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

HAE 2023-03-03

Rebellion, Phantom Multi-Bite Kerrison Rongeur

Applicant Morpheus AG

K-Number K230256

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NDN 2023-03-03

INJECTION PIN (KIP(02031-02061) (03031-03061))

Applicant Slk Ortho, LLC

K-Number K221697

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OHT 2023-03-03

Light Based Hair Removal Device GP592

Applicant Shenzhen Gsd Tech Co., Ltd.

K-Number K230060

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QEP 2023-03-03

Alinity m STI Assay

Applicant Abbott Molecular, Inc.

K-Number K222379

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OZE 2023-03-03

Lyra Influenza A+B Assay

Applicant Quidel Corporation

K-Number K230236

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DXN 2023-03-03

Electronic Sphygmomanometers

Applicant Qingdao Yasee Medical Device Co., Ltd.

K-Number K222394

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HSB 2023-03-03

Dyna Locking Trochanteric Nail

Applicant Innosys

K-Number K221084

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IYO 2023-03-02

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)

Applicant Echosens

K-Number K223902

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EOQ 2023-03-02

iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)

Applicant Boston Scientific Corporation

K-Number K221340

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FMF 2023-03-02

Insulin Syringe

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K223453

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FXX 2023-03-02

Disposable 4 Layers Surgical Face Mask

Applicant Social Medical Supply, LLC

K-Number K230093

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QHA 2023-03-02

AccuFFRangio Plus

Applicant ArteryFlow Technology Co., Ltd.

K-Number K230303

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