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

JOJ 2024-04-10

CELERITY HP Indicator Tape

Applicant Steris

K-Number K240760

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LNH 2024-04-10

uMR 680

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K240744

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LLZ 2024-04-10

Neorad Pacs (Neorad Pacs)

Applicant Everrtech Software Pvt, Ltd.

K-Number K232641

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FYD 2024-04-10

8Q10 Surclear Smoke Plume Evacuation System

Applicant Surnic Corporation

K-Number K233789

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NGL 2024-04-10

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

Applicant Safecare Biotech (Hangzhou) Co., Ltd.

K-Number K240654

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MAX 2024-04-10

Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System

Applicant Zavation Medical Products, LLC

K-Number K233509

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DQD 2024-04-10

Keikku Electronic stethoscope

Applicant Lapsi Health Holding B.V.

K-Number K233313

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GEX 2024-04-10

NIRVANA

Applicant El.En S.P.A.

K-Number K234057

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OHS 2024-04-10

Face Patches (MT-12MA, MT-12MC)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K240089

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JAQ 2024-04-09

Universal Endometrial Applicator Set (GM11009840)

Applicant Varian Medical Systems, Inc.

K-Number K232623

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OOD 2024-04-09

GalaFLEX LITE Scaffold

Applicant Tepha, Inc.

K-Number K233999

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QHA 2024-04-09

CAAS Workstation

Applicant Pie Medical Imaging BV

K-Number K232147

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