17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Clip Flow
FDA 510(k)
FDA Class 2
·Dental
HEAD FIATION DEVICE (HFD 100)
FDA 510(k)
FDA Class 2
·Neurology
BERRY FRUITY TEETHER
FDA 510(k)
FDA Class 2
·Dental
S-ROM*SLEEVE PRX ZTT, 20D-SML
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 22, 2020
ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM
FDA Adverse Event
Injury
·LDR MEDICAL·Product code OVD·November 13, 2019
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014
CAPSUREFIX MRI
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 8, 2013
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·June 21, 2011
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·November 18, 2013
S-ROM*SLEEVE PRX ZTT, 20D-SML
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·November 18, 2013
PINN CAN BONE SCREW 6.5MMX30MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·November 18, 2013
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
ASAHI CONQUEST PRO 9-40
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021