8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471121935·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 125mm
PEREGRINE 23GA CURVED LASER PROBE
FDA 510(k)
FDA Class 2
·Ophthalmic
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·December 27, 2012
ENRHYTHM DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·December 13, 2010
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 9, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021