10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PVC Hydrophilic Urethral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Portex
FDA UDI
ICU MEDICAL, INC.·15019517076820·
RIVAL PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PCA-C1 series Patient Cable
FDA 510(k)
FDA Class 2
·Cardiovascular
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·August 14, 2024
ARTICUL/EZE BALL 28 +12 BLK
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code LPH·November 3, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 23, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020