11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PORTRAIT PSR3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DYNATRON STS RX
FDA 510(k)
FDA Class 2
·Neurology
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·November 5, 2019
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·April 16, 2013
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 14, 2011
BUTTONSWITCH PENCIL
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·June 13, 2008
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015