9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge
FDA 510(k)
FDA Class 1
·Dental
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022441·600 micron core/730 micron OD Luer Lock Diode L...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102848·FUKASAKU SMALL PUPIL SNAPPER HOOK
CERCOM II CEMENT
FDA 510(k)
FDA Class 2
·Dental
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
FDA 510(k)
FDA Class 2
·General Hospital
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·November 6, 2014
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·August 18, 2011
PULSE GEN MODEL 102
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 18, 2013
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 26, 2019