8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BreathID Hp System
FDA 510(k)
FDA Class 1
·Microbiology
ivi N3003 Surgical face Mask, ivi N6006 Surgical mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HSA-SOLUTION, MODEL 10034/10064
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TARGETING ARM PROX. LAT. TIBIA LEFT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·November 3, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 24, 2011
4000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 5, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025