21 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM
FDA Adverse Event
Injury
·LDR MEDICAL·Product code OVD·November 13, 2019
ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·April 23, 2019
ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·January 27, 2023
ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·May 13, 2023
BINAXNOW COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 1, 2021
BINAXNOW¿ COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 5, 2021
BINAX NOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 19, 2021
BINAXNOW¿ COVID-19 ANTIGEN SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·August 15, 2021
ASICO SOFTIP INJECTOR SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
EQUIPMENT SLUSH DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BINAX NOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 26, 2021
BINAX NOW COVID-19 AG CARD
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 31, 2021
BINAXNOW COVID-19 AG SELF TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 27, 2021
FORTIFY DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014
CAPSURE SP 4024
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
HUT EXT DR FINAL ASSY-REVERSE
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·June 21, 2011
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Injury
·CONMED UTICA·Product code GEI·May 18, 2023
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·May 25, 2023
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023