13 results · 20ms · Sources: EU EUDAMED, 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