19 results · 24ms · Sources: EU EUDAMED, US FDA

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Zavation Cervical Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS

FDA 510(k)
FDA Class 2 ·Orthopedic

SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE

FDA 510(k)
FDA Class 2 ·General Hospital

QUADRA-P FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC

FDA Adverse Event
Injury ·COOK INC·Product code LJS·January 18, 2017

SCRDRIVERSHAFT T25 F/URS

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HXX·June 21, 2013

PROGRAMMING SOFTWARE

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·July 8, 2011

MBT REVISION CEM TIB TRAY S2.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·September 29, 2008

TURBO-JECT POWER INJECTABLE

FDA Adverse Event
Malfunction ·COOK INC·Product code LJS·July 3, 2018

VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 17, 2021

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2024

LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·January 13, 2023

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2025

TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

FDA Adverse Event
Malfunction ·COOK INC·Product code LJS·August 24, 2017

ELECSYS TSH ASSAY

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020

1820334-2020-01805

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·October 5, 2020

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 16, 2025

TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

FDA Adverse Event
Injury ·COOK INC·Product code LJS·June 28, 2018

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021