7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37
FDA 510(k)
FDA Class 3
·Cardiovascular
3M Attest Rapid Readout Biological Indicator
FDA 510(k)
FDA Class 2
·General Hospital
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30
FDA 510(k)
FDA Class 2
·Anesthesiology
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 10, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 7, 2010
CAPNOSTREAM20
FDA Adverse Event
Malfunction
·ORIDION MEDICAL 1987 LTD.·Product code DQA·December 4, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021