10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MILLONIGS MODIFIED PHOSPHATE BUFFERED
FDA 510(k)
FDA Class 1
·Pathology
LEONE SPA
FDA UDI
LEONE SPA·08033707028925·WEB 1ST MOLAR BANDS n.UL 14
Hi-Pull
FDA UDI
LANCER ORTHODONTICS, INC.·00817573024094·HI-PULL STRAP BLUE MEDIUM 5/PK
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·December 8, 2025
FREESTYLE LITE
FDA Adverse Event
Injury
·Product code NBW·May 23, 2014
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 10, 2012
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEM INC.·Product code LZG·September 2, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018