12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MolecuLight I:X
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GOMCO
FDA UDI
Allied Medical, LLC·00026072001707·ASPIRATOR, SURGICAL, STUD MNTD
CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROJET CRONO PAR AND CRONO APO-GO
FDA 510(k)
FDA Class 2
·General Hospital
GROSHONG 9.5 FR D/L CV CATHETER
FDA Adverse Event
Malfunction
·C. R. BARD, INC. (BASD)·Product code FOZ·March 26, 2009
VGXP XP E1 TIB BRG LL 12X79
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·March 24, 2022
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·October 28, 2008
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·August 4, 2011
ECHELON*FLEX60
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 9, 2013
VGXP INTLK FEMORAL LT 67.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·March 24, 2022
VGXP AS E1 TIB BRG LM/RL 14X79
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·March 24, 2022
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019