14 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Jason membrane
FDA 510(k)
FDA Class 2
·Dental
Portex
FDA UDI
ICU MEDICAL, INC.·00351688056392·
MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
FDA 510(k)
FDA Class 1
·General Hospital
IntraNovo 25 Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ATTUNE PS RP INSRT SZ6 5MM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code NJL·January 16, 2025
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 10, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 12, 2015
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·November 11, 2014
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code NDJ·July 23, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 26, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 19, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 6, 2017
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025