17 results · 19ms · Sources: EU EUDAMED, US FDA

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CenterCross Ultra Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDTRONIC PS MEDICAL STRATA TYPE VALUE

FDA 510(k)
FDA Class 2 ·Neurology

ADVIA CHEMISTRY GLUH_3 REAGENTS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CONTOUR NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 22, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021

CONTOUR NEXT (CONNECTED)

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021

OSSIX BONE, OSSIX PLUS

FDA Adverse Event
Injury ·DATUM DENTAL LTD.·Product code NPM·June 22, 2022

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 10, 2013

WIRE COLLET

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·June 30, 2011

HS HAND CONTROLLED CURVED SHEA

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GEI·September 5, 2008

CONTOUR NEXT

FDA Adverse Event
Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021

CONTOUR NEXT (CONNECTED)

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020

MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 LM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·August 11, 2020

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021

CONTOUR NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 2, 2021

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