8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TECA/MEDELEC MISTRAL
FDA 510(k)
FDA Class 2
·Neurology
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116
FDA 510(k)
FDA Class 2
·General Hospital
Vbeam Prima Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2024
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·May 27, 2014
AFX SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·December 19, 2012
TOTAL ASR ACET IMP SIZE
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 30, 2015
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025