29 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STAR Apollo Mapping System
FDA 510(k)
FDA Class 2
·Cardiovascular
Spud
FDA UDI
KATENA PRODUCTS, INC.·00841668101216·FRANCIS FOREIGN BODY SPUD
BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
FDA 510(k)
FDA Class 2
·Orthopedic
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CROSSTIE
FDA Adverse Event
Malfunction
·CROSSROADS EXTREMITY SYSTEMS·Product code HRS·September 29, 2022
5.5MM CANNULATED TAP
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code OLO·August 7, 2025
TRIMAX
FDA Adverse Event
Malfunction
·CROSSROADS EXTREMITY SYSTEMS·Product code JDR·September 29, 2022
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
4MM DIAMOND BALL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·June 4, 2024
SAMSUNG GALAXY WATCH 5 PRO (Z9NL)
FDA Adverse Event
Malfunction
·SAMSUNG ELECTRONICS AMERICA, INC.·Product code QDA·May 26, 2026
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·September 26, 2024
MICROPUNCTURE TRANSITIONLESS ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 30, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·December 6, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·November 5, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 26, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·November 13, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 31, 2024
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·December 6, 2024