22 results · 24ms · 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.

LOGIQ S8

FDA 510(k)
FDA Class 2 ·Radiology

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169595828·TRIAL 2170445 O25 IB 20MM 0 DEG 14X45

ATRAMAT

FDA UDI
Internacional Farmacéutica, S.A. de C.V.·07500142068775·ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1...

FLEXFUSION (TM) FIXATION IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

KLASSIC HD HIP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MINIMAX STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025

MINIMAX RIGHT ANATOMICAL BROACH SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·February 20, 2020

MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2019

RESERVOIR 1.8ML

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 14, 2014

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·June 14, 2013

ECHELON*FLEX45 LONG

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 21, 2011

MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2017

LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 4, 2019

CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 4, 2019

CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 27, 2019

CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2021

ASAHI GLADIUS EX

FDA Adverse Event
Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025

ASAHI GLADIUS EX

FDA Adverse Event
Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 7, 2020

Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

FDA Enforcement
Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020