| K172144 — CoolSculpting System | Zeltiq Aesthetics Nov 1, 2017 |
| K172347 — GMK Hinge, GMK Revision | Medacta International S.A. Nov 1, 2017 |
| K172649 — Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor | Heidelberg Engineering GmbH Nov 1, 2017 |
| K173175 — Paramount Anterior Cervical Cage System | Spine Wave, Inc. Nov 1, 2017 |
| K171580 — Monitor B125, Monitor B105 | Ge Medical Systems (China) Co., Ltd. Nov 1, 2017 |
| K171026 — Mytens Model: BW-TSX | Bewell Connect Corp. Nov 1, 2017 |
| K170437 — Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. Nov 1, 2017 |
| K170439 — AN87 Dosimeter | Andersen Sterilizers, Inc. Nov 1, 2017 |
| K162812 — Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set | Unomedical A/S Nov 1, 2017 |
| K170513 — MAUSER PG II Sharps Container | Mauzer USA, LLC Nov 1, 2017 |
| K170353 — ABX MICROS ES 60 OT and ABX MICROS ES 60 CT | HORIBA ABX SAS Nov 1, 2017 |
| K172268 — iFuse Implant System- iFuse Navigation | SI-BONE, Inc. Oct 31, 2017 |
| K172572 — Stryker Upper-Face AXS screws and Mid-Face AXS screws | Stryker Oct 31, 2017 |
| K173318 — Rapid HB, Rapid LB, Rapid MB | 3M Deutschland GmbH Oct 31, 2017 |
| K171767 — Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. Oct 31, 2017 |
| K172333 — Sysmex CS-5100 | Siemens Healthcare Diagnostics Products GmbH Oct 31, 2017 |
| K171708 — ALOKA ARIETTA 850 | Hitachi Healthcare Americas Corporation Oct 31, 2017 |
| K172447 — JO Gelato Flavored Personal Lubricants | United Consortium Oct 31, 2017 |
| K170359 — Trinity Dual Mobility System | Corin U.S.A. Limited Oct 31, 2017 |
| K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. Oct 31, 2017 |
| K173080 — IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) | Huvexel Co. , Ltd. Oct 31, 2017 |
| K170427 — Anprolene SteriTest | Andersen Sterilizers, Inc. Oct 31, 2017 |
| K171643 — Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed | Geistlich Pharma AG Oct 30, 2017 |
| K171525 — Intellijoint HIP Generation 2B System | Intellijoint Surgical, Inc. Oct 30, 2017 |
| K170917 — Bi-Ostetic Bioactive Glass Foam | Berkeley Advanced Biomaterials Oct 30, 2017 |
| K172351 — AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert | Encore Medical L.P. Oct 30, 2017 |
| K170426 — AN85/AN86 EO Indicators | Andersen Sterilizers, Inc. Oct 30, 2017 |
| K172236 — Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled | Avinger, Inc. Oct 30, 2017 |
| K172402 — ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | Luminex Corporation Oct 30, 2017 |
| K172326 — Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics Oct 30, 2017 |
| K172404 — SenoBright HD | GE Healthcare Oct 30, 2017 |
| K172943 — Flex-Thread Fibula Pin System | Intrafuse, LLC Oct 30, 2017 |
| K171008 — Anorganic Bone Mineral with Collagen in Delivery Applicator | Collagen Matrix, Inc. Oct 30, 2017 |
| K163659 — Crystal Vision | I.C Medical, Inc. Oct 30, 2017 |
| K172646 — XIDF-AWS801, Angio Workstation, V7.0 | Toshibamedical Systems Corporation Oct 30, 2017 |
| K172296 — Stethee Pro | M3Dicine Pty , Ltd. Oct 30, 2017 |
| K170585 — Skylife | Neolight, LLC Oct 27, 2017 |
| K173122 — Abbott Architect Free T4 | Abbott Laboratories Oct 27, 2017 |
| K172038 — Trocar | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd Oct 27, 2017 |
| K173132 — ASPIRE Cristalle | Fujifilm Medical Systems U.S.A, Inc. Oct 27, 2017 |
| K172077 — Cutera enlighten III Laser System | Cutera, Inc. Oct 27, 2017 |
| K162738 — Puritan Bennett 980 Ventilator System | Covidien Oct 27, 2017 |
| K170429 — Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. Oct 27, 2017 |
| K171979 — Tubing Pack | Medtronic, Inc. Oct 27, 2017 |
| K172815 — 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) | Shenzhen Beacon Display Technology Co., Ltd. Oct 27, 2017 |
| K170466 — Automatic Blood Pressure Monitor Model LD-518 & LD-537 | Honsun (Nantong) Co., Ltd. Oct 27, 2017 |
| K170345 — SOFTDISO | Best Nomos Oct 27, 2017 |
| K171926 — C5 Diagnostic Ultrasound System | Guangzhou Sonostar Technologies Co., Ltd. Oct 27, 2017 |
| K173104 — Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly | Total Joint Orthopedics, Inc. Oct 27, 2017 |
| K173184 — Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific Oct 27, 2017 |