14 results · 21ms · Sources: EU EUDAMED, US FDA

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MODEL 5135 AUTO LP/FLASH

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TRANSEND EX 14 GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION·Product code DQX·September 23, 2009

SEHRIST VOLUME VENTILATOR, MODEL 2200B

FDA 510(k)
FDA Class 2 ·Anesthesiology

ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

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FDA Adverse Event
Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009

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FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010

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FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

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FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010

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FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

PROGRASP (TM) FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·February 5, 2013

AVANTA

FDA Adverse Event
Malfunction ·MEDRAD, INC.·Product code DXT·December 14, 2010

MPS2

FDA Adverse Event
Injury ·QUEST MEDICAL INC·Product code DTR·July 14, 2014

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FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025