| K190722 — TriMAX Implant System | Crossroads Extemity Systems, LLC Aug 16, 2019 |
| K190853 — Vyntus BODY | Vyaire Medical, Inc. Aug 16, 2019 |
| K192018 — Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device | Titan Spine, Inc. Aug 16, 2019 |
| K191645 — SKR 4000 | Konica Minolta, Inc. Aug 16, 2019 |
| K191933 — COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal | Johnson & Johnson Surgical Vision, Inc. Aug 16, 2019 |
| K183208 — Suprasorb A + Ag R | Speciality Fibres And Materials, Ltd. Aug 15, 2019 |
| K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co KG Aug 15, 2019 |
| K183282 — Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. Aug 15, 2019 |
| K191621 — ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System | Choice Spine, LLC Aug 15, 2019 |
| K190991 — Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) Aug 15, 2019 |
| K191922 — ACUSON P200 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Aug 15, 2019 |
| K183230 — OneDraw A1C Test System | Drawbridge Health, Inc. Aug 15, 2019 |
| K191200 — TULSA-PRO System | Profound Medical, Inc. Aug 15, 2019 |
| K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Sterilmed, Inc. Aug 15, 2019 |
| K190264 — Viola | Meditime Co., Ltd. Aug 15, 2019 |
| K190925 — HeartFlow FFRct Analysis | HeartFlow, Inc. Aug 15, 2019 |
| K190328 — HCT Empty EVA Container Pack | Health Care Technologies Aug 15, 2019 |
| K182618 — SleepImage System | Mycardio, LLC Dba Sleepimage. Aug 14, 2019 |
| K191241 — AutoStrut | Orthospin Aug 14, 2019 |
| K190852 — Zurich Pressure Guidewire System Model 100 | Zurich Medical, Inc. Aug 14, 2019 |
| K191553 — NuVaisve® Reline® Cervical System | Nu Vasive, Incorporated Aug 14, 2019 |
| K190063 — Servator C SALF Solution | S.A.L.F. Spa Aug 14, 2019 |
| K190849 — IS-III active System_S-narrow Type | Neobiotech Co., Ltd. Aug 14, 2019 |
| K190689 — SignalMark Breast Marker | View Point Medical, Inc. Aug 14, 2019 |
| K190261 — BOSS Toe Fixation System | Arthrosurface, Inc. Aug 14, 2019 |
| K191731 — Instylla Microcatheter | Instylla, Inc. Aug 13, 2019 |
| K190428 — Elecsys Anti-HAV II | Roche Diagnostics Aug 13, 2019 |
| K191376 — Modular Power Standing System | Motion Concepts Aug 13, 2019 |
| K191582 — Cartesion Prime | Canon Medical Systems Corporation Aug 13, 2019 |
| K190970 — PROSTEP TBI (Tailors Bunion Implant) System | Wrightmedicaltechnologyinc Aug 13, 2019 |
| K191024 — xPORT Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. Aug 13, 2019 |
| K183316 — Dr J Spinal and Epidural Needles | Dr. Japan Co., Ltd. Aug 12, 2019 |
| K191009 — Arsenal Plating System | Trilliant Surgical Aug 12, 2019 |
| K191494 — Facilis Spinal System | Baui Biotech Co., Ltd. Aug 12, 2019 |
| K190025 — EVOL® -SI Joint Fusion System | Cutting Edge Spine, LLC Aug 12, 2019 |
| K190870 — Cervical Spinal Truss System-Stand Alone (CSTS-SA) | 4Web, Inc. Aug 12, 2019 |
| K191311 — ATEC Lateral Interbody System | Alphatec Spine, Inc. Aug 12, 2019 |
| K190491 — Blue Sky Bio Zygomatic Implant System | Blue Sky Bio, LLC Aug 12, 2019 |
| K183182 — Critical Care Suite | Ge Medical Systems, LLC Aug 12, 2019 |
| K183647 — SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Accessories) | Olympus Surgical Technologies America Aug 9, 2019 |
| K191560 — Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | Vascular Solutions, LLC Aug 9, 2019 |
| K183203 — ELAN 4 Tools | Aesculap, Inc. Aug 9, 2019 |
| K191114 — Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle | Avenu Medical Aug 9, 2019 |
| K182881 — Bone Screw, Bone Tack | Osstem Implant Co., Ltd. Aug 9, 2019 |
| K191884 — DR 100s | Agfa N.V. Aug 9, 2019 |
| K191233 — ARIETTA 750 | Hitachi Healthcare Americas Aug 9, 2019 |
| K191798 — Versana Active | GE Medical Systems Ultrasound And Primary Care Diagnostics Aug 9, 2019 |
| K191792 — Versana Balance | GE Medical Systems Ultrasound And Primary Care Diagnostics Aug 9, 2019 |
| K190371 — Morpheus-C | Biogennix, LLC Aug 9, 2019 |
| K183158 — NxStage Cartridge Express with Speedswap | Nxstage Medical, Inc. Aug 9, 2019 |