11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
FDA 510(k)
FDA Class 2
·General Hospital
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH
FDA Adverse Event
Malfunction
·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 21, 2019
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
NON STER XCOAT DELPH PUMP
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·October 3, 2014
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 7, 2013
CUSA NXT CONSOLE (115-230V)
FDA Adverse Event
Malfunction
·INTEGRA, TULLAMORE·Product code LFL·June 22, 2011
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023