USA, Inc. | 2016-12-16 |
| HyperView Hyperspectral Tissue Oxygenation Measurement System (K161237) | Hypermed Imaging, Inc. | 2016-12-16 |
| Zerona Z6 OTC (K162578) | Erchonia Corporation | 2016-12-16 |
| VITROS Chemistry Products Cl- Slides (K162020) | Ortho Clinical Diagnostics | 2016-12-16 |
| Xcite Clinical Station (K160614) | Restorative Therapies, Inc. | 2016-12-16 |
| xTAG Cystic Fibrosis 39 Kit v2 (K163347) | Luminex Molecular Diagnostics, Inc. | 2016-12-15 |
| 6MP Color LCD Monitor, RadiForce RX660, RX660-AR (K163335) | Eizo Corporation | 2016-12-15 |
| IPS e.max® Press Abutment Solutions for Viteo Base Ti (K160798) | Ivoclar Vivadent, AG | 2016-12-15 |
| Pulsaderm ACE-All Blue (K162371) | Nutra Luxe MD, LLC | 2016-12-15 |
| xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR (K163336) | Luminex Molecular Diagnostics, Inc. | 2016-12-15 |
| PERMATAPE (K162247) | Medos International SARL | 2016-12-15 |
| Zia (K160852) | Zetta Medical Technologies, LLC | 2016-12-15 |
| SMD-Sr90-DA Radionuclide Brachytherapy Source (K163206) | Salutaris Medical Devices, Inc. | 2016-12-15 |
| WS(TM) Far-Infrared Therapy Unit, Model KP-B210 (K160849) | Ws Far IR Medical Technology Co., Ltd. | 2016-12-15 |
| MRidium 3860+ MRI infusion Pump/ Monitoring System (K143369) | Iradimed Corporation | 2016-12-15 |
| ARIETTA Prologue Diagnostic Ultrasound system and Transducers (K162902) | Hitachi , Ltd. | 2016-12-15 |
| DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System (K162845) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016-12-15 |
| Menai System (K160836) | Resmed, Ltd. | 2016-12-15 |
| INTRABEAM 600 (K162568) | Carl Zeiss Meditec, AG | 2016-12-15 |
| BluePro (K162192) | Bluesom | 2016-12-15 |
| Arthrex iBalance UKA System Vitamin E Tibial Bearing (K161060) | Arthrex, Inc. | 2016-12-15 |
| Ritter Dental Implant System (K160475) | Ritter Implants GmbH & Co. KG | 2016-12-14 |
| GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) (K160412) | Instrumentation Laboratory CO | 2016-12-14 |
| Westmed Gas Sampling Cannula with O2 delivery (K162343) | Westmed, Inc. | 2016-12-14 |
| ENNOVATE Spinal System (K162134) | Aesculap Implant Systems, LLC | 2016-12-14 |
| Integrity-SI TM Fusion System (K161755) | Coorstek Medical | 2016-12-14 |
| XLTEK EMU40EX EEG Headbox (K163163) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-12-14 |
| Cryotec (K162051) | Reprolife, Inc. | 2016-12-14 |
| GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) (K160415) | Instrumentation Laboratory CO | 2016-12-14 |
| Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (K160915) | Roche Diagnostics | 2016-12-14 |
| GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator (K160225) | Instrumentation Laboratory CO | 2016-12-14 |
| Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete (K163200) | Boston Scientific Corporation | 2016-12-14 |
| GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) (K160402) | Instrumentation Laboratory CO | 2016-12-14 |
| SOVEREIGN® Spinal System (K162680) | Medtronic Sofamor Danek USA, Inc. | 2016-12-14 |
| PowerMidline Catheter (K162900) | C.R. Bard, Inc. | 2016-12-14 |
| OXINIUM DH Fermoral Heads (K161233) | Smith & Nephew, Inc. | 2016-12-14 |
| Emerge PTCA Dilatation Catheter (K163174) | Boston Scientific Corporation | 2016-12-14 |
| HPM-6000U (K162010) | BTL Industries, Inc. | 2016-12-13 |
| Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D (K160335) | St Jude Medical | 2016-12-13 |
| Matrix Pre-Treatment Controller (K161844) | Better Water, LLC | 2016-12-13 |
| Cloud Smart Thermometer (K160306) | Guangzhou Bosma Technology Co, Ltd. | 2016-12-13 |
| Carestream DRX-Evolution (K163203) | Carestream Health, Inc. | 2016-12-13 |
| MediGuide Technology System (K162643) | St Jude Medical | 2016-12-13 |
| Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter (K160941) | Brosmed Medical Co., Ltd. | 2016-12-13 |
| AutoMark Module (K160218) | St Jude Medical | 2016-12-13 |
| EnSite Precision Cardiac Mapping System v2.0 (K160210) | St Jude Medical | 2016-12-13 |
| Varian High Energy Linear Accelerator (K162476) | Varian Medical Systems, Inc. | 2016-12-12 |
| COUGAR® LS Lateral Cage System and COUGAR® System (K162327) | Medos International SARL | 2016-12-12 |
| Sysmex Automated Blood Coagulation Analyzer CS-5100 (K162420) | Siemens Healthcare Diagnostics Products GmbH | 2016-12-12 |
| PK AIM (K163373) | Gyrus Acmi, Inc. | 2016-12-12 |
| Photon, Photon Plus (K162114) | Zolar Technology & Mfg Co., Inc. | 2016-12-12 |
| ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 (K162442) | Gri Medical & Electrical Technology Co., Ltd. | 2016-12-12 |
| UC-5000 Mobile X-Ray (K163063) | Source-Ray, Inc. | 2016-12-12 |
| U-Blade Veress Needle (K162648) | Tianjin Uwell Medical Device Manufacturing Co., Ltd. | 2016-12-12 |
| InMode RF System (K163190) | Inmode MD , Ltd. | 2016-12-12 |
| neoBLUE compact LED Phototherapy System (K160745) | Natus Medical Incorporated | 2016-12-12 |
| ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler (K160969) | Shinemed, LLC | 2016-12-12 |
| STA® - Liatest® D-Di (K162227) | Diagnostica Stago | 2016-12-10 |
| Traxcess 7 Mini XSoft Guidewire (K163154) | MicroVention, Inc. | 2016-12-09 |
| HYPERION X5 (K161900) | Cefla S.C. | 2016-12-09 |
| EnFocus 2300, EnFocus 4400 (K162783) | Bioptigen, Inc. | 2016-12-09 |
| truSculpt (K162512) | Cutera, Inc. | 2016-12-09 |
| 16ch T/R Hand Wrist Coil (K162623) | Quality Electrodynamics, LLC | 2016-12-09 |
| BD Pen Needle (K162516) | Becton, Dickinson and Company | 2016-12-09 |
| Vanguard Dental Unit (K161734) | Ritter Concept GmbH | 2016-12-09 |
| Slit Lamp SL-D301 (K161972) | Topcon Corporation | 2016-12-09 |
| Contact Lens Case (K162869) | Ningbo Yinzhou Zonghai Artware Co., Ltd. | 2016-12-09 |
| Biomet Microfixation RibFix Blu Thoracic Fixation System (K162974) | Biomet Microfixation | 2016-12-09 |
| Jewel Precision Reusable Rigid Sterilization Container System (K162600) | Jewel Precision Sheet Metal & Machine, Inc. | 2016-12-09 |
| V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System (K160487) | Kci USA, Inc. | 2016-12-09 |
| Arc EndoCuff and Arc EndoCuff Vision (K162205) | Boddingtons Plastics, Ltd. | 2016-12-09 |
| Medline UNITE® Ankle Fracture Plating System (K162829) | Medline Industries, Inc. | 2016-12-09 |
| ProNova SC360 Proton Therapy System (K162246) | Pronova Solutions, LLC | 2016-12-08 |
| VIPER PRIME™ additions to the VIPER® System (K162912) | Medos International SARL | 2016-12-08 |
| FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) (K161632) | Bios S.R.L. | 2016-12-08 |
| Proture Double Electric Breast Pump (K162747) | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2016-12-08 |
| Stryker Universal Mesh (K161821) | Stryker | 2016-12-08 |
| Reprocessed Response Diagnostic Electrophysiology Catheters (K161827) | Innovative Health, LLC | 2016-12-08 |
| CAAS MR 4D Flow (K162376) | Pie Medical Imaging BV | 2016-12-08 |
| MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System (K162194) | Medicrea International SA | 2016-12-08 |
| Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (K162005) | Acuity Polymers, Inc. | 2016-12-08 |
| Wireless Digital Flat Panel Detector (K161730) | Iray Technology (Shanghai) , Ltd. | 2016-12-08 |
| DC-UIBC-CAL (K163078) | Sekisui Diagnostics P.E.I., Inc. | 2016-12-08 |
| ESTETICA Dental Treatment Unit and Accessories (K161488) | Kaltenbach & Voigt GmbH | 2016-12-08 |
| ImagingRing System (K161400) | Medphoton GmbH | 2016-12-08 |
| Worker Guidewire (K160785) | Argon Medical Devices, Inc. | 2016-12-08 |
| GC70 (K163115) | Samsung Electronics Co., Ltd. | 2016-12-07 |
| OIC Cervical PEEK Spacer (K160222) | The Orthopaedic Implant Company | 2016-12-07 |