7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
TIMETER PRODUCED OHIO OXYGEN ADAPTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
OEC(R) 9800, OEC(R) 9800 PLUS
FDA 510(k)
FDA Class 2
·Radiology
SURE CHECK PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
TI OBA PLATE ANCHOR SCREW SELF-DRILLING 6MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code OAT·June 2, 2015
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