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

QIH 2025-02-28

Myomics

Applicant Phantomics, Inc.

K-Number K241922

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PHR 2025-02-28

Silver Fluoride Hypersensitivity Varnish

Applicant Young Dental Manufacturing Co. 1, LLC

K-Number K241041

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MOL 2025-02-28

Durex Polyisoprene Condom

Applicant Rb Health (Us), LLC

K-Number K241617

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PCH 2025-02-28

QIAstat-Dx GI Panel 2 Mini B

Applicant QIAGEN GmbH

K-Number K250324

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BZQ 2025-02-28

Airmod

Applicant Heroic Faith International , Ltd.

K-Number K242798

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PSY 2025-02-28

E1000 Dx Digital Pathology Solution

Applicant Shandon Diagnostics Limited

K-Number K241717

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POL 2025-02-28

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device

Applicant Phenox Limited

K-Number K242676

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DQY 2025-02-28

Seclusion Catheter

Applicant Basis Medical

K-Number K243436

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KDI 2025-02-28

FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K243874

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DQA 2025-02-28

Pulse Oximeter ( PO2, PO2A, PO2B)

Applicant Shenzhen Viatom Technology Co., Ltd.

K-Number K242876

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OZN 2025-02-28

Xpert C. difficile/Epi

Applicant Cepheid®

K-Number K243730

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EFB 2025-02-28

Synea Fusion Handpieces (Intensiv & Profin)

Applicant W&H Dentalwerk Bürmoos GmbH

K-Number K242179

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