FDA Device Intelligence
Home › INTEGRA MICROFRANCE › MicroFrance®

MicroFrance®

INTEGRA MICROFRANCE · Model MCO823 · UDI-DI 10381780104087

MXP Prescription
0
510(k) clearances
5
Adverse events
3
Recalls
18
Facilities

Description

MicroFrance® Temporal bone specimen holder

Recalls

DateFirmReason
2020-12-07Oto Med IncDuring internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
2020-12-07Oto Med IncDuring internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
2020-12-07Oto Med IncDuring internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

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.