Home › EON MEDITECH PRIVATE LIMITED › OSSEOUS Ear Specula
OSSEOUS Ear Specula
EON MEDITECH PRIVATE LIMITED · Model EI0954 · UDI-DI 08906039319545
EPY
Prescription
10
510(k) clearances
10
Adverse events
2
Recalls
231
Facilities
Description
"Ear Specula is a funnel shaped with oblique end which inserted into the auditory canal of the ear, allowing to look at the ear canal and ear drum. "
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
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 docsData 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.