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 2025-06-10

Viz Subdural+, Viz SUBDURAL PLUS

Applicant Viz. Ai, Inc.

K-Number K250354

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QVP 2025-06-10

Elecsys Anti-SARS-CoV-2

Applicant Roche Diagnostics

K-Number K250768

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FRO 2025-06-09

Bonvadis®

Applicant Oneness Biotech Co., Ltd.

K-Number K251093

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QOG 2025-06-09

MallyaG Injection Pen Adapter (MallyaG)

Applicant Biocorp Production

K-Number K251500

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OHS 2025-06-09

LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

Applicant Shenzhen Sungrow Led Technology Co., Ltd.

K-Number K250830

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GEX 2025-06-09

CO2 Laser Machine (Lume)

Applicant Nanjing Bestview Laser S&T Co., Ltd.

K-Number K250465

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PNL 2025-06-07

Magnetic Surgical System

Applicant Levita Magnetics International Corp

K-Number K250746

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QNM 2025-06-06

Anovo Surgical System (6Ne)

Applicant Momentis Surgical , Ltd.

K-Number K250591

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FRG 2025-06-06

GCI Sterilization Wrappers

Applicant George Courey, Inc.

K-Number K250321

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QIH 2025-06-06

Cirrus Resting State fMRI Software

Applicant Sora Neuroscience, Inc.

K-Number K251009

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BTA 2025-06-06

Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)

Applicant Shenzhen Desida Technology Co., Ltd.

K-Number K251450

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EBF 2025-06-06

Once-Fil Flow

Applicant Mediclus Co., Ltd.

K-Number K251283

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