FDA Device Intelligence
Home › Heidelberg Engineering GmbH › SPECTRALIS, HRT3, HEP

SPECTRALIS, HRT3, HEP

Heidelberg Engineering GmbH · Model HEYEX 2 SW V2.2 · UDI-DI 04059237000242

HPTMYCOBOMXK Prescription
10
510(k) clearances
3
Adverse events
1
Recalls
67
Facilities

Recalls

DateFirmReason
2012-08-17Haag-Streit USA IncThe firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.

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.