28 results
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40ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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da Vinci Xi Surgical System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
PERFECT TISSUE CONTOURING SYSTEM II
FDA 510(k)
FDA Class 2
·Dental
METAFLEXCOIL
FDA 510(k)
FDA Class 2
·Radiology
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 8, 2020
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·July 1, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 26, 2022
UNKNOWN
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 24, 2022
BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 11, 2019
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·January 16, 2025
CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 14, 2014
RIA DRIVESHAFT L520
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·June 15, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·July 21, 2011
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 22, 2022
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 29, 2020
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 29, 2020
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 8, 2020
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 25, 2022
NASAL PANCREATIC DRAINAGE SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·June 9, 2021