14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010
TRANSEND GUIDEWIRE
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
TRANSEND GUIDEWIRE
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