Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

HWC 2018-12-18

Arthrex Compression FT Screws

Applicant Arthrex, Inc.

K-Number K182361

View Details →

DHR 2018-12-18

EliA RF IgM Immunoassay

Applicant Phadia AB

K-Number K182747

View Details →

EBI 2018-12-18

Lucitone Denture Base Materials

Applicant Dentsply Sirona

K-Number K182422

View Details →

NRY 2018-12-18

Riptide Aspiration System (Riptide Large Bore Aspiration System)

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K183185

View Details →

FMF 2018-12-17

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)

Applicant Novo Nordisk, Inc.

K-Number K182387

View Details →

KWQ 2018-12-17

Met One Czar Anterior Cervical Plate System

Applicant Met One Technologies

K-Number K180772

View Details →

QEW 2018-12-17

FlowTriever Retrieval/Aspiration System

Applicant Inari Medical

K-Number K183198

View Details →

MCW 2018-12-17

Phoenix 2.4mm Atherectomy Plus System

Applicant Volcano Atheromed, Inc.

K-Number K181877

View Details →

MWI 2018-12-17

Handheld VitalSigns Monitoring System

Applicant Visiomed Technology Co.,Ltd

K-Number K172965

View Details →

PSZ 2018-12-17

Acucy Influenza A&B Test with the Acucy System

Applicant SEKISUI Diagnostics, LLC

K-Number K182001

View Details →

DQD 2018-12-17

Tyto Stethoscope (OTC)

Applicant Tyto Care , Ltd.

K-Number K181612

View Details →

DXQ 2018-12-17

Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff

Applicant Shenzhen Caremed Medical Technology Co., Ltd.

K-Number K182433

View Details →

Page 1925 of 2685

↑