12 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
iTEAR100 Neurostimulator
FDA 510(k)
FDA Class 2
·Ophthalmic
CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
2250051-2008-00391
FDA Adverse Event
Malfunction
·Product code JTC·August 1, 2008
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 23, 2024
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·June 7, 2023
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·June 8, 2023
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025