10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MICROMEDIC APS2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VENTURE™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074529721·4.0 X 14 SELF DRILL VAR SCREW
SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET
FDA 510(k)
FDA Class 2
·General Hospital
CivaDerm
FDA 510(k)
FDA Class 2
·Radiology
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIU·November 19, 2015
ALLOCLASSIC SL STEM 1 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·April 26, 2018
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 5, 2014
MAXIMO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 15, 2012
MARQUIS SERIES STOPCOCKS
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·August 6, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025