7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
REDI-CHECK PHOTMETER Q.A.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LARGE TERRYCLOTH BIB
FDA 510(k)SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·January 22, 2013
AMS 700 INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FHW·December 10, 2010
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 9, 2014
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