12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
FDA 510(k)
FDA Class 2
·Neurology
AIACT KIT
FDA 510(k)
FDA Class 2
·Hematology
PRODESSE PROADENO
FDA 510(k)
FDA Class 2
·Microbiology
TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·January 8, 2013
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DYB·April 13, 2015
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWY·May 29, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·October 1, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 17, 2011
VITEK® 2 AST-YS08 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code NGZ·January 11, 2018
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·July 12, 2016
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024