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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CREATININE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264773·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264766·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264810·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264797·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264803·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264780·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
DentiqGuide
FDA 510(k)
FDA Class 2
·Radiology
PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 27, 2014
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 25, 2010
PULSE GEN MODEL 102R
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·December 19, 2012
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. 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