7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
TIMLEINE(TM) VENIPUNCTURE SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
GORE BALLOON SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
CT Midline
FDA 510(k)
FDA Class 2
·General Hospital
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 12, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 12, 2012
OCTRODE PERCUTANEOUS 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