| K182886 — Cytomics FC 500 Series (MPL or MCL) Flow Cytometer | Beckman Coulter Sep 6, 2019 |
| K191577 — Willow Wearable Breast Pump 2.0 | Exploramed Nc7, Inc. Sep 6, 2019 |
| K190383 — GM501 Wash | Hamilton Thorne, Inc. Sep 5, 2019 |
| K183563 — Holinwon 30 | Wontech Co., Ltd. Sep 5, 2019 |
| K192123 — HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream | Qingdao Hightop Biotech Co., Ltd. Sep 5, 2019 |
| K192148 — Freedom Primary PCK | Maxx Orthopedics, Inc. Sep 5, 2019 |
| K191625 — Persona Revision Knee System | Zimmer, Inc. Sep 5, 2019 |
| K183419 — EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | Olympus Medical Systems Corp. Sep 5, 2019 |
| K191853 — Dual-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. Sep 5, 2019 |
| K191004 — Advocate Non-Contact Infrared Thermometer | Broadmaster Biotech, Corp. Sep 5, 2019 |
| K183433 — FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation Sep 5, 2019 |
| K190930 — SmarTemp X1 | Parkell, Inc. Sep 5, 2019 |
| K190899 — bili-hut | Little Sparrows Technologies, Inc. Sep 5, 2019 |
| K192119 — 3M Clarity Aligners | 3M Company Sep 5, 2019 |
| K192020 — Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label | STERIS Corporation Sep 5, 2019 |
| K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 | STERIS Corporation Sep 5, 2019 |
| K191710 — FlowTriever Retrieval/Aspiration System | Inari Medical Sep 5, 2019 |
| K192088 — GOLNIT Non-aborbable PTFE Surgical Suture | Antarma, LLC Dba Golnit Sutures Sep 4, 2019 |
| K191034 — VPS Impression Material | Hygedent, Inc. Sep 4, 2019 |
| K192156 — Cartiva SCI instrumentation set | Cartiva, Inc. Sep 4, 2019 |
| K190758 — Opus Bulk Fill APS, Opus Bulk Fill Flow APS | Dentscare Ltda Sep 4, 2019 |
| K192116 — Human IgA liquid reagent kit for Use on SPAPlus | The Binding Site Group , Ltd. Sep 4, 2019 |
| K191070 — Signia Small Diameter Reloads | Covidien Sep 4, 2019 |
| K191179 — Myo Plus | Otto Bock Healthcare Products GmbH Sep 4, 2019 |
| K191908 — MTS Imipenem 0.016-256 µg/mL | Liofilchem S.R.L. Sep 4, 2019 |
| K190844 — Akesis Galaxy | Akesis, Inc. Sep 4, 2019 |
| K192155 — Smith & Nephew DYONICS 25 Fluid Management System | Smith & Nephew, Inc. Sep 4, 2019 |
| K183347 — K3 | Osstem Implant Co., Ltd. Sep 4, 2019 |
| K191503 — MobileRay Pulse SE Digital Imaging System | Portavision Medical, LLC Sep 4, 2019 |
| K191617 — Syntec Tibial Nail System | Syntec Scientific Corporation Sep 3, 2019 |
| K191500 — NuVasive® ACP System | Nu Vasive, Incorporated Sep 3, 2019 |
| K192106 — AcQRef Introducer Sheath | Acutus Medical, Inc. Sep 3, 2019 |
| K182765 — 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe | Top Corporation Sep 3, 2019 |
| K183438 — Geomed Vascular Dilators | Geomed Medizin-Technik GmbH & Co. Sep 3, 2019 |
| K191664 — SelectFlex 072 Neurovascular Access System | Q'Apel Medical Aug 30, 2019 |
| K192058 — EV1000 Clinical Platform NI, EV1000 Clinical Platform | Edwards Lifesciences, LLC Aug 30, 2019 |
| K191415 — Pathfinder Endoscope Overtube | Neptune Medical, Inc. Aug 30, 2019 |
| K190810 — OPERA, OPERA eco | Unimom.Co Aug 30, 2019 |
| K191471 — Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. Aug 30, 2019 |
| K190702 — Lumipulse G whole PTH | Fujirebio Diagnostics,Inc. Aug 30, 2019 |
| K192074 — Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) Aug 30, 2019 |
| K183407 — Triton Cage | Medyssey USA, Inc. Aug 30, 2019 |
| K191732 — Sutter RaVoR Bipolar Electrodes | Sutter Medizintechnik GmbH Aug 30, 2019 |
| K192071 — iNSitu Total Hip System | Theken Companies, LLC Aug 30, 2019 |
| K191547 — ReliefBand | Reliefband Technologies, LLC Aug 30, 2019 |
| K191554 — LightWalker Laser System Family | Fotona D.O.O. Aug 30, 2019 |
| K191786 — Cyclops Anterior Cervical Plate System | Degen Medical, Inc. Aug 30, 2019 |
| K190719 — Artemis Eye System | Penumbra, Inc. Aug 30, 2019 |
| K190449 — Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head | Olympus Medical Systems Corp. Aug 30, 2019 |
| K183475 — T1-CS, T1-C | Osstem Implant Co., Ltd. Aug 30, 2019 |