7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1
FDA 510(k)
FDA Class 2
·Radiology
Cefaly Acute
FDA 510(k)
FDA Class 2
·Neurology
ELECTRODE ARRAY CAP
FDA 510(k)
FDA Class 2
·Neurology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 29, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 5, 2012
ECMO 1500
FDA Adverse Event
Malfunction
·MEDTRONIC INC.·Product code DTZ·September 27, 2010
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026