13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BAUSCH & LOMB WETTING AND SOAKING SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
DeltaForm HD
FDA UDI
Merz Dental GmbH·D7091980133·DeltaForm HD lower posteriors, L, D2 -MADE IN G...
P.F.C.
FDA UDI
DEPUY (IRELAND)·10603295251729·P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS O...
NA
FDA UDI
Zimmer, Inc.·00889024156692·
WALLSTENT ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·January 15, 2025
MOUNTABLE ENDOSCOPIC BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MUSCLE STIMULATOR, ELECTRICAL
FDA 510(k)
FDA Class 2
·Physical Medicine
WALLSTENT ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 22, 2025
WALLSTENT ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 1, 2025
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 25, 2014
GREENLIGHT HPS BPH FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·February 21, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD.·Product code JAA·January 24, 2011
Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number SAN73CCV12; 5) Cardiac Catheterization Kit, Catalog Number SAN73CCV13; 6) Cardiac Catheterization Kit, Catalog Number SAN73CCV14; 8) Cardiac Catheterization Kit, Catalog Number SAN73CCVD8; 9) Cardiac Catheterization Kit, Catalog Number SAN73CCVD9; 10) Cardiac Catheterization Kit, Catalog Number SAN73CCVDG; 11) Cardiac Catheterization Kit, Catalog Number SAN73CCVDH; 12) Cardiac Catheterization Kit, Catalog Number SAN73CCVDI
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·July 17, 2024