| K170548 — InSure ONE | Enterix, Inc. Oct 5, 2017 |
| K172093 — Reprocessed Covidien Trocar | Renovo, Inc. Oct 5, 2017 |
| K170344 — Tahoe Uni Knee System | Consensus Orthopedics, Inc. Oct 5, 2017 |
| K172667 — MagVita TMS Therapy w/MagPro R20 | Tonica Elektronik A/S Oct 5, 2017 |
| K171689 — ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | Medtronic Sofamor Danek USA, Inc. Oct 5, 2017 |
| K170452 — Medacta Shoulder System | Medacta International S.A. Oct 5, 2017 |
| K163366 — Shanghai Sanyou CARMEN Cervical Fusion System | Shanghai Sanyou Medical Co, Ltd. Oct 5, 2017 |
| K172558 — iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit | Stryker Corporation Oct 5, 2017 |
| K172059 — LinkQuest Diagnostic Ultrasound System model SQ860 | Linkquest, Inc. Oct 5, 2017 |
| K171503 — Reprocessed CristaCath Diagnostic Electrophysiology Catheter | Innovative Health, LLC Oct 5, 2017 |
| K170264 — Gold AQ Blood Glucose Monitoring System | Changsha Sinocare, Inc. Oct 5, 2017 |
| K171491 — R2P Destination Slender Guiding Sheath | Terumo Medical Corporation Oct 5, 2017 |
| K171175 — Aquarius 8600 1417WC | Imaging Dynamics Company , Ltd. Oct 5, 2017 |
| K172855 — Vitrea Advanced Visualization, Version 7.6 | Vital Images, Inc. Oct 5, 2017 |
| K172089 — PROLENE Soft Polypropylene Mesh | ETHICON, Inc. Oct 5, 2017 |
| K172099 — Shoocin Introducer Kit | Lepu Medical Technology (Beijing) Co., Ltd. Oct 5, 2017 |
| K172574 — SyncVision System | Volcano Corporation Oct 5, 2017 |
| K171991 — EMPOWR Porous Knee System | Encore Medical L.P. Oct 4, 2017 |
| K172289 — pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent | Q Urological Corporation Oct 4, 2017 |
| K172174 — Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. Oct 4, 2017 |
| K172671 — HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal | Conmed Corporation Oct 4, 2017 |
| K172691 — Ultrasonic Generator | Olympus Medical Systems Corp. Oct 4, 2017 |
| K172092 — Reprocessed Shavers/Burs | Renovo, Inc. Oct 4, 2017 |
| K172607 — Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Philips Health Care Oct 4, 2017 |
| K172520 — CRE RX Biliary Balloon Dilatation Catheter | Boston Scientific Corporation Oct 4, 2017 |
| K171182 — ri-former Predictive Thermometer | Rudolf Riester GmbH Oct 4, 2017 |
| K172285 — Ablatherm Fusion | Edap Technomed, Inc. Oct 3, 2017 |
| K172621 — HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) | Hardy Diagnostics Oct 3, 2017 |
| K172684 — Smith & Nephew, Inc. ANTHOLOGY AFIT Hip Stem | Smith & Nephew, Inc. Oct 3, 2017 |
| K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | Codman & Shurtleff, Inc. Oct 3, 2017 |
| K172016 — Force Fiber Fusion Suture | Teleflex Medical Incorporated Oct 3, 2017 |
| K172884 — Arisure Closed Vial Adapter | Yukon Medical Oct 3, 2017 |
| K170506 — ECG Check - Universal, ECG Check - Universal Plus | Cardiac Designs, Inc. Oct 2, 2017 |
| K172210 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker Trauma AG Oct 2, 2017 |
| K172596 — Large Screws Range | Newclip Technics Oct 2, 2017 |
| K171768 — Trident® II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics Oct 2, 2017 |
| K170375 — Nobilplast Denture Resin | Cmp Industries, LLC Oct 2, 2017 |
| K171978 — Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 | Shenzhen Dongdixin Technology Co., Ltd. Oct 2, 2017 |
| K171250 — BRIDALVEIL Occipital Cervical Thoracic System | Astura Medical Oct 2, 2017 |
| K170873 — Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl | Swissmeditec GmbH Oct 2, 2017 |
| K163183 — Yooeehouse Breast Pump | Nantong Poly Technology Co., Ltd. Oct 2, 2017 |
| K170054 — iSurg | Jaco, LLC Dba Macan Manufacturing And Bna Burz North America Oct 2, 2017 |
| K170119 — Calix Lumbar Spinal Implant System | X-Spine Systems, Inc. Sep 29, 2017 |
| K170166 — CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture | Cpt Sutures Co., Ltd. Sep 29, 2017 |
| K171792 — Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Alere Scarborough, Inc. Sep 29, 2017 |
| K172420 — Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim | Wear Safe (Malaysia) Sdn. Bhd. Sep 29, 2017 |
| K163326 — SmartEP | Intelligent Hearing Systems Sep 29, 2017 |
| K171408 — Carbon Monoxide Breath Sensor System (COBSS) | Carrot Sense, Inc. Sep 29, 2017 |
| K172080 — Photoelectric Therapy System | Xstrahl, Ltd. Sep 29, 2017 |
| K170505 — SecurePortIV Catheter Securement Adhesive | Adhezion Biomedical, LLC Sep 29, 2017 |