7 results
·
35ms
·
Sources: EU EUDAMED, US FDA
HORIZONTAL NEEDLE GUIDE ATTACHMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PROLONGED OCCLUSION DRESSING I
FDA 510(k)
FDA Unclassified
·Unknown
RIONET HEARING AID HB-71K (K-AMP)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
GENESYS HTA PROCERVA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code MNB·July 20, 2015
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·November 8, 2010
TENDRIL SDX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024