14 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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THE STORZ BIPOLAR PENCIL AND CORD
FDA 510(k)
FDA Class 2
·Neurology
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533183·Articulating surface, vitamin E highly crosslin...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533176·Articulating surface, vitamin E highly crosslin...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533152·Articulating surface, vitamin E highly crosslin...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533190·Articulating surface, vitamin E highly crosslin...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533169·Articulating surface, vitamin E highly crosslin...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533206·Articulating surface, vitamin E highly crosslin...
ELECTROSURGICAL UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Retia 2
FDA 510(k)
FDA Class 2
·Ophthalmic
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 19, 2012
WECK HEMOCLIP SMALL
FDA Adverse Event
Injury
·TELEFLEX MEDICAL·Product code FZP·October 19, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 30, 2014
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017