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

QIH 2025-04-30

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program

Applicant Canon Medical Systems Corporation

K-Number K250328

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DXN 2025-04-30

Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K-Number K244000

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JPA 2025-04-30

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

Applicant Haemonetics

K-Number K251024

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OVD 2025-04-30

Stable-L Lumbar Interbody System

Applicant Nexus Spine, LLC

K-Number K243934

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DWJ 2025-04-30

Arctic Sun Stat Temperature Management System

Applicant Medivance, Inc.

K-Number K243942

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DYB 2025-04-30

AuST Steerable Sheath

Applicant CenterPoint Systems, LLC

K-Number K251051

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OWB 2025-04-30

Persona C HR

Applicant A.T.S. Applicazione Tecnologie Speciali S.R.L.

K-Number K250282

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NRY 2025-04-30

APRO 45 Catheter and Alembic Aspiration Tubing

Applicant Alembic, LLC

K-Number K251015

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BTR 2025-04-29

LMA Fastrach ETT SU

Applicant Teleflex Medical

K-Number K242495

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HRS 2025-04-29

Pediatric Plating Platform Hip

Applicant OrthoPediatrics Corp.

K-Number K243963

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KGC 2025-04-29

PUMA-G Pediatric System

Applicant Coaptech, Inc.

K-Number K242211

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KNW 2025-04-29

ExpressCore Biopsy Device

Applicant Inrad, Inc.

K-Number K243886

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