| K190391 — TDM Plate and Screw Systems | Tdm Co., Ltd. Nov 15, 2019 |
| K191201 — EM SA Implant System | Hiossen, Inc. Nov 15, 2019 |
| K192940 — CoolTone | Zimmer Medizinsysteme GmbH Nov 15, 2019 |
| K190312 — Dornier Ureteral Stent | Dornier Medtech America, Inc. Nov 15, 2019 |
| K182672 — ROSA Bracket | Gni Co., Ltd. Nov 15, 2019 |
| K192289 — IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit | Irras USA, Ltd. Nov 15, 2019 |
| K183598 — KeyPrint KeySplint Soft | Keystone Industries Nov 15, 2019 |
| K192113 — DRSplus | Centervue S.P.A. Nov 15, 2019 |
| K192045 — Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. Nov 15, 2019 |
| K191280 — E-100 Electrosurgical Generator, SynchroSeal | Intuitive Surgical, Inc. Nov 14, 2019 |
| K183666 — EBA One Nailing System | Citieffe S.R.L. Nov 14, 2019 |
| K192355 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) | Beckman Coulter, Inc. Nov 14, 2019 |
| K190478 — Reprocessed ViewFlex Xtra ICE Catheter | Sterilmed, Inc. Nov 14, 2019 |
| K192347 — ST Internal Implant System | Megagen Implant Co., Ltd. Nov 14, 2019 |
| K192911 — Brainlab Compatible K2M Navigation Instruments | K2M, Inc. Nov 14, 2019 |
| K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | Wilson-Cook Medical, Inc. Nov 14, 2019 |
| K190721 — LongBow Ti | Life Spine, Inc. Nov 14, 2019 |
| K191110 — HeraBEAT US | Heramed, Ltd. Nov 14, 2019 |
| K190522 — Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) | Allwin Medical Devices, Inc. Nov 14, 2019 |
| K191976 — Piper GO-IO Intraosseous Infusion System | Piper Access, LLC Nov 13, 2019 |
| K192915 — GMA 2.0 Pedicle Screw System | Grafton Medical Alliance Nov 13, 2019 |
| K191171 — EchoGo Core | Ultromics, Ltd. Nov 13, 2019 |
| K191570 — Infrared Thermometer Model MD-H30 | Guangzhou Berrcom Medical Device Co., Ltd. Nov 13, 2019 |
| K192150 — AMICUS Separator System | Fresenius Kabi AG Nov 13, 2019 |
| K192469 — Nox Sleep System | Nox Medical Nov 13, 2019 |
| K191477 — AEON-C Stand Alone System | Huvexel Co. , Ltd. Nov 13, 2019 |
| K192582 — NuVasive CoRoent Small Interlock System | Nu Vasive, Incorporated Nov 13, 2019 |
| K191161 — xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc. Nov 12, 2019 |
| K191972 — ARIX Wrist System | Jeil Medical Corporation Nov 12, 2019 |
| K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP) | Arrow International, Teleflex Nov 12, 2019 |
| K192968 — IDENTIFY | Varian Medical Systems, Inc. Nov 12, 2019 |
| K192331 — LaseMD LEO Laser System | Lutronic Global Nov 12, 2019 |
| K192202 — Clear21 | World Class Technology Corporation Nov 12, 2019 |
| K192932 — FDR D-EVO III flat panel detector system | Fujifilm Corporation Nov 12, 2019 |
| K190799 — PENTAX Medical Video Upper GI Scopes (EG Family) | Pentax Of America, Inc. Nov 12, 2019 |
| K192661 — LATERA Absorbable Nasal Implant System | Entellus Medical, Inc. (Aka Stryker Ent) Nov 10, 2019 |
| K191986 — DESS Dental Smart Solutions | Terrats Medical SL Nov 10, 2019 |
| K190661 — Omics Core | Nanthealth, Inc. Nov 9, 2019 |
| K190958 — Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. Nov 9, 2019 |
| K192264 — HIVOX Spopad EMS SP-911, SP-921 | Hivox Biotek, Inc. Nov 8, 2019 |
| K192432 — IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 | Shenzhen Bosidin Technology Co., Ltd. Nov 8, 2019 |
| K191237 — CERENOVUS Large Bore Catheter | Codman & Shurtleff, Inc. Nov 8, 2019 |
| K191959 — QuantX Breast MRI Biopsy Guidance Plugin | Qlarity Imaging Nov 8, 2019 |
| K191527 — Visalys CemCore, Visalys Cem Core Try In Paste | Kettenbach GmbH & Co. KG Nov 8, 2019 |
| K191286 — CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System | Ascensia Diabetes Care Nov 8, 2019 |
| K192118 — CRP Vario | SENTINEL CH. SpA Nov 8, 2019 |
| K192049 — Oryx Cervical Plate System | Innovasis, Inc. Nov 8, 2019 |
| K192403 — VK100 Percutaneous Vertebral Augmentation System | Bonwrx, Ltd. Nov 8, 2019 |
| K191230 — Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | O&M Halyard, Inc. Nov 8, 2019 |
| K192297 — APTUS Wrist Arthrodesis Plates | Medartis AG Nov 8, 2019 |