24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REDUCT® Headless Compression Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023288·270 Micron SU Thulio Performance 3m Fiber
NA
FDA UDI
Synthes GmbH·10886982142313·2.4MM CORTEX SCREW SELF-TAPPING 32MM
ARCHITECT C16000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·February 2, 2018
ARCHITECT C16000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES (IRVING IA/CC)·Product code JJE·August 23, 2020
MAGLY 6.5MM CANNULATED SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
CHASE CARDIOVASCULAR PATCH
FDA 510(k)
FDA Class 2
·Cardiovascular
ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·June 27, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014
NEXGEN STEMMED TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·June 28, 2013
DA+ T SERIES DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·August 11, 2011
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·December 29, 2016
ROSEN AMPLATZ EXTRA STIFF WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·May 13, 2019
HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·August 14, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·August 14, 2018
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 30, 2026
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024
ON-X AORTIC VALVE
FDA Adverse Event
Injury
·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·July 14, 2017
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021