7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
PROSTHESIS WIRE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PSI BANDS
FDA 510(k)
FDA Unclassified
·Unknown
REGULATOR, PRESSURE, EXPIRATORY
FDA 510(k)
FDA Class 2
·Anesthesiology
ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·June 12, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·December 12, 2012
LAMITRODE TRIPOLE 16C LEAD
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·September 29, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022