7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ACCULITE SSL
FDA 510(k)
FDA Class 1
·Radiology
INTRABLOCK BIOBALL HIP SYSTEM (IBS)
FDA 510(k)
FDA Class 2
·Orthopedic
PLASTIC ELASTOMER ENCASED IN TERRY CLOTH
FDA 510(k)
FDA Class 1
·Physical Medicine
PINNACLE SECTOR II CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·December 9, 2010
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013
PROMUS ELEMENT? PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·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