131 results
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22ms
·
Sources: EU EUDAMED, US FDA
PLEURA BIOPSY DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LAGUNA SIZE 8 PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·August 6, 2024
MICR GEMSTR CLV Y-SITE PE LNED ORNG 96IN
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 7, 2014
VIPER 2 5MM SELF DRILLING TAP, CANNULATED AND DUAL LEAD
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code LXH·January 8, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 12, 2010
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
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
INNER SHEATH, FOR 26 FR. OUTER SHEATH
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·June 16, 2023
RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HIH·January 20, 2026