136 results · 29ms · Sources: EU EUDAMED, US FDA

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AcuityUDR

FDA 510(k)
FDA Class 2 ·Radiology

COMPREHENSIVE NEUROMUSCULAR PROFILER

FDA 510(k)
FDA Class 2 ·Physical Medicine

CUBEScan BioCon-1100

FDA 510(k)
FDA Class 2 ·Radiology

HILL-ROM

FDA Adverse Event
Other ·HILL-ROM·Product code FNL·February 2, 1998

REFLEX

FDA Adverse Event
Death ·TELECTRONICS PACING SYSTEMS INC·Product code DXY·February 6, 1998

INNER SHEATH, FOR 26 FR. OUTER SHEATH

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 6, 2024

ARROW INTERVENTIONAL PSI SET

FDA Adverse Event
Injury ·ARROW INTL., INC.·Product code DYB·May 12, 1998

UNK

FDA Adverse Event
Injury ·UNK·Product code CAZ·December 19, 1997

IMMAGE IMMUNOCHEMISTRY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JQX·September 1, 2011

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

CONMED 5MM AUTOMATIC CLIP APPLIER

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code FZP·July 15, 2013

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

GEL FILLED MAMMARY IMPLANT

FDA Adverse Event
Injury ·DOW CORNING CORP·Product code FTR·October 16, 1996

PADGETT ELECTRO-DERMATOME MODEL B 110 V

FDA Adverse Event
Malfunction ·INTEGRA LIFESCIENCES CORPORATION·Product code GFD·January 19, 2006

INNER SHEATH, FOR 26 FR. OUTER SHEATH

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 18, 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