| K182000 — AQrate Robotic Assistance System | Globus Medical, Inc. Jan 29, 2019 |
| K182521 — FastPack IP Sex Hormone Binding Globulin Immunoassay | Qualigen, Inc. Jan 29, 2019 |
| K181580 — Cortex CAD/CAM Abutments | Cortex Dental Implants Industries , Ltd. Jan 29, 2019 |
| K181048 — Neo Cage System TM | Neo Medical SA Jan 29, 2019 |
| K181893 — T-PLUS | Wintecare SA Jan 29, 2019 |
| K183022 — Solitaire 4 Revascularization Device | Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Jan 29, 2019 |
| K182093 — ZOLL ECG Analysis Software | Zoll Manufacturing Corporation Jan 28, 2019 |
| K183001 — WEGO-PGLA RAPID | Foosin Medical Supplies Inc., Ltd. Jan 28, 2019 |
| K182477 — Cervical Spacer | Additive Implants, LLC Jan 28, 2019 |
| K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | Zimmer, Inc. Jan 28, 2019 |
| K183456 — Aloka Arietta 850 | Hitachi Healthcare Americas Jan 28, 2019 |
| K183025 — MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component | B-One Ortho, Corp. Jan 28, 2019 |
| K183004 — WEGO-PGA RAPID | Foosin Medical Supplies Inc., Ltd. Jan 28, 2019 |
| K182228 — MIS LOCKiT Abutments System, OT-Equators and Ball Attachments | Mis Implants Technologies , Ltd. Jan 28, 2019 |
| K181775 — Quantum Blood and IV Fluid Infusion Warmer | Life Warmer, Inc. Jan 28, 2019 |
| K183362 — Venue GO | GE Medical Systems Ultrasound And Primary Care Diagnostics Jan 28, 2019 |
| K180822 — VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System | Wenzel Spine, Inc. Jan 28, 2019 |
| K173743 — Greenmedi Safety Filter Syringe | Sang-A Frontec Co., Ltd. Jan 28, 2019 |
| K182919 — SI-Restore® Sacroiliac Joint Fixation System | Biofusion Medical Jan 25, 2019 |
| K183321 — Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. Jan 25, 2019 |
| K183042 — SMR Lateralized Connectors with screws | Lima Corporate S.P.A. Jan 25, 2019 |
| K182968 — Hoffmann LRF System | Stryker GmbH Jan 25, 2019 |
| K183631 — medi pneumatic compression system (pcs) brio (Model 651) | Medi USA, LP Jan 25, 2019 |
| K182389 — Sysmex XN-L Automated Hematology Analyzer | Sysmex America, Inc. Jan 25, 2019 |
| K183615 — Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle | Avenu Medical, Inc. Jan 25, 2019 |
| K180230 — NEST Interbody System | Paonan Biotech Co., Ltd. Jan 25, 2019 |
| K183228 — HammerToe Compression System | Paragon 28, Inc. Jan 25, 2019 |
| K182548 — Accucuff Cuff Pressure Indicator | Tianjin Medis Medical Device Co., Ltd. Jan 25, 2019 |
| K183468 — Revive Reusable Bladder Support | Rinovum Subsidiary 2, LLC Jan 25, 2019 |
| K182895 — Wilson-Cook Achalasia Balloon | Wilson-Cook Medical, Inc. Jan 25, 2019 |
| K182480 — Earlens Contact Hearing Aid | Earlens Corporation Jan 25, 2019 |
| K182078 — MiniCollect K2E K2EDTA Tubes | Greiner Bio-One Na, Inc. Jan 25, 2019 |
| K180780 — microINR System | Iline Microsystems, S.L. Jan 25, 2019 |
| K182642 — GenesisZr 4Y Zirconia | United Dental Resources Corporation Jan 25, 2019 |
| K180183 — Ritter Dental Implant System | Ritter Implants GmbH & Co. KG Jan 24, 2019 |
| K182297 — Surveyor S2 | Mortara Instrument, Inc. Jan 24, 2019 |
| K182312 — Zyppah Anti-Snoring Device | Always More Marketing Jan 24, 2019 |
| K182363 — BTL-703 | BTL Industries, Inc. Jan 24, 2019 |
| K181056 — Reprocessed CS Diagnostic Electrophysiology Catheter | Stryker Sustainability Solutions Jan 24, 2019 |
| K182594 — E-CUBE i7 | Alpinion Medical Systems Co., Ltd. Jan 24, 2019 |
| K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation Jan 24, 2019 |
| K182514 — Surgical Face Mask | Xiantao Zhibo Non-Woven Products Co., Ltd. Jan 24, 2019 |
| K183346 — FLOW 90 Wand | ArthroCare Corporation Jan 24, 2019 |
| K183244 — MAGNETOM Lumina | Siemens Medical Solutions USA, Inc. Jan 24, 2019 |
| K182964 — ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) Jan 24, 2019 |
| K183541 — ProRad 2FC and ProRad 3NC Stationary Radiographic Systems | Prognosys Medical Systems Private Limited Jan 24, 2019 |
| DEN180047 — Aptima Mycoplasma genitalium Assay | Hologic, Inc. Jan 23, 2019 |
| K181956 — Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation Jan 23, 2019 |
| K183151 — Optilite IgA CSF Kit | The Binding Site Group , Ltd. Jan 23, 2019 |
| K181387 — Pre-Formed Penile Silicone Block | International Medical Devices, Inc. Jan 23, 2019 |