Home › IMEDICOM CO., LTD. › MEDINAUT-X(IBE System)

MEDINAUT-X(IBE System)

IMEDICOM CO., LTD. · Model IBE-15 · UDI-DI 08809317170367

NDN HRX Prescription

510(k) clearances

4,809

Adverse events (94 deaths)

Recalls

114

Facilities

Recalls

Date	Firm	Reason
2022-12-15	TEKNIMED SAS	Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
2021-05-18	Stryker Spine	The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
2021-05-18	Stryker Spine	The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized
2021-03-25	Zavation	Products distributed as sterile may not have been adequately sterilized

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 key Read 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.