28 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO: SECTRA IDS5 WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
PYRAMESH® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490484497·MESH 9051315 PYRM IMPLANT 13MMX15MM RND
PYRAMESH® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000855666·MESH 9051315 PYRM IMPLANT 13MMX15MM RND
DETACHOL
FDA UDI
FERNDALE LABORATORIES, INC.·00304960513151·ADHESIVE REMOVER
FIX-C PEEK ACIF SA System
FDA UDI
Jeil Medical Corporation·08800089475704·
FIX-C PEEK ACIF SA System
FDA UDI
Jeil Medical Corporation·08800089475728·
FIX-C PEEK ACIF SA System
FDA UDI
Jeil Medical Corporation·08800089475759·
FIX-C PEEK ACIF SA System
FDA UDI
Jeil Medical Corporation·08800089475735·
FIX-C PEEK ACIF SA System
FDA UDI
Jeil Medical Corporation·08800089475766·
FIX-C PEEK ACIF SA System
FDA UDI
Jeil Medical Corporation·08800089475773·
FIX-C PEEK ACIF SA System
FDA UDI
Jeil Medical Corporation·08800089475742·
FIX-C PEEK ACIF SA System
FDA UDI
Jeil Medical Corporation·08800089475711·
MODIFICATION TO KION ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
FDA 510(k)
FDA Class 2
·Radiology
EXPECT PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·May 19, 2026
EXPECT PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·September 24, 2025
ACQUIRE? PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·October 10, 2025
EXPECT PULMONARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·November 14, 2024
CELL-DYN DILUENT/SHEATH
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007
EXPECT PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·April 14, 2026