29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CS 8100 3D
FDA 510(k)
FDA Class 2
·Radiology
HHM
FDA UDI
Oticon A/S·05707131262097·H110, RITE 312 WL SIL HHM
DreamWear Full
FDA UDI
Respironics, Inc.·00606959045927·DreamWear Full Mask, M, w/M Frame w/o Headgear,...
WESTCOTT TENOTOMY SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896014572·WESTCOTT TENOTOMY SCISSORS CURVED BLUNT BLADE S...
SMALL BONE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 16, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 16, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·October 22, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·February 12, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
M2A MAGNUM MODULAR HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·June 14, 2011
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 22, 2008
CARDIOCHEK PLUS ANALYZERQ
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·August 18, 2022
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·July 28, 2023
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·May 24, 2024
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·January 6, 2023
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·January 11, 2024
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·November 21, 2023
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 14, 2024