| K181504 — Stryker Pediatric Mandibular Distractor 2 | Stryker Sep 11, 2018 |
| K182196 — Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth | Imediplus, Inc. Sep 11, 2018 |
| K181211 — Human Tecar HCR 1002 | Unibell S.R.L Sep 10, 2018 |
| K181078 — The Sex Gel | Necessaire, Inc. Sep 10, 2018 |
| K181455 — ProSun sunlamp products, Luxura sunlamp products | Prosun International, LLC Sep 10, 2018 |
| K173941 — IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH Sep 10, 2018 |
| K182055 — SECULOK ACP System | U&I Corporation Sep 10, 2018 |
| K181415 — XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 | Canon Medical Systems Corporation Sep 10, 2018 |
| K182230 — Multi Modality Viewer | Vital Images, Inc. Sep 7, 2018 |
| K173883 — External Fixation System | Life Spine, Inc. Sep 7, 2018 |
| K181061 — Corin Optimized Positioning System (OPS) Femoral | Corin USA Sep 7, 2018 |
| K170702 — mediCAD 4.0 | Medicad Hectec GmbH Sep 7, 2018 |
| K181311 — Philips Hemodynamic Application R1.0 | Philips Medical Systems Nederlands B.V. Sep 7, 2018 |
| K181525 — INNOVANCE Free PS Ag | Siemens Healthcare Diagnostics Products GmbH Sep 7, 2018 |
| K181270 — Disposable SpO2 Sensors, Reusable SpO2 Sensors | Orantech, Inc. Sep 7, 2018 |
| K182053 — Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. Sep 7, 2018 |
| K181423 — AMSure Sterile Water, and Sterile Normal Saline for Wound Flush | Amsino International, Inc. Sep 7, 2018 |
| K182079 — Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask | Medtec Inc. Dba Civco Medical Solutions Sep 7, 2018 |
| K180778 — Exceed Microneedling Device | Mt. Derm GmbH Sep 7, 2018 |
| K182147 — CTXX85 | Analogic Corporation Sep 7, 2018 |
| K182144 — Bi-Flex Evo | Promepla Sam Sep 7, 2018 |
| K181537 — GLOW800 | Leica Microsystems (Schweiz) AG Sep 7, 2018 |
| K182208 — syngo.via View&GO (Version VA10A) | Siemens Healthcare GmbH Sep 7, 2018 |
| K182148 — SILVERBACK Gorilla Plating System | Paragon 28, Inc. Sep 7, 2018 |
| K182263 — RetCam 3 ; RetCam Shuttle ; RetCam Portable | Natus Medical Incorporated Sep 7, 2018 |
| K181811 — ReTrace Ureteral Access Sheath | Coloplast A/S Sep 7, 2018 |
| K181688 — R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co. , Ltd. Sep 7, 2018 |
| K173813 — IPL Hair Removal Device Joy Version | Shen Zhen Cosbeauty Co., Ltd. Sep 7, 2018 |
| K181518 — Sebacia Microparticles | Sebacia, Inc. Sep 6, 2018 |
| K173893 — Trabis | Coligne AG Sep 6, 2018 |
| K182153 — Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. Sep 6, 2018 |
| K181558 — Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens | Gelflex Laboratories Sep 6, 2018 |
| K180728 — Spinal Elements Cerclage System | Spinal Elements, Inc. Sep 6, 2018 |
| K180465 — Provata Implant System | Southern Implants (Pty), Ltd. Sep 6, 2018 |
| K172834 — Dual output digital therapy massager | Shenzhen Osto Technology Co., Ltd. Sep 6, 2018 |
| K181128 — Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) | Contego Medical, LLC Sep 6, 2018 |
| K182234 — Optima XR240amx | Ge Medical Systems, LLC Sep 6, 2018 |
| K181662 — Iridex TruFocus LIO Premiere | Iridex Corporation Sep 5, 2018 |
| K182138 — Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD | Eleckta Limited Sep 5, 2018 |
| K173976 — Masimo Acoustic Respiration Sensors, infant and neonate | Masimo Corporation Sep 5, 2018 |
| K181878 — Kiierr 272 Laser, Kiierr 148 Laser | Kiierr International, LLC Sep 5, 2018 |
| K173921 — HD-500 Video Endoscope System | Sonoscape Medical Corp. Sep 5, 2018 |
| K173665 — AMSafe Sure-Lok Needle-Free Connector | Amsino International, Inc. Sep 5, 2018 |
| K181532 — Exactech Alteon Monobloc Revision Stem | Exactech, Inc. Sep 4, 2018 |
| K173568 — NeoBase 2 Non-derivatized MSMS Kit | Wallac Oy, Subsidiary Of Perkinelmer, Inc. Sep 4, 2018 |
| K181314 — IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension | Philips Medizin Systeme Boeblingen GmbH Sep 4, 2018 |
| K181814 — AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | Amsino International, Inc. Sep 4, 2018 |
| K181249 — EUSRA RF Electrode | Starmed Co., Ltd. Sep 4, 2018 |
| K181510 — ECHOLASER X4 | El.En Electronic Engineering Spa Sep 4, 2018 |
| K173765 — Surveyor Patient Monitor | Mortara Instrument, Inc. Sep 4, 2018 |