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

DQK 2025-12-19

STAR Apollo Mapping System

Applicant Rhythm AI, Ltd.

K-Number K253733

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HRS 2025-12-19

Pectus Versa System

Applicant Gm Dos Reis Industria E Comercio

K-Number K251050

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JEY 2025-12-19

Southern Craniomaxillofacial (CMF) System

Applicant Southern Medical (Pty) , Ltd.

K-Number K253373

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HGX 2025-12-19

Wearable Electric Breast Pump (YM-8803)

Applicant Guangdong Youmeng Electrical Technology Co., Ltd.

K-Number K252754

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CJE 2025-12-19

Tru Liver Health Test Panel

Applicant Truvian Health

K-Number K251074

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FAD 2025-12-19

Endura Ureteral Stent and Stent Set

Applicant Cathegenix (Xiamen) Co., Ltd.

K-Number K251469

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IZL 2025-12-19

Airbile-100

Applicant Poskom Co., Ltd.

K-Number K250976

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DRE 2025-12-19

ProtekDilate Vascular Access Kit

Applicant Sorin Group Italia S.R.L.

K-Number K253616

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LNH 2025-12-19

MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise

Applicant Siemens Healthcare GmbH

K-Number K252838

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KGN 2025-12-19

MatriDerm pluS+ Bi-Layer

Applicant Medskin Solutions Dr. Suwelack AG

K-Number K250864

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MXD 2025-12-18

Assert-IQ (DM5100)

Applicant ABBOTT MEDICAL

K-Number K253516

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FDX 2025-12-18

Single Use Cytology Brush V (BC-V600P-3010)

Applicant Olympus Medical Systems Corporation

K-Number K250993

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