8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
INJECTION NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL FORCE 2 ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 22, 2024
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 25, 2014
ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION
FDA Adverse Event
Death
·COOK, INC.·Product code MIH·November 9, 2010
FLOWTRON/UNIVERSAL PUMPS
FDA Adverse Event
Other
·GETINGE (SUZHOU) CO. LTD.·Product code JOW·November 30, 2012
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021