15 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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TRIGLYCERIDES (GPO-TRINDER)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264742·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264704·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264759·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264735·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264711·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575264728·Modular Stem, Cylindrical Press-Fit, 6 mm Offset
KODAK EKTACHEM CLINICAL CHEM. SLIDES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HALOGEN EXAM. LITE #48400
FDA 510(k)
FDA Class 1
·General Hospital
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 27, 2014
CE INFUSOR, LV 5 ML/H,12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 25, 2010
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code IKX·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
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 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