49 results · 29ms · Sources: EU EUDAMED, 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