| K190187 — Gynescope System | Illumigyn , Ltd. May 8, 2019 |
| K190147 — COLOSSEUM Mesh | Globus Medical, Inc. May 8, 2019 |
| K183443 — SomnoDent Avant | Somnomed, Inc. May 8, 2019 |
| K183461 — Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. May 8, 2019 |
| K191011 — Scope ProTech | Meditech Endoscopy, Ltd. May 7, 2019 |
| K183701 — Stryker ChestShield Sterilization Tray System | Paragon Medical May 7, 2019 |
| K183016 — SteriCap Mini Needle | Ocujet, LLC May 7, 2019 |
| K183432 — cobas u 601 urinalysis test system | Roche Diagnostics May 7, 2019 |
| K190649 — FUJIFILM Endoscope Model EC-760S-V/L | Fujifilm Corporation May 7, 2019 |
| K182865 — Neodent Instruments Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. May 7, 2019 |
| K181854 — OssBuilder System | Osstem Implant Co., Ltd. May 7, 2019 |
| K183512 — Moore Park Mask | Resmed, Ltd. May 7, 2019 |
| K190161 — Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray | Gebauer Company May 7, 2019 |
| K190165 — Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. May 6, 2019 |
| K190941 — BioCardia 8.5 F Avance Steerable lntroducer | Biocardia, Inc. May 6, 2019 |
| K190182 — Unity Subcutaneous Delivery System for Remodulin | DEKA Research & Development May 6, 2019 |
| K190159 — Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove | Showa Best Glove, Inc. May 6, 2019 |
| K190362 — HealthPNX | Zebra Medical Vision, Ltd. May 6, 2019 |
| K190900 — Biograph Vision | Siemens Medical Solutions USA, Inc. May 6, 2019 |
| K182460 — MD-6000P Bladder Scanner | MEDA Co., Ltd. May 6, 2019 |
| K190643 — Medline Electrocautery Pencil | Medline Industries, Inc. May 6, 2019 |
| K182437 — Wireless Intelligent Thermometer | Shenzhen Jumper Medical Equipment Co., Ltd. May 5, 2019 |
| K183577 — Medline Quick-Clear Wand | Medline Industries, Inc. May 4, 2019 |
| K190287 — Arthrex DynaNite® PIP (Hammertoe) Implant | Arthrex, Inc. May 3, 2019 |
| K180309 — Manual Wheelchair W54 | Jiangsu Jumao Medical Equipment Co., Ltd. May 3, 2019 |
| K190879 — N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH May 3, 2019 |
| K183188 — Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF | Richard Wolf Medical Instruments Corporation May 3, 2019 |
| K190222 — FilmArray Pneumonia/Pneumoniaplus Control | Maine Molecular Quality Controls, Inc. May 3, 2019 |
| K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent, Inc. May 3, 2019 |
| K190083 — Leaf Photocoagulator | Norlase Aps May 3, 2019 |
| K190504 — Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | Relievant Medsystems May 3, 2019 |
| K190278 — AuraGen 123 Suction Lipoplasty System (A123) | Auragen Aesthetics, LLC May 3, 2019 |
| K182877 — HALF DOME Posterior Lumbar Interbody System | Astura Medical, LLC May 3, 2019 |
| K190409 — MatrixRIB Fixation System | DePuy Synthes May 3, 2019 |
| K190532 — TruDi NAV Wire | Acclarent, Inc. May 3, 2019 |
| K190266 — NeoLSD MSMS Kit | Perkinelmer, Inc. May 3, 2019 |
| K182430 — CLEARFIL MAJESTY IC | Kuraray Noritake Dental, Inc. May 3, 2019 |
| K190599 — Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC May 3, 2019 |
| K182118 — armor LC | Mavrik Dental Systems, Ltd. May 3, 2019 |
| K183199 — TRIO Handpiece | Omniguide, Inc. May 2, 2019 |
| K190851 — HYDRASHIFT 2/4 daratumumab | Sebia May 2, 2019 |
| K190540 — Ponto 4 | Oticon Medical AB May 2, 2019 |
| K181671 — Cocoon Convective Warming System | Care Essentials Pty, Ltd. May 2, 2019 |
| K190376 — PASS LP Spinal System | Medicrea International SA May 2, 2019 |
| K182474 — alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | Biosystems S.A. May 2, 2019 |
| K190233 — K-Shield Advantage Port Access Infusion Set (PAIS) | Kawasumi Laboratories, Inc. May 2, 2019 |
| K190560 — SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface | Nonin Medical, Inc. May 2, 2019 |
| K180510 — NS 120P-TRS Airway Pressure Gauge | Instrumentation Industries, Inc. May 1, 2019 |
| K190843 — Synchro2 Support Guidewire | Stryker May 1, 2019 |
| K190817 — HS Fiber | Riverpoint Medical May 1, 2019 |