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

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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KRH 2024-04-09

TransForm McCarthy Mitral Annuloplasty Ring (TF)

Applicant Genesee Biomedical, Inc.

K-Number K232599

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GCJ 2024-04-09

Disposable Trocars

Applicant Hangzhou Kangji Medical Instrument Co., Ltd.

K-Number K233263

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SAO 2024-04-09

Rho

Applicant 16 Bit, Inc.

K-Number DEN230023

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QBD 2024-04-08

Sample preservation solution

Applicant Zhejiang Gene Science Co., Ltd.

K-Number K212878

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