| K190433 — cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. May 22, 2019 |
| K183242 — ET IV SA Dental Implants | Hiossen, Inc. May 21, 2019 |
| K182576 — Solax Powered Wheelchair | Dongguan Prestige Sporting Goods Co., Ltd. May 21, 2019 |
| K182342 — IntraLock Lapidus System | Fusion Orthopedics, LLC May 21, 2019 |
| K183646 — Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure | Edwards Lifeciences, LLC May 21, 2019 |
| K190367 — Smith & Nephew Tablet Application | Smith & Nephew May 21, 2019 |
| K182711 — Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. May 21, 2019 |
| K182975 — MAKO 7 | Boston Scientific Corporation May 21, 2019 |
| K183655 — VersaCross Transseptal Sheath | Baylis Medical Company, Inc. May 20, 2019 |
| K190332 — Aperio AT2 DX System | Leica Biosystems Imaging, Inc. May 20, 2019 |
| K182235 — OnSite Waste Sharps Container | Bluestone Medical, Inc. May 20, 2019 |
| K190134 — Full Automatic (NIBP) Blood Pressure Monitor-HL158TB | Health & Life Co., Ltd. May 20, 2019 |
| DEN180059 — Nerivio Migra | Theranica Bioelectronics , Ltd. May 20, 2019 |
| K190125 — FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | T.A.G. Medical Products Corporation, Ltd. May 19, 2019 |
| K183597 — QIAstat-Dx Respiratory Panel | QIAGEN GmbH May 18, 2019 |
| K191025 — DRX-Revolution Mobile X-ray System | Carestream Health, Inc. May 17, 2019 |
| K191029 — Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac | Medtronic, Inc. May 17, 2019 |
| K183381 — Navigation Enabled Instruments | Stryker May 17, 2019 |
| K191015 — Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) | Cook Incorporated May 17, 2019 |
| K183035 — Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | Cook Incorporated May 17, 2019 |
| K183618 — Revolution Radial Head | Ignite Orthopedics, Inc. May 17, 2019 |
| K182252 — Cook Unimpregnated Central Venous Catheter | Cook Incorporated May 17, 2019 |
| K183077 — Delta Xtend Reverse Shoulder System | Depuy(Ireland) May 17, 2019 |
| K173570 — SD Abutment | Surgident Co., Ltd. May 17, 2019 |
| K182394 — WiZARD 310/320 Series CPAP Mask | Apex Medical Corp. May 17, 2019 |
| K183505 — KY Banksy Moisture | Rb Health (Us), LLC May 17, 2019 |
| K182302 — CardioGard Emboli Protection Cannula | Cardiogard Medical, Ltd. May 17, 2019 |
| K183417 — iRestore Professional 282 | Freedom Laser Therapy, Inc. May 17, 2019 |
| K190675 — Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics, Inc. May 17, 2019 |
| K191040 — syngo.via (Version VB40A) | Siemens Healthcare GmbH May 16, 2019 |
| K191051 — ARGOS | Santec Corporation May 16, 2019 |
| K191000 — Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. May 16, 2019 |
| K190372 — Aveta System | Meditrina, Inc. May 16, 2019 |
| K190355 — Precision Casting Solutions Total Knee System | Precision Casting Solutions, Inc. May 16, 2019 |
| K182734 — Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac | Unicon Optical Co., Ltd. May 16, 2019 |
| K183534 — Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. May 16, 2019 |
| K190345 — VPC | PAJUNK GmbH Medizintechnologie May 16, 2019 |
| K191023 — Dolphin/IQ, Dolphin/4D and Dolphin/MAX | Viasonix , Ltd. May 16, 2019 |
| K182251 — EVOLUTION NitrX Medial-Pivot Knee | Mircoport Orthopedics, Inc. May 16, 2019 |
| K190472 — Aptima CV/TV Assay | Hologic, Inc. May 16, 2019 |
| K173895 — Tel-O-Graph | I.E.M. Industrielle Entwicklung And Medizintechnik May 16, 2019 |
| K183697 — Masimo Rad-97 and Accessories | Masimo Corporation May 15, 2019 |
| K190493 — Recovery Pump, 737R (RPX) | Mego Afek AC , Ltd. May 15, 2019 |
| K183277 — SpO2 Sensor | Shenzhen Upnmed Equipment Co., Ltd. May 15, 2019 |
| K190405 — BACT/ALERT MP Reagent System | bioMerieux, Inc. May 15, 2019 |
| K182328 — VeriClear Digital Early Result Pregnancy Test | True Diagnostics, Inc. May 15, 2019 |
| K190034 — REMY Medical Therapy Laser System | Footdocprenur, LLC May 15, 2019 |
| K182602 — SOFIA EX Intracranial Support Catheter | MicroVention, Inc. May 15, 2019 |
| K183648 — APAS Independence with Urine Analysis Module | Clever Culture Systems AG May 15, 2019 |
| K190584 — CAYMAN LP Plate System | K2M, Inc. May 15, 2019 |