21 results · 23ms · Sources: EU EUDAMED, US FDA

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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