7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PROPPER SUPER SERACULT(R)
FDA 510(k)
FDA Class 2
·Hematology
Finger Pulse Oximeter, Model: X1906P
FDA 510(k)
FDA Class 2
·Cardiovascular
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
FDA 510(k)
FDA Class 2
·Neurology
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·December 13, 2010
4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/40MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·January 18, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·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