9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BOWEN CANNULA
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Zenysis Dual Lumen Acute Dialysis Catheter
FDA UDI
Bard Access Systems, Inc.·00801741109775·Zenysis DL, 15cm PC Kit
Power-Trialysis Slim-Cath catheter
FDA UDI
Bard Access Systems, Inc.·00801741107283·12Fr Trialysis PC 15cm Kit
ViMove2
FDA 510(k)
FDA Class 2
·Physical Medicine
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
FDA 510(k)
FDA Class 2
·Immunology
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2014
CAPSUREFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 10, 2012
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