9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
MEDTRONIC INPUT PS INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
WU'S 4-WHEELED SCOOTER, WT-L4JR
FDA 510(k)
FDA Class 2
·Physical Medicine
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·November 6, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 19, 2011
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 18, 2013
GEN II RESURF PATELLA 38MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 19, 2019
LEGION CR NP FEM SZ 8 RT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 18, 2019
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025