235 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STATClave G4 Chamber Autoclave
FDA 510(k)
FDA Class 2
·General Hospital
Sklar®
FDA UDI
SKLAR CORPORATION·10649111008214·BROWN TISSUE FCP 10"
FLUID-FILLED TEETHER
FDA 510(k)
FDA Class 2
·Dental
MODEL LUNA MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 10, 2025
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 11, 2025
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·July 25, 2011
HT70 VENTILATOR
FDA Adverse Event
Injury
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·June 25, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 11, 2026
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 7, 2026
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 3, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 5, 2025
INFUSOMAT®
FDA Adverse Event
Malfunction
·B.BRAUN MELSUNGEN AG·Product code FRN·April 30, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 13, 2026
PERFUSOR®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·April 14, 2026
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 19, 2025
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 1, 2025
INFUSOMAT®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FRN·May 11, 2026
Quanta System Sterile Optical Laser Fiber, reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021