18 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TRANSESOPHAGEAL ECHO TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL JY PACEMAKER LEAD - VARIOUS
FDA 510(k)
FDA Class 3
·Cardiovascular
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·April 20, 2015
AXIUM
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code HCG·March 27, 2023
PIPELINE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 27, 2023
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·April 20, 2015
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·April 21, 2015
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 19, 2014
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·October 22, 2010
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP.·Product code MKJ·November 15, 2012
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 4, 2024
MICRA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code DYB·February 20, 2025
MICRA
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code PNJ·February 20, 2025
MICRA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code PNJ·February 20, 2025
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026