| K162864 — OsteoVation Impact | Skeletal Kinetics, LLC Jan 13, 2017 |
| K163519 — RX DC | Cefla S.C. Jan 13, 2017 |
| K161106 — PANPAC DISPOSABLE VACUUM CURETTES | Panpac Medical Corporation Jan 13, 2017 |
| K163533 — EzDent-i; E2; ProraView | Ewoosoft Co., Ltd. Jan 12, 2017 |
| K162336 — Contour Next EZ Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. Jan 12, 2017 |
| K161902 — Meridian M110 Fetal Monitoring System | Mindchild Medical Jan 12, 2017 |
| K163635 — ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. Ultrasound Group Jan 12, 2017 |
| K162532 — WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. Jan 12, 2017 |
| K162323 — Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. Jan 12, 2017 |
| K161217 — VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) | bioMerieux, Inc. Jan 12, 2017 |
| K163176 — Exilis XP II | BTL Industries, Inc. Jan 12, 2017 |
| K162500 — Ostial Sprit Cannulae | Spyder Medical Jan 12, 2017 |
| K162884 — SpineGuard DSG Zavation Screw System | Spineguard S.A. Jan 12, 2017 |
| K162694 — Ayers Rock Cervical interbody fusion system | Spineway Jan 12, 2017 |
| K163544 — Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. Jan 12, 2017 |
| K162173 — Elecsys CYFRA 21-1 CalCheck 5 | Roche Diagnostics Jan 12, 2017 |
| K163205 — 48CH Head Coil | Ge Healthcare Coils (Usa Instruments, Inc.) Jan 12, 2017 |
| K163521 — Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. Jan 12, 2017 |
| K162754 — FREND Vitamin D Test System | Nanoentek USA, Inc. Jan 12, 2017 |
| K162387 — U-IGNITE Bladeless Trocar | Tianjin Uwell Medical Device Manufacturing Co., Ltd. Jan 11, 2017 |
| K163128 — Epic Pro | Biolase, Inc. Jan 11, 2017 |
| K161281 — Dentalis Bio Solution Implants | Dentalis Bio Solution Implants, LLC Jan 11, 2017 |
| K162201 — Desara TV, Desara Blue TV | Caldera Medical, Inc. Jan 11, 2017 |
| K162261 — CERAMAGE UP | Shofu Dental Corporation Jan 11, 2017 |
| K162885 — SPY Phi Open Field Handheld Fluorescence Imaging System | Novadaq Technologies, Inc. Jan 11, 2017 |
| K161517 — Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. Jan 11, 2017 |
| K161204 — ENDOCAM Flex HD Camera System 5521 | Richard Wolf Medical Instruments Corporation Jan 11, 2017 |
| K160178 — Lympha-Flow(LF1200) | Daesung Maref Co., Ltd. Jan 11, 2017 |
| K162765 — Venus Velocity Diode Laser System | Venus Concept , Ltd. Jan 11, 2017 |
| K162057 — ConceptoMed Luer-Jack Slip 10ml | Conceptomed AS Jan 11, 2017 |
| K163479 — R2P Metacross RX | KANEKA Corporation Jan 11, 2017 |
| K162810 — InSeca ARC Stylus, Aerin Console | Aerin Medical, Inc. Jan 11, 2017 |
| K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | Bio-Rad Laboratories Jan 10, 2017 |
| K163252 — Mammomat Fusion with Stereotactic Biopsy | Siemens Medical Solutions USA, Inc. Jan 10, 2017 |
| K163120 — EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System | Philips Ultrasound, Inc. Jan 10, 2017 |
| K162179 — osteo-WEDGE II ® Open Wedge Bone Locking Plate System | Graham Medical Technologies, LLC Dba Gramedica Jan 10, 2017 |
| K160991 — Neo GBR System | Neobiotech Co., Ltd. Jan 10, 2017 |
| K162805 — Akros Fibulink Syndesmosis Repair Kit | Akros Medical Jan 10, 2017 |
| K162767 — Sentinel BreastScan II System | First Sense Medical, LLC Jan 9, 2017 |
| K162819 — Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs | Hartalega Sdn Bhd Jan 9, 2017 |
| K162818 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | Hartalega Sdn Bhd Jan 9, 2017 |
| K161841 — D2P | 3D Systems, Inc. Jan 9, 2017 |
| K151857 — Love Alchemy's Love Lotion | Love Alchemy, LLC Jan 9, 2017 |
| K162083 — RII Multi-function Infrared Thermometer, Model TH52Z | Radiant Innovation, Inc. Jan 9, 2017 |
| K162483 — Symbia Intevo Bold | Siemens Medical Solutions USA, Inc. Jan 9, 2017 |
| K161508 — Ceruloplasmin | Beckman Coulter Ireland, Inc. Jan 9, 2017 |
| K161971 — Bindex BI-2 | Bone Index Finland , Ltd. Jan 9, 2017 |
| K162208 — DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. Jan 9, 2017 |
| K163142 — SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader | ArthroCare Corporation Jan 6, 2017 |
| K163141 — NAMIC ClearaCIL Contrast Injection Lines | AngioDynamics, Inc. Jan 6, 2017 |