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

QQV 2023-03-20

Colibrí

Applicant Copan Wasp Srl

K-Number K223245

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NUH 2023-03-20

TENS and EMS Stimulation (OTC)

Applicant Changsha Yuwen Medical Equipment Co., Ltd.

K-Number K230174

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FMI 2023-03-20

Shina Safety Needle

Applicant Shina Corporation

K-Number K222417

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CIG 2023-03-20

Atellica® CH Diazo Total Bilirubin (D_TBil)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K222104

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NUH 2023-03-20

TENS and EMS Stimulation (OTC)

Applicant Changsha Yuwen Medical Equipment Co., Ltd.

K-Number K230163

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LNH 2023-03-20

MOBINEURO Alita Intraoperative MRI System

Applicant Sino Canada Health Engineering Research Institute (Hefei)

K-Number K223875

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GEI 2023-03-20

HPR45i

Applicant F Care Systems USA, LLC

K-Number K220725

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LHN 2023-03-20

P-Cure Proton Beam Therapy System

Applicant P-Cure, Ltd.

K-Number K221996

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ODP 2023-03-20

The Integrity Spine Core System

Applicant Integrity Spine

K-Number K223043

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GCJ 2023-03-20

Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A

Applicant Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd

K-Number K222828

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BTM 2023-03-18

EOlife®

Applicant Archeon

K-Number K221841

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NPM 2023-03-18

InterOss Collagen

Applicant Sigmagraft, Inc.

K-Number K221808

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