7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ACA DATA MATE ACCESSORY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Cranial COVER
FDA 510(k)
FDA Class 2
·Neurology
MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
FDA 510(k)
FDA Class 2
·Anesthesiology
INTERPULSE HANDPIECE WITH COAXIAL FAN SPRAY TIP
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code FQH·April 21, 2014
LCP DRILL BIT 2.8 W/STOP L165 2FLUTE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTW·September 20, 2012
CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 19, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025