11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex FiberTape and TigerTape Cerclage Sutures
FDA 510(k)
FDA Class 2
·Orthopedic
HQ-Chex
FDA UDI
STRECK, INC.·20844509001694·A whole blood glucose and hemoglobin control de...
NEUROMATE FRAMELESS GEN II
FDA 510(k)
FDA Class 2
·Neurology
MODEL 509M PULSE OXIMETER, MODEL 509M
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·March 24, 2020
MOSAIC
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 11, 2025
HEARTSTRING III PROXIMAL SEAL SYSTEM
FDA Adverse Event
Malfunction
·GUIDANT CARDIAC SURGERY·Product code DXC·November 14, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 2, 2011
PHOENIX
FDA Adverse Event
Injury
·GAMBRO DASCO S.P.A·Product code KDI·July 18, 2013
BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·April 4, 2022
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025