7 results
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19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
EDM(R) INFUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
AVI MODEL 600 SYRINGE PUMP, MODIFICATION
FDA 510(k)
FDA Class 2
·General Hospital
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 15, 2013
UNKNOWN DEPUY PINNACLE METAL LINER
FDA Adverse Event
Injury
·DEPUY INTL., LTD.8010379·Product code KWA·July 29, 2014
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021