13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Biodentine XP 500, Biodentine XP 200
FDA 510(k)
FDA Class 2
·Dental
NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EVERSTICKNET
FDA 510(k)
FDA Class 2
·Dental
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 29, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 8, 2013
STRATA®
FDA Adverse Event
Injury
·COVIDIEN LLC·Product code JXG·April 19, 2022
STRATA®
FDA Adverse Event
Death
·COVIDIEN LLC·Product code JXG·April 19, 2022
STRATA®
FDA Adverse Event
Malfunction
·COVIDIEN LLC·Product code JXG·April 19, 2022
STRATA®
FDA Adverse Event
Injury
·COVIDIEN LLC·Product code JXG·October 14, 2022
STRATA®
FDA Adverse Event
Death
·COVIDIEN LLC·Product code JXG·October 14, 2022
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021