9 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LINQ II Insertable Cardiac Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05714464008575·AGXO F300 MINIRITE R C090
PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
FDA 510(k)
FDA Class 2
·Cardiovascular
OLYMPUS ULTRASONIC SURGICAL SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·November 3, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·August 17, 2011
SPECTRUM WIRELESS BATTERY MODULE G
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·July 5, 2013
GARRETT-OSSOFF-PILLING LARYN 25MM X 19CM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAL·September 13, 2017
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025