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

DYG 2024-12-09

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)

Applicant Edwards Lifesciences

K-Number K242451

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OLV 2024-12-08

HomeSleepTest (HST, HST REM+)

Applicant Somnomedics GmbH

K-Number K240700

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QIH 2024-12-06

CDM Insights

Applicant Oxford Brain Diagnostics, Ltd.

K-Number K240680

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LNH 2024-12-06

SyMRI

Applicant Syntheticmr AB (Publ.)

K-Number K242524

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DQX 2024-12-06

PTFE Guidewire

Applicant Lake Region Medical

K-Number K242824

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LLZ 2024-12-06

PeekMed web

Applicant Peek Health, S.A.

K-Number K240926

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QIH 2024-12-06

DrAid™ for Liver Segmentation

Applicant Vinbrain Joint Stock Company

K-Number K241543

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FGE 2024-12-06

WallFlex Biliary PLUS RX Stent System

Applicant Boston Scientific

K-Number K242950

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OWB 2024-12-06

MC2 Portable X-ray System

Applicant Oxos Medical

K-Number K241567

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OLO 2024-12-06

AnyPlus Navigated Instruments System

Applicant GS Medical Co., Ltd.

K-Number K243073

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QAS 2024-12-06

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

Applicant Ever Fortune.Ai, Co., Ltd.

K-Number K241923

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OHT 2024-12-06

Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)

Applicant Shenzhen Jianchao Intelligent Technology Co., Ltd.

K-Number K242710

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