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

FXX 2021-06-22

Disposable Surgical Mask

Applicant Safeway Industry Healthcare.

K-Number K210840

View Details →

GEX 2021-06-22

Fotona XPulse Pro Laser Platform

Applicant Fotona D.O.O.

K-Number K202991

View Details →

NUV 2021-06-22

ICOONE Laser Med (also referred to as ICOONE Medical laser)

Applicant I-Tech Industries Srl

K-Number K211272

View Details →

IRP 2021-06-22

Air Pressure Therapy System

Applicant Xiamen Weiyou Intelligent Technology Co., Ltd.

K-Number K201935

View Details →

JAK 2021-06-22

MICROMATE

Applicant Isys Medizintechnik GmbH

K-Number K203720

View Details →

QJF 2021-06-22

MolecuLight I:X

Applicant MolecuLight, Inc.

K-Number K210882

View Details →

LZA 2021-06-21

Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green

Applicant Shen Wei USA, Inc.

K-Number K202085

View Details →

DZJ 2021-06-21

coDiagnostiX

Applicant Dental Wings GmbH

K-Number K193301

View Details →

MUE 2021-06-21

2430MCA with Xmaru W

Applicant Rayence Co., Ltd.

K-Number K202902

View Details →

DZE 2021-06-21

Straumann BLX Implant System

Applicant Institut Straumann AG

K-Number K210855

View Details →

DZB 2021-06-21

Orthodontic Facemask

Applicant Ita.O Italian Orthodontic System S.R.L.

K-Number K202855

View Details →

NKB 2021-06-21

Posterior Spinal Fixation System

Applicant Shanghai Reach Medical Instrument Co, Ltd.

K-Number K201737

View Details →

Page 1394 of 2744

↑