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

HRS 2022-09-02

Bonebridge Osteosynthesis Plating System

Applicant Bonebridge AG

K-Number K213864

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FXX 2022-09-02

Savewo ClassicMASK

Applicant Savewo Limited

K-Number K221957

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NUH 2022-09-01

Wireless TENS/EMS, Bruno, Aela

Applicant Zmi Elecronics , Ltd.

K-Number K220997

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SBF 2022-09-01

Knee+

Applicant Pixee Medical

K-Number K220104

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GEX 2022-09-01

FOX 810, FOX 980

Applicant A.R.C Laser GmbH

K-Number K220531

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FXX 2022-09-01

Disposable Medical Masks

Applicant Hantech Medical Device Co., Ltd.

K-Number K221038

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QFM 2022-09-01

DrAid for Radiology v1

Applicant Vinbrain Joint Stock Company

K-Number K221241

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OBP 2022-09-01

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K

Applicant Magnus Medical, Inc.

K-Number K220177

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QTV 2022-09-01

Soteria Bed Barrier

Applicant Trinity Guardion

K-Number K201876

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EHD 2022-09-01

Hybrid C70

Applicant Digimed Co., Ltd.

K-Number K220579

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GEI 2022-09-01

Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System

Applicant ArthroCare Corporation

K-Number K220563

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NHN 2022-09-01

Erchonia GVL

Applicant Erchonia Corporation

K-Number K221987

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