9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RCT800
FDA 510(k)
FDA Class 2
·Radiology
OFFSET CUP REAMER HANDLE
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code OLO·June 23, 2016
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
FDA 510(k)
FDA Class 2
·Cardiovascular
EASYRA MG REAGENT, MODEL 10220
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URETEX SUP URETHERAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·April 26, 2013
ROTOPRONE THERAPY
FDA Adverse Event
Malfunction
·KCI USA, INC.·Product code IKZ·April 25, 2011
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 22, 2014
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026