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

OCL 2021-07-26

AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE

Applicant AtriCure, Inc.

K-Number K210477

View Details →

FXX 2021-07-25

MASC Surgical Mask

Applicant Mid-America Safety Corp.

K-Number K211984

View Details →

FXX 2021-07-24

Medical Face Mask

Applicant Hubei Kangning Protective Products Co., Ltd.

K-Number K211363

View Details →

LYZ 2021-07-24

Disposable Vinyl Nitrile Synthetic Gloves Powder Free

Applicant Tangshan Hongyun Healthcare Products Co., Ltd.

K-Number K211262

View Details →

HWC 2021-07-23

IntraLock System

Applicant Fusion Orthopedics, LLC

K-Number K210159

View Details →

OVE 2021-07-23

Blustone Synergy Diamond SA Cervical System

Applicant Blustone Synergy, LLC

K-Number K210382

View Details →

LZA 2021-07-23

Nitrile Patient Examination Gloves

Applicant Huayuan Medical Technology(Shangqiu) Co., Ltd.

K-Number K211012

View Details →

JWH 2021-07-23

Klassic Knee System

Applicant Total Joint Orthopedics, Inc.

K-Number K211602

View Details →

DQA 2021-07-23

VS Newborn Heart Rate Monitor

Applicant Surepulse Medical Limited

K-Number K201887

View Details →

JWY 2021-07-23

Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)

Applicant Thermo Fisher Scientific

K-Number K202612

View Details →

FXX 2021-07-23

Altor Safety 3-Ply Surgical Mask (Model:62222)

Applicant Altor Safety, LLC

K-Number K211249

View Details →

EOB 2021-07-23

Peregrine Endoscopy System

Applicant 3nt Medical , Ltd.

K-Number K202727

View Details →

Page 1298 of 2685

↑