21 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AUREFLO MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BioCare Safety Needles
FDA UDI
BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"
2560 4 WAY STOPCOCK
FDA UDI
HANS RUDOLPH, INC.·00874750009459·2560C 4W STPCK .187FB
HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP
FDA 510(k)
FDA Class 2
·Cardiovascular
CONCENTRIC BALLOON GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 17, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 21, 2025
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·June 2, 2025
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 27, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 10, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·November 17, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·August 6, 2025
CHARGER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·March 25, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
PLIVIOS 7MM PEEK-STERILE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MAX·April 29, 2011
LIGACLIP MCA LARGE APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDO·August 11, 2008
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·August 28, 2025
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·February 2, 2026
CHARGER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 26, 2025
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021