FDA Device Intelligence
Home › ESU LIMITED LIABILITY PARTNERSHIP › ESU TRANSILLUMINATOR

ESU TRANSILLUMINATOR

ESU LIMITED LIABILITY PARTNERSHIP · Model MK-02GX · UDI-DI 00860003720509

HJN
3
510(k) clearances
24
Adverse events
1
Recalls
28
Facilities

Description

The device supports the identification of veins in neonates and infants for venipuncture through the use of an LED that emits a wavelength close to the "optical window," allowing for deeper light penetration into human tissue.

Recalls

DateFirmReason
2005-04-28Venoscope LLCExcessive heating due to incorrect wire assembly process.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.