10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
NORLAND MODEL 278 BONE DENSITOMETER
FDA 510(k)
FDA Class 2
·Radiology
ELECATH MULTI-PURPOSE ARTERIAL SURGER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
mCare® Powder Free Nitrile Black Examination Glove
FDA 510(k)
FDA Class 1
·General Hospital
MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH
FDA Adverse Event
Malfunction
·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023
CERTAIN¿ TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·July 27, 2023
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 6, 2014
COBAS INTEGRA 400 PLUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CGZ·October 16, 2012
MARQUIS DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2010
CERTAIN¿ TITANIUM LARGE HEXED SCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·July 27, 2023
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025