| K182532 — Liba3 System | National Cardiac, Inc. May 15, 2019 |
| K190639 — Endosee System | CooperSurgical, Inc. May 15, 2019 |
| K183292 — Topaz Mobile DR System | DRGEM Corporation May 15, 2019 |
| K182520 — Flexible Overtube | Sumitomo Bakelite Co., Ltd. May 15, 2019 |
| K182408 — Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 | Olympus Medical Systems Corp. May 15, 2019 |
| K190297 — Celerity HP Incubator | STERIS Corporation May 14, 2019 |
| K190974 — D'Vill Introducer | NuMED, Inc. May 14, 2019 |
| K181419 — FLIX-EMS | Casgarum Investment, S.L. May 14, 2019 |
| K190069 — SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Arrowhead De, LLC May 14, 2019 |
| K190985 — BAROnova Insufflation System, BAROnova Accessory Kit | Baronova, Inc. May 14, 2019 |
| K190670 — ORTHOLOC 2 Lapidus with Rotation System | Wrightmedicaltechnologyinc May 14, 2019 |
| K190315 — ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat | Phadia AB May 14, 2019 |
| K190848 — JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. May 14, 2019 |
| K190764 — SurgicalAR | Medivis, Inc. May 13, 2019 |
| K190170 — MVP Cervical Plate System | GS Medical Co., Ltd. May 13, 2019 |
| K190604 — PIVO | Velano Vascular May 13, 2019 |
| K190219 — Simplexa VZV Direct, Simplexa VZV Positive Control Pack | Diasorin Molecular, LLC May 13, 2019 |
| K183109 — ControlRad Trace Model 8 | Controlrad, Inc. May 13, 2019 |
| K183515 — MR8 Drill System, Midas Rex MR8 ClearView Tools | Medtronic Powered Surgical Solutions May 12, 2019 |
| K182180 — SPEAC System | Brain Sentinel, Inc. May 11, 2019 |
| K190989 — 6400 Ultrasound System (MyLabX6, MyLabX7) | Esaote, S.P.A. May 10, 2019 |
| K183583 — Vanguard Complete Knee System | Zimmer, Inc. May 10, 2019 |
| K190027 — SteriStay | Toul Meditech AB May 10, 2019 |
| K190854 — Therm-X | Zenith Technical Innovations May 10, 2019 |
| K190173 — Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound | Jk-Holding GmbH May 10, 2019 |
| K190995 — ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. May 10, 2019 |
| K191046 — L10 LED Light Source with AIM, L11 LED Light Source with AIM | Stryker May 10, 2019 |
| K181545 — Hysteroscope System | Shanghai AnQing Medical Instrument Co., Ltd. May 10, 2019 |
| K182612 — Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) | Zibo Yahao Supplies Co., Ltd. May 10, 2019 |
| K183319 — Triangle System | AliveCor, Inc. May 10, 2019 |
| K182959 — Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. May 10, 2019 |
| K190275 — GenePOC Carba | Genepoc, Inc. May 10, 2019 |
| K183160 — TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | Haemonetics Corporation May 9, 2019 |
| K181933 — DePuy Synthes Sterilization Container System | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. May 9, 2019 |
| K182617 — ATEC IOM Accessory Instruments | Alphatec Spine, Inc. May 9, 2019 |
| K190917 — V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems | STERIS Corporation May 9, 2019 |
| K181894 — TOF-Cuff monitor | Rgb Medical Devices SA May 9, 2019 |
| K190666 — CYGNUS Anterior Cervical Plate System | MiRus, LLC May 9, 2019 |
| K181491 — Delta Dual Mobility System | Lima Corporate S.P.A. May 9, 2019 |
| K190393 — Wingman 14C Crossing Catheter | Reflow Medical, Inc. May 9, 2019 |
| K183310 — Encore System | Siesta Medical, Inc. May 9, 2019 |
| K190699 — Rowheels Revolution 1.0 | Rowheels, Inc. May 9, 2019 |
| K190948 — Magic Clear Aligners | Voodoo Manufacturing, Inc. May 9, 2019 |
| K190218 — Unscented Menstrual Tampon | Qingdao Youjia Hygiene Technology Co., Ltd. May 9, 2019 |
| K190567 — KeYi Spinal Fixation System | Beijing Keyi Medical Device Technology Co., Ltd. May 8, 2019 |
| K182428 — GlucoLeader Enhance Blood Glucose Monitoring System | Hmd Biomedical, Inc. May 8, 2019 |
| K183126 — Electrosurgical accessory | New Deantronics Taiwan , Ltd. May 8, 2019 |
| K190092 — UNiD Patient specific 3D printed TLIF cage | Medicrea International SA May 8, 2019 |
| K190223 — Cepheid Xpert CT/NG Control Panel | Microbiologics, Inc. May 8, 2019 |
| K182238 — Reprocessed ViewFlex Xtra ICE Catheter | Stryker Sustainability Solutions May 8, 2019 |