31 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm
FDA 510(k)
FDA Class 2
·Cardiovascular
HHM
FDA UDI
Oticon A/S·05707131283962·H100V2, MINIBTE 312 WL 85 TC HHM
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
INTRAVSCULAR ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 6, 2013
HIP HEAD,10/12 TAPER,28MM,+5MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 29, 2011
GE OEC 8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024
MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DTE·February 10, 2021
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·April 28, 2021
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 12, 2018
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 8, 2024
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 12, 2024
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018