7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-
FDA 510(k)
FDA Class 1
·Cardiovascular
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
FDA 510(k)
FDA Class 2
·Ophthalmic
PROFEMUR XM DISTAL CENTRALIZER
FDA 510(k)
FDA Class 2
·Orthopedic
AKREOS MICRO INCISION INTRAOCULAR LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·May 1, 2014
ASR ACETABULAR IMPLANT 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 13, 2012
4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·September 1, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025