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

DZE 2021-06-23

S.I.N. Dental Implant System

Applicant S.I.N. - Sistema DE Implante Nacional S.A.

K-Number K203725

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DZE 2021-06-22

AnyOne Onestage Implant System

Applicant Megagen Implant Co., Ltd.

K-Number K210161

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IRP 2021-06-22

LF900

Applicant Daesung Maref Co., Ltd.

K-Number K203019

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FTC 2021-06-22

M Series Phototherapy Equipment

Applicant Daavlin Distributing Co.

K-Number K210881

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MUE 2021-06-22

SenoBright HD

Applicant GE Healthcare

K-Number K211215

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FXX 2021-06-22

Disposable Surgical Mask

Applicant Safeway Industry Healthcare.

K-Number K210840

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GEX 2021-06-22

Fotona XPulse Pro Laser Platform

Applicant Fotona D.O.O.

K-Number K202991

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NUV 2021-06-22

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

Applicant I-Tech Industries Srl

K-Number K211272

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IRP 2021-06-22

Air Pressure Therapy System

Applicant Xiamen Weiyou Intelligent Technology Co., Ltd.

K-Number K201935

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JAK 2021-06-22

MICROMATE

Applicant Isys Medizintechnik GmbH

K-Number K203720

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QJF 2021-06-22

MolecuLight I:X

Applicant MolecuLight, Inc.

K-Number K210882

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LZA 2021-06-21

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

Applicant Shen Wei USA, Inc.

K-Number K202085

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