9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CT Lung Ventilation Analysis Software (CT:V)
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102831·FUKASAKU SNAPPER HOOK
MORALES PROTRACTION FACEMASK
FDA 510(k)
FDA Class 2
·Dental
SIR-Spheres Microspheres Activity Calculator (SMAC)
FDA 510(k)
FDA Class 2
·Radiology
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 18, 2011
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·November 6, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025