9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
KWICK KOOLER
FDA 510(k)
FDA Class 1
·Physical Medicine
X-RAY COLLIMATOR
FDA 510(k)
FDA Class 1
·Dental
LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER
FDA 510(k)
FDA Class 2
·Physical Medicine
LOCKING SCREW, FULLY THREADED 4X28 MM
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HWC·January 4, 2007
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·December 12, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 6, 2014
KAPPA 900 DR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code DXY·October 15, 2012
SENSIA DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NVZ·August 10, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025