| K191575 — ARx Spinal System | Life Spine, Inc. Aug 8, 2019 |
| K191257 — Erchonia EVRL | Erchonia Corporation Aug 8, 2019 |
| K181760 — Transit-Pellets | Medifactia AB Aug 8, 2019 |
| K183312 — Conformity Stem | United Orthopedic Corporation Aug 8, 2019 |
| K191352 — binx health io CT/NG Assay | Binx Health, Inc. Aug 8, 2019 |
| K190674 — REFRESH RELIEVA For CONTACTS | Allergan, Inc. Aug 8, 2019 |
| K190562 — iTotal Identity Cruciate Retaining Knee Replacement System | Conformis, Inc. Aug 8, 2019 |
| K190716 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead | Medtronic Aug 8, 2019 |
| K190385 — CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System | In2Bones USA, LLC Aug 8, 2019 |
| K191274 — BonAlive Granules | Bonalive Biomaterials, Ltd. Aug 7, 2019 |
| K183276 — 7D Surgical System | 7D Surgical, Inc. Aug 7, 2019 |
| K190650 — Revolution Centrifugal Blood Pump | Sorin Group Italia S.R.L. Aug 7, 2019 |
| K190893 — Non-invasive Hemodynamic Blood Pressure Monitor | Vita-Course Technologies Co., Ltd. Aug 7, 2019 |
| K191840 — Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | Shockwave Medical, Inc. Aug 7, 2019 |
| K191394 — ILLUMISITE Platform | Covidien, LLC Aug 7, 2019 |
| K191606 — RenovoCath | Renovorx, Inc. Aug 7, 2019 |
| K191012 — Navigated Pedicle Access Kit | Izi Medical Products, LLC Aug 7, 2019 |
| K191871 — 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set | Boston Scientific Corporation Aug 7, 2019 |
| K191841 — Accurate Multi Panel Drug Urine Test Cup | Healstone Biotech, Inc. Aug 7, 2019 |
| K190885 — Elevation Spine Saber-C System | Elevation Spine Aug 7, 2019 |
| K190992 — OrthoPediatrics PediFoot Deformity Corrections System | OrthoPediatrics Corp. Aug 6, 2019 |
| K191423 — Normandy VBR System | Zavation Medical Products, LLC Aug 6, 2019 |
| K191295 — Percutaneous Introducer Needle | Progressive Medical, Inc. Aug 6, 2019 |
| K191835 — CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments | Globus Medical, Inc. Aug 6, 2019 |
| K183458 — exoplan 2.3 | Exocad GmbH Aug 6, 2019 |
| K183387 — M3290B Patient Information Center iX | Philips Medical Systems Aug 6, 2019 |
| K190502 — ENFit Oral / Enteral Syringe | Jiangsu Caina Medical Co.,Ltd Aug 6, 2019 |
| K191158 — The AIO Solution | Orfit Industries NV Aug 6, 2019 |
| K191781 — Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System | Zimmer GmbH Aug 6, 2019 |
| K191565 — Endoskeleton TCS Interbody Fusion Device | Titan Spine, Inc. Aug 6, 2019 |
| K183120 — EmboCube Embolization Gelatin | Biosphere Medical, S.A. Aug 6, 2019 |
| K190535 — BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG Aug 6, 2019 |
| K191496 — TDS Standard Solution | Mesa Laboratories, Inc. Aug 5, 2019 |
| K190399 — Beddr 200 System | Hancock Medical, Inc. Aug 5, 2019 |
| K191877 — FLUOROspeed | Shimadzu Corporation Aug 5, 2019 |
| K191225 — EEG Electrode Template | Rhythmlink International, LLC Aug 5, 2019 |
| K183323 — UPJ Occlusion Balloon Catheter | Cook Incorporated Aug 5, 2019 |
| K191262 — aBSI | Exini Diagnostics AB Aug 5, 2019 |
| K191033 — LunaGuard Nighttime Dental Protector | Mckeon Products Aug 5, 2019 |
| K191222 — Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV | Prismatik Dentalcraft, Inc. Aug 5, 2019 |
| K191766 — VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) | bioMerieux, Inc. Aug 5, 2019 |
| K183305 — Crossing Support Catheter | Tractus Vascular, LLC Aug 5, 2019 |
| K181154 — Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor | Shenzhen Med-Link Electronics Tech Co., Ltd. Aug 2, 2019 |
| K191546 — Epicardial Access System | Baylis Medical Company, Inc. Aug 2, 2019 |
| K191741 — Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape | Intertape Polymer, Inc. Aug 2, 2019 |
| K191321 — Primelase Excellence | High Technology Products S.L.U Aug 2, 2019 |
| K191813 — MobileDiagnost wDR 2.2 | Sedecal., Sa. Aug 2, 2019 |
| K191602 — APA Oxy Blade | Venner Medical (Singapore) Pte, Ltd. Aug 2, 2019 |
| K190338 — 046 Zenith Flex | Inneuroco, Inc. Aug 2, 2019 |
| K183112 — DiLumen Endolumenal Interventional Knife (DiLumen IK) | Lumendi, LLC Aug 2, 2019 |