| K171590 — Distal Elbow Plating System | Skeletal Dynamics, LLC Jun 27, 2017 |
| K163432 — Stellar LEAP | Pdg Product Design Group, Inc. Jun 27, 2017 |
| K171163 — Contact Lens Case Round Glasses | Fiftytwoways, Ltd. Jun 27, 2017 |
| K170297 — Tranquil Interbody System | Nexus Spine, LLC Jun 27, 2017 |
| K163216 — Pinpoint GT Needles | C.R. Bard, Inc. Jun 27, 2017 |
| K162874 — Cannulated Screws Neoortho | Neoortho Produtos Ortopedicos S/A Jun 27, 2017 |
| K171536 — RayStation | RaySearch Laboratories AB (PUBL) Jun 27, 2017 |
| K171794 — Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. Jun 27, 2017 |
| K170735 — Powder-Free Clear Vinyl Patient Examination Gloves | Zibo Yue Fan Medical Products Co, Ltd. Jun 27, 2017 |
| K170817 — Halcyon | Varian Medical Systems, Inc. Jun 27, 2017 |
| K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | Lin-Zhi International, Inc. Jun 26, 2017 |
| K170902 — Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit | Spr Therapeutics, LLC Jun 26, 2017 |
| K170962 — NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated Jun 26, 2017 |
| K162797 — SpringTMS | Eneura, Inc. Jun 26, 2017 |
| K170444 — PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. Jun 26, 2017 |
| K170568 — CardioLogs ECG Analysis Platform | Cardiologs Technologies Jun 26, 2017 |
| K170045 — Swedge Pedicle Screw Fixation System | Spinal Resources, Inc. Jun 26, 2017 |
| K163449 — HyPHo Laser System | Hyper Photonics Srl Jun 23, 2017 |
| K171009 — LASEMD Laser System | Lutronic Corporation Jun 23, 2017 |
| K171188 — Ossler Exam Scope | Lr Med, Inc. Jun 23, 2017 |
| K163437 — hypodermic Pinpoint GT Needle | C.R. Bard, Inc. Jun 23, 2017 |
| K162993 — Gemini Sterilization Wrap | Medline Industries, Inc. Jun 23, 2017 |
| K171324 — Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics | Surgical Instrument Service And Savings, Inc. Jun 23, 2017 |
| K170270 — Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline | Ls Scientific Inc. D.B.A. Kse Scientific Jun 23, 2017 |
| K171146 — Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. | Arrow International, Inc. (Subsidiary Of Telelflex Inc.) Jun 23, 2017 |
| K170094 — POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED | Vietglove Corporation Jun 23, 2017 |
| K162821 — Babyleo TN500 | Draegerwerk AG & CO Kgaa Jun 23, 2017 |
| K162897 — Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser | Beckman Coulter Jun 23, 2017 |
| K153138 — Cerdak Basic | Bu Polysciences Equipment & Trading, LLC Jun 23, 2017 |
| K162582 — HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit | Fisher & Paykel Healthcare Jun 23, 2017 |
| K170302 — YELLOW LASER PHOTOCOAGULATOR YLC-500 | Nidek Co., Ltd. Jun 23, 2017 |
| K163668 — SUITESTENSA | Ebit Srl Jun 23, 2017 |
| K170620 — ReBOSSIS85 | Orthorebirth Co., Ltd. Jun 23, 2017 |
| K162678 — Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl | Roche Diagnostics Jun 23, 2017 |
| K170759 — CRE Pulmonary Balloon Dilatation Catheter | Boston Scientific Corporation Jun 23, 2017 |
| K171307 — EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. Jun 22, 2017 |
| K171606 — AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. (Aos) Jun 22, 2017 |
| K170933 — Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. Jun 22, 2017 |
| K163412 — Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) | Girgis Scope, LLC Jun 22, 2017 |
| K162299 — Spiral Shape Dental Implant System | Gp Implants Jun 22, 2017 |
| K163399 — Tria Firm Ureteral Stent | Boston Scientific Corporation Jun 22, 2017 |
| K170629 — VITRUVIAN INFILTRATION PUMP | Black & Black Surgical, Inc. Jun 22, 2017 |
| K170883 — FilmArray NGDS Warrior Panel | Biofire Defense, LLC Jun 22, 2017 |
| K171047 — Sterile Polyisoprene Powder Free Surgical Gloves | Better Care Plastic Technology Co., Ltd. Jun 22, 2017 |
| K160899 — CoVa Monitoring System 2 | Tosense, Inc. Jun 22, 2017 |
| K163316 — Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | Carefusion 303, Inc. Jun 22, 2017 |
| K170299 — Ion PGM Dx System | Life Technologies Corporation Jun 22, 2017 |
| K170922 — Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) | Innovative Health, LLC Jun 22, 2017 |
| K171591 — CUBEScan BioCon-900 (Bladder Volume Measurement System) | Mcube Technology Co., Ltd. Jun 22, 2017 |
| K170727 — VariAx 2 Compression Plating System | Stryker GmbH Jun 22, 2017 |