12 results · 21ms · Sources: EU EUDAMED, 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