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

FPA 2025-06-05

Clave™ Neutral-Displacement Needlefree Connectors

Applicant Icu Medical, Inc.

K-Number K250616

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OWQ 2025-06-05

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K250545

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CAW 2025-06-05

Portable Oxygen Concentrator (Spirit-3)

Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K-Number K242736

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MSX 2025-06-05

Central Station

Applicant Nihon Kohden Digital Health Solutions, LLC

K-Number K242750

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LLZ 2025-06-05

TechLive

Applicant DeepHealth, Inc.

K-Number K243703

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QIH 2025-06-05

BrightHeart View Classifier

Applicant Brightheart

K-Number K251456

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GZI 2025-06-05

Synchrony (20-3000)

Applicant Synapse Biomedical, Inc.

K-Number K242704

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EIH 2025-06-05

zirkon; structure; LFU shades, stains and glazes

Applicant Estetic Ceram AG

K-Number K251084

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LPH 2025-06-05

Trinity EVO Acetabular Shell

Applicant Corin U.S.A. Limited

K-Number K242744

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EOB 2025-06-05

Portare System (FA-001)

Applicant Grumpy Innovation, Inc.

K-Number K243639

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DRG 2025-06-04

TeleRehab Aermos Cardiopulmonary Rehabilitation

Applicant The ScottCare Corporation

K-Number K250259

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LNH 2025-06-04

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

Applicant Philips Medical Systems Nederland B.V.

K-Number K251397

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