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

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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NXC 2022-08-31

MyClearALIGN Dental Aligner System

Applicant Key Dental Technologies, LLC

K-Number K221475

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NKB 2022-08-31

Sterile Posterior Spinal Fixation System

Applicant Shanghai Reach Medical Instrument Co, Ltd.

K-Number K221745

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PDU 2022-08-31

LimFlow ARC

Applicant LimFlow, Inc.

K-Number K221541

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LHI 2022-08-31

Vented Vial Adapter 20mm

Applicant West Pharma. Services IL, Ltd.

K-Number K213513

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HRS 2022-08-31

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)

Applicant I.T.S. GmbH

K-Number K210935

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