7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
RESPONSE SYSTEM, TN-3000
FDA 510(k)
FDA Class 2
·Neurology
Blood Transfer Accessory (BTA)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
FDA 510(k)
FDA Class 2
·Anesthesiology
PROMOTE PLUS CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·April 30, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 11, 2012
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 19, 2015
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025