49 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517289001·CoRoent® Large MP, 8x9x23 12°
IMRIS iMRI 3T V
FDA UDI
IMRIS Imaging, Inc.·00857534006745·IMRIS IMRI 3T V
InVision™ 3T Operating Suite
FDA UDI
IMRIS Imaging, Inc.·00857534006806·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450254615·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450255315·
8 x 23mm CitreLock Xpress Implant Kit
FDA UDI
Acuitive Technologies, Inc.·00810027270375·
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
FDA Enforcement
Class I
·Ongoing·IMPRIS Imaging Inc·November 5, 2025
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
FDA Enforcement
Class I
·Ongoing·IMPRIS Imaging Inc·November 5, 2025
ResQPUMP ACD-CPR Device
FDA UDI
Zoll Medical Corporation·00847946026950·RESQPUMP ACD-CPD DEVICE
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
FDA 510(k)
FDA Class 2
·Immunology
WOUND PRO APEX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·August 20, 2025
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 5, 2026
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 6, 2026
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 8, 2025
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 13, 2025
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·September 8, 2025
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 5, 2026
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·December 3, 2025