12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SurgiCount+ System
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517632005·CoRoent Ant TLIF Ti, 15x12x28mm 12°
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704284027·
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252282200·ceraMotion® Me Incisal Value 3, 20 g / dental c...
Cam Lock Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
VENAFLO II VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·February 19, 2025
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 14, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 17, 2011
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 29, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025