17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATCH, PLEDGET AND INTRACARDIAC
FDA 510(k)
FDA Class 2
·Cardiovascular
Axiom® Dual-Sump
FDA UDI
AXIOM MEDICAL, INCORPORATED·M6651111870·Sump Drain, Three Lumens, Silicone, Small Eye, ...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390861786·
SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
FDA 510(k)
FDA Class 2
·General Hospital
FOUNDATION
FDA 510(k)
FDA Class 2
·Dental
CONTINUUM, TRILOGY IT, ALLOFIT IT, LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWZ·May 8, 2013
SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·May 26, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·December 30, 2011
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 30, 2011
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·December 30, 2011
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·December 30, 2011
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 30, 2011
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 7, 2021
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021