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

GEX 2024-08-12

Eneka Selectif

Applicant Termosalud

K-Number K241656

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NUH 2024-08-12

Pixie Pulse (SM9068)

Applicant Pixie Cup, LLC

K-Number K241365

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QIH 2024-08-12

OptimMRI (v2)

Applicant Rebrain, Sas

K-Number K242054

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CHH 2024-08-09

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES

Applicant Medicon Hellas S.A

K-Number K232404

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DQK 2024-08-09

EnSite™ X EP System

Applicant ABBOTT MEDICAL

K-Number K242016

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ITI 2024-08-09

Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)

Applicant Suzhou Ideal Medical Co., Ltd.

K-Number K240079

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CBP 2024-08-09

F&P Optiflow Flow Diverter

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K234053

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IYN 2024-08-09

SonoMax Series Digital Color Doppler Ultrasound System

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K233697

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MNT 2024-08-09

F&P Airvo 3 NIV (PT311US)

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K233643

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KNW 2024-08-09

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

Applicant SurGenTec, LLC

K-Number K240664

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GEX 2024-08-09

MEDIDIODE

Applicant Medicreations, LLC

K-Number K231950

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EKX 2024-08-09

The Trust

Applicant Genoss Co., Ltd.

K-Number K222688

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