| PK AIM (K161825) | Gyrus Acmi, Inc. | 2016-09-26 |
| PORTAGE System (K161878) | Baylis Medical Company, Inc. | 2016-09-26 |
| STERRAD 100NX Sterilizer with ALLClearTM Technology (K160903) | Advanced Sterilization Products | 2016-09-26 |
| Endophys Blood Pressure Monitor (K160945) | Endophys Holdings, LLC | 2016-09-26 |
| FixxSure® X-Link (K162143) | Innovasis, Inc. | 2016-09-23 |
| VSP Cranial System (K151285) | 3D Systems, Inc. | 2016-09-23 |
| Photonica Professional (K160880) | Ward Photonics, LLC | 2016-09-23 |
| PASS XS Spinal System (K160640) | Medicrea International SA | 2016-09-23 |
| BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube (K160657) | Becton, Dickinson and Company | 2016-09-23 |
| EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) (K161945) | Encore Medical L.P. | 2016-09-23 |
| O2VENT T (K161832) | Oventus Manufacturing Pty, Ltd. | 2016-09-23 |
| PowerGlide Pro Midline Catheter (K162377) | C.R. Bard, Inc. | 2016-09-22 |
| Ahead 300 (K161068) | Brainscope Company, Inc. | 2016-09-22 |
| DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) (K161368) | Agfa Healthcare N.V. | 2016-09-22 |
| Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems (K161992) | Integra LifeSciences Corporation | 2016-09-22 |
| ArtPix Mobile EZ2GO (K162224) | Cmt Medical Technologies, Ltd. | 2016-09-22 |
| Pure Vu (K160015) | Motus GI Medical Technologies , Ltd. | 2016-09-22 |
| DONASORB SILVER WOUND DRESSING (K153565) | Virchow Biotech Pvt, Ltd. | 2016-09-22 |
| Emergency Transtracheal Airway Catheter (K153761) | Cook Incorporated | 2016-09-22 |
| MiniMed Quick-serter (K160860) | Medtronic Minimed | 2016-09-22 |
| BIB Stent Placement Catheter (K161451) | NuMED, Inc. | 2016-09-22 |
| Aerin Medical Stylus (K161994) | Aerin Medical, Inc. | 2016-09-22 |
| TrailBlazer Angled Support Catheter (K162384) | Medtronic Vascular, Inc.(Formerly Ev3 Inc.) | 2016-09-22 |
| Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml) (K162188) | Vr Medical Technology | 2016-09-22 |
| CAAS MRV (K162112) | Pie Medical Imaging BV | 2016-09-21 |
| Surefire Guiding Catheter (K162359) | Surefire Medical, Inc. | 2016-09-21 |
| ARIX Hand System (K161746) | Jeil Medical Corporation | 2016-09-21 |
| UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge (K162345) | Neotract, Inc. | 2016-09-21 |
| CPL Insulin Pen Needle (K151090) | Cpl Co., Ltd. | 2016-09-21 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 (K161843) | Toshibamedical Systems Corporation | 2016-09-21 |
| Full Automatic (NIBP) Blood Pressure Monitor (K162338) | Health & Life Co., Ltd. | 2016-09-21 |
| Sterling 5W Diode Laser (K160413) | CAO Group, Inc. | 2016-09-21 |
| QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (K161591) | Globus Medical, Inc. | 2016-09-21 |
| Spinal fixation system (K161151) | Canwell Medical Co., Ltd. | 2016-09-21 |
| Scenium (K162339) | Siemens Medical Solutions USA, Inc. | 2016-09-21 |
| E-CUBE 11 (K161439) | Alpinion Medical Systems Co., Ltd. | 2016-09-21 |
| ATLANTIS ISUS Implant Suprastructures (K160207) | Dentsply International, Inc. | 2016-09-21 |
| da Vinci Xi 12 – 8 mm Reducer (K162411) | Intuitive Surgical, Inc. | 2016-09-21 |
| Solitaire Platinum Revascularization Device (K161879) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-09-21 |
| Affinity NT Oxygenator with Cortiva BioActive Surface (K162016) | Medtronic, Inc. | 2016-09-21 |
| Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) (K160816) | Nexmed Technology Co., Ltd. | 2016-09-21 |
| Cascadia Interbody System (K162264) | K2m, Inc. | 2016-09-21 |
| F&P Eson 2 Nasal Mask (K153505) | Fisher & Paykel Healthcare Limited | 2016-09-20 |
| Hansen Medical Magellan Robotic Catheter 9Fr (K160919) | Hansen Medical, Inc. | 2016-09-20 |
| PINPOINT Endoscopic Fluorescence Imaging System (K161792) | Novadaq Technologies, Inc. | 2016-09-20 |
| Personal Kinetigraph (PKG) System (K161717) | Gkc Manufacturing Pty, Ltd. | 2016-09-20 |
| Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) (K161086) | Sterilmed, Inc. | 2016-09-20 |
| Catalys Precision Laser System (K161455) | Optimedica Corporation | 2016-09-20 |
| SomnoDent ALPHA (K162306) | Somnomed, Inc. | 2016-09-20 |
| Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set (K161721) | Diazyme Laboratories | 2016-09-20 |
| Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip (K161887) | Volcano Corporation | 2016-09-20 |
| GentleCath Glide Intermittent Catheter (K161344) | Convatec Limited | 2016-09-20 |
| AirStrip RPM (K160862) | Airstrip Technologies, Inc. | 2016-09-19 |
| PixelShine (K161625) | Algomedica | 2016-09-19 |
| 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR (K162497) | Eizo Corporation | 2016-09-19 |
| Super Distal Access (SDA) (K161262) | Inneuroco, Inc. | 2016-09-19 |
| Guidewire 0.6 Single Use (K161940) | Fiagon GmbH | 2016-09-18 |
| KARL STORZ Flexible Video-Neuro-Endoscope System (K161112) | KARL STORZ Endoscopy-America, Inc. | 2016-09-17 |
| LigaSure Retractable L-Hook Laparoscopic Sealer/Divider (K161804) | Covidien | 2016-09-16 |
| VORTRAN Manometer (K153733) | Vortran Medical Technology 1, Inc. | 2016-09-16 |
| JiveX (K162008) | Visus Technology Transfer GmbH | 2016-09-16 |
| CATSmart (K160735) | Fresenius Kabi AG | 2016-09-16 |
| NutraStim Hair Laser Helmet (K160728) | Nutra Luxe MD, LLC | 2016-09-16 |
| Sentry WEB SmartInterp (K153654) | Carefusion Germany 234 GmbH | 2016-09-16 |
| Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (K161162) | Ellipse A/S | 2016-09-16 |
| Syntorr K-wire and Pin System (K161489) | Syntorr, Inc. | 2016-09-16 |
| Acclarent Aera Eustachian Tube Balloon Dilation System (DEN150056) | Acclarent, Inc. | 2016-09-16 |
| mi-eye 2, mi-eye 2 monitor (K162475) | Trice Medical | 2016-09-16 |
| Bone Solutions Mixing and Delivery System (K161568) | Bone Solutions, Inc. | 2016-09-16 |
| n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, (K160262) | Institut Straumann AG | 2016-09-16 |
| Neodent Implant System - Titanium Base for CEREC (K160964) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2016-09-16 |
| DoseCHECK (K161946) | Sun Nuclear Corporation | 2016-09-16 |
| TRILLIUM Oval Head Coil 32 (K162079) | Hitachi Medical Systems America, Inc. | 2016-09-16 |
| TEMPEDY (K152946) | Seiratherm GmbH | 2016-09-15 |
| Luminesse Shaded Zirconia SZ (K152023) | Talladium, Inc. | 2016-09-15 |
| PhotonBlade (K162053) | Invuity, Inc. | 2016-09-15 |
| KBL Sunlamp Products (= Device Bundling name) (K151962) | Kbl AG | 2016-09-15 |
| Dentium Implantium & SuperLine Prosthetics (K160828) | Dentium Co., Ltd. | 2016-09-15 |
| CORGRIP NG/NI Tube Retention System (K162110) | Corpak Medsystems, Inc. A Division of Haylard Health | 2016-09-15 |
| Compound W Wart Removal System Dual Power (K161294) | Medtech Products, Inc. | 2016-09-15 |
| Pledgeted COR-SUTURE QUICK LOAD (K160529) | Lsi Soultions | 2016-09-15 |
| Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” (K161067) | Engineered Tissue Solutions, LLC | 2016-09-15 |
| Provicol QM Plus (K161630) | Voco GmbH | 2016-09-15 |
| PROW FUSION-L (K153665) | Nlt Spine, Ltd. | 2016-09-15 |
| CARESCAPE Central Station V2 (K162012) | GE Healthcare | 2016-09-15 |
| Eusol-C (K162013) | Al.Chi.Mi.A. S.R.L | 2016-09-15 |
| LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated (K162047) | Covidien | 2016-09-15 |
| HBOTC Muscle and Nerve Stimulator (K160255) | Hb Medical, Inc. | 2016-09-15 |
| EBit Series Diagnostic Ultrasound System (K162172) | Chison Medical Imaging Co., Ltd. | 2016-09-14 |
| Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable (K161384) | Shockwave Medical, Inc. | 2016-09-14 |
| CAM Titanium Blanks (K160784) | Altatec GmbH | 2016-09-14 |
| TSolution One Cup1 Surgical System (K162195) | THINK Surgical, Inc. | 2016-09-14 |
| dS FootAnkle I6CH 1.5T Coil (K162177) | Invivo Corporation | 2016-09-14 |
| CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System (K162329) | Philips Health Care | 2016-09-14 |
| OSTEON III (K153676) | Genoss Co., Ltd. | 2016-09-14 |
| GEM Premier 3000 (K161818) | Instrumentation Laboratory CO | 2016-09-14 |
| SeaSpine Shoreline ACS - Anterior Cervical Standalone System (K161081) | SeaSpine Orthopedics Corporation | 2016-09-14 |
| Colposcope System (K160341) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2016-09-14 |
| Flexitouch System (K153311) | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016-09-14 |
| StealthStation System with Cranial Software (K153660) | Medtronic Navigation, Inc. | 2016-09-14 |