148 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICAL TROCAR AND CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)
FDA 510(k)
FDA Class 2
·Dental
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO
FDA 510(k)
FDA Class 2
·Cardiovascular
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 6, 2024
ACTICON NEOSPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·December 10, 2010
PHOENIX DISPOSABLE PRESSURE TRANSDUCER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·July 14, 2014
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·December 31, 2012
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·February 15, 2023
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·March 14, 2023
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 18, 2025
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·December 11, 2025
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 19, 2025
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 19, 2025
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 19, 2025
RESECTION SHEATH, 24 FR.
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 27, 2025
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·October 19, 2025
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 25, 2025
RESECTION SHEATH, 24 FR.
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·April 14, 2023
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 8, 2024
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·July 29, 2025