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

NUH 2025-04-02

Progenix Select Stim

Applicant Progenix, LLC

K-Number K242460

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QKB 2025-04-01

MR Contour DL

Applicant GE Healthcare

K-Number K242925

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HSB 2025-04-01

Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur

Applicant OrthoPediatrics Corp.

K-Number K250623

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LZA 2025-04-01

Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)

Applicant Careglove Global Sdn. Bhd.

K-Number K250578

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EGJ 2025-04-01

STOPWET iontophoresis apparatus (SW01)

Applicant Taiwan Medical Electronics Co., Ltd.

K-Number K242041

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MOF 2025-04-01

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire

Applicant Scientia Vascular, Inc.

K-Number K243938

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NAY 2025-04-01

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)

Applicant Intuitive Surgical, Inc.

K-Number K242427

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HEB 2025-04-01

SABA Tampons

Applicant Essity Higiene Y Salud Mexico. S.A. DE C.V.

K-Number K242105

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GEX 2025-04-01

Medical Diode Laser Systems (THEIA808)

Applicant Gigaalaser Company , Ltd.

K-Number K250018

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NFO 2025-04-01

Préime DermaFacial (MicroT)

Applicant EMA Aesthetics , Ltd.

K-Number K243072

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GEX 2025-04-01

AdvaTx

Applicant Advalight Aps

K-Number K250189

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KDN 2025-03-31

Belzer UW® Cold Storage Solution (BTLBUW-001)

Applicant Bridge TO Life

K-Number K243384

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