Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

FYA 2020-12-31

Surgical Gown (Sterile), Surgical Gown (Non-sterile)

Applicant B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

K-Number K202706

View Details →

NGX 2020-12-31

NuEra Tight Family, EMS Model

Applicant Bios S.R.L.

K-Number K201239

View Details →

HPS 2020-12-30

CryoTreQ

Applicant VitreQ BV

K-Number K202038

View Details →

ODG 2020-12-30

PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

Applicant Pentax of America, Inc.

K-Number K203166

View Details →

KCT 2020-12-30

CrossRoads Tray System

Applicant Crossroads Extremity Systems, LLC

K-Number K202268

View Details →

DXN 2020-12-30

Upper Arm Electronic Blood Pressure Monitor

Applicant Conmo Electronic Company Limited

K-Number K202372

View Details →

HWC 2020-12-30

Arthrex Low Profile Screws

Applicant Arthrex, Inc.

K-Number K203239

View Details →

GWQ 2020-12-30

NeuroAmp II, NeuroAmp II.5s

Applicant Corscience GmbH & Co. KG

K-Number K193159

View Details →

EZL 2020-12-30

Foley Balloon Catheter for Urology

Applicant Apollon Co., Ltd.

K-Number K201776

View Details →

FXX 2020-12-30

JianYu Surgical Mask

Applicant Jiangsu Jianyu Health Medical Co., Ltd.

K-Number K201754

View Details →

QJY 2020-12-30

Remunity Pump for Remodulin (treprostinil) Injection

Applicant Deka Research and Development

K-Number K202690

View Details →

HRS 2020-12-29

Baby Gorilla/Gorilla Plating System

Applicant Paragon 28, Inc.

K-Number K203511

View Details →

Page 1502 of 2744

↑