148 results · 23ms · Sources: EU EUDAMED, 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