10,000 results · 54ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Passing wire Ø2.4 L380

Device
EU MDD · Eu Md Class 2a ·Medacta International SA·On the market·32 countries

K-wire Ø2.4 L380

Device
EU MDD · Eu Md Class 2a ·Medacta International SA·On the market·32 countries

Drill Ø2.4 - Long

Device
EU MDD · Eu Md Class 2a ·Medacta International SA·On the market·32 countries

OPTIPAC 60 REFOB BONE CMT R-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·May 11, 2026

QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 5, 2016

Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.

FDA Recall
Terminated ·Medacta Usa Inc·Product code KWP·December 7, 2016

FLEXIBLE AO BAYONET SHAFT Ø 6.5 L 135

FDA Adverse Event
Malfunction ·GREATBATCH MEDICAL·Product code LXH·April 24, 2019

GMK-HINGE FEMORAL COMPONENT SIZE 6 RIGHT

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code KRO·August 18, 2017

QUADRA S FEMORAL STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·January 14, 2011

Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.

FDA Enforcement
Class II ·Terminated·Medacta Usa Inc·January 25, 2017

MPACT ACETABULAR SHELL Ø50 MULTI-HOLE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LPH·July 21, 2017

AMISTEM H STEM SIZE 4 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 29, 2016

LOCKING TOWER ENHANCED

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·July 12, 2017

FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·September 30, 2016

HIP GENERAL, OFFSET - 30° BROACH HANDLE - RIGHT

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·February 17, 2016

Passing wire Ø2.4 L380

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Medacta International SA·1 device

K-wire Ø2.4 L380

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Medacta International SA·1 device

Drill Ø2.4 - Long

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Medacta International SA·1 device

UNK - NAIL HEAD ELEMENTS: SCREW

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code HSB·July 31, 2025

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX 3/10 MM RIGHT

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·February 25, 2016