| K183113 — DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC Mar 13, 2019 |
| K190311 — BIOK7600 Flat Panel Detector | Biokinemetrics, Inc. Mar 13, 2019 |
| K183610 — Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces | Bovie Medical Corporation Mar 12, 2019 |
| K183446 — BioPlex 2200 Lyme Total | Bio-Rad Laboratories Mar 12, 2019 |
| K183524 — VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) | bioMerieux, Inc. Mar 12, 2019 |
| K183469 — Microlife Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH Mar 12, 2019 |
| K181610 — ActivOrtho Nitinol Compression Screw System | Activortho, Inc. Mar 12, 2019 |
| DEN180017 — Quantra Hemostasis Analyzer, QPlus Cartridge | Hemosonics, LLC Mar 12, 2019 |
| K183180 — Caiman 5 Maryland | Aesculap, Inc. Mar 12, 2019 |
| K182771 — ISS-JAZZ Screw System and JAZZ CAP SP | Implanet, S.A. Mar 12, 2019 |
| K183437 — AirRay Subdural Cortical Electrodes | Cortec GmbH Mar 12, 2019 |
| K183603 — INnate Cannulated Screw System | Exsomed Corporation Mar 12, 2019 |
| K183176 — Endotoxin Activity Assay (EAA) | Spectral Medical, Inc. Mar 12, 2019 |
| K183440 — CRYOcheck FVIII Inhibitor Kit | Precision Biologic, Inc. Mar 12, 2019 |
| K181447 — Safety insulin needle for single use | Berpu Medical Technology Co., Ltd. Mar 12, 2019 |
| K183232 — Double ENDOBUTTON Fixation Device | Smith And Nephew, Inc. Mar 12, 2019 |
| K182313 — BoneTrust Implant System | Medical Instinct Deutschland GmbH Mar 11, 2019 |
| K182241 — Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs | Sri Trang Gloves (Thailand) Co., Ltd. Mar 11, 2019 |
| K182553 — Inno-Pathwire | Suzhou Innomed Medical Device Co., Ltd. Mar 11, 2019 |
| K182789 — KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. Mar 11, 2019 |
| K182013 — EasyInstruments | Agency For Medical Innovations GmbH Mar 11, 2019 |
| K183236 — Rotium Bioresorbable Wick | Nanofiber Solutions, LLC Mar 11, 2019 |
| K181823 — KardiaAI | AliveCor, Inc. Mar 11, 2019 |
| K190253 — EVOS Small Fragment Upper Extremity Plates Line Additions | Smith & Nephew, Inc. Mar 11, 2019 |
| K190039 — EchoSure Diagnostic Ultrasound System | Sonavex, Inc. Mar 8, 2019 |
| K183177 — Nitinol Thermocouple (TCN) Electrode | Boston Scientific Corporation Mar 8, 2019 |
| K190153 — RadiForce MX216 | Eizo Corporation Mar 8, 2019 |
| K183448 — NewTom 5G XL | Cefla S.C. Mar 8, 2019 |
| K182537 — RADMAX Digital Imaging Software | DRGEM Corporation Mar 8, 2019 |
| K190146 — Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation Mar 8, 2019 |
| K173064 — ZAPnea Oral Appliance | B. Fareid, Dds, PC Mar 8, 2019 |
| K190276 — Provident II Hip Stem | Stelkast, Inc. Mar 8, 2019 |
| K190256 — Rulo Radiofrequency Lesion Probe | Epimed International, Inc. Mar 8, 2019 |
| K182995 — Bariatric Power Positioning System (BPPS) | Motion Concepts Mar 8, 2019 |
| K182799 — Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads | Arthrex, Inc. Mar 8, 2019 |
| K190224 — Medline Burn and Wound Dressing (OTC) | Medline Industries, Inc. Mar 8, 2019 |
| K183085 — CoreDx Pulmonary Mini-Forceps | Boston Scientific Corporation Mar 8, 2019 |
| K183285 — cmTriage | Curemetrix, Inc. Mar 8, 2019 |
| K183092 — Kuros TLIF Cage | Kuros Biosciences B.V Mar 8, 2019 |
| K183303 — Brainsway Deep TMS System | Brainsway , Ltd. Mar 8, 2019 |
| K190201 — CORUS Spinal System | Providence Medical Technology, Inc. Mar 8, 2019 |
| K190206 — DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mar 8, 2019 |
| K173518 — Spectrum Spine Expandable Cages (SSEC) | Spectrum Spine, LLC Mar 7, 2019 |
| K190141 — HANAROSTENT LowAx Colon/Rectum (NNN) | M.I.Tech Co., Ltd. Mar 7, 2019 |
| K183373 — Bonebridge | Med-El Elektromedizinische Geraete GmbH Mar 7, 2019 |
| K181165 — Philips wearable biosensor-G5 Solution | Connected Sensing- A Division Of Philips Medical Systems Mar 7, 2019 |
| K182344 — RhythmAnalytics | Biofourmis Singapore Pte., Ltd. Mar 7, 2019 |
| K190098 — Endophys Pressure Sensing Sheath | Endophys Holdings, LLC Mar 7, 2019 |
| K182311 — Cervella | Innovative Neurological Devices, LLC Mar 7, 2019 |
| K183551 — VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) | bioMerieux, Inc. Mar 7, 2019 |