16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EM Provisional
FDA 510(k)
FDA Class 2
·Dental
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551811·IN-OVATION® mini EURO 018/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551821·IN-OVATION® mini EURO 018/5-5 CBC HK
BD POSIFLUSH¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·January 31, 2018
BD POSIFLUSH¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·February 19, 2018
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
FDA 510(k)
FDA Class 2
·Radiology
DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
FDA 510(k)
FDA Class 2
·Orthopedic
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 26, 2013
ACCENT DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
CENTRA 850 BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 28, 2011
PANEL PHOENIX NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 4, 2024
PANEL PHOENIX NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 5, 2024
PANEL PHOENIX NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 5, 2024
PANEL PHOENIX NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 5, 2024
PANEL PHOENIX NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 12, 2024
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018