8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMPTY DIALYSATE CONTAINER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
MRI MARKER
FDA 510(k)
FDA Class 2
·Radiology
DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 26, 2014
RESTORELLE DIRECT FIX POSTERIOR
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FTL·November 14, 2012
ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·September 12, 2007
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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025