7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PATIENT GUIDED ELBOW & SHOULDER EXERC
FDA 510(k)
FDA Class 1
·Physical Medicine
NEWA SKIN THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMPLANTABLE PROGRAM. CARDIAC PACEMAKER
FDA 510(k)
FDA Class 3
·Cardiovascular
PENUMBRA ASPIRATION PUMP CANISTER
FDA Adverse Event
Malfunction
·PENUMBRA INC.·Product code BTA·March 15, 2010
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 23, 2014
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 13, 2012
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026