29 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARESCAPE MONITOR B650
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517597212·CoRoent Large MP Ti, 12x9x23mm 12°
EVONOS GMBH & Co. Kg
FDA UDI
Gyrus ACMI, LLC·00821925012158·MALLEUS NIPPER ALLIGATOR FORCEPS
Oticon
FDA UDI
Oticon A/S·05707131255839·SENSEI, BTE 13 WL 90 PU
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
FDA 510(k)
FDA Class 2
·Ophthalmic
PROPHECY INFINITY
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·March 29, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
SPECTRIS SOLARIS SYRINGE KIT
FDA Adverse Event
Malfunction
·MEDRAD, INC.·Product code DXT·May 23, 2013
DA+ C SERIES DR
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 16, 2011
3004659744-2008-00015
FDA Adverse Event
Death
·Product code JAK·August 20, 2008
HEARTMATE II SYSTEM CONTROLLER, US, EP
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·June 13, 2022
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 8, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 19, 2023
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·January 16, 2019
Nerve Block Tray Catalog Number: 8415
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·May 28, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 15, 2025
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·December 2, 2022
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 22, 2024