16 results · 21ms · Sources: EU EUDAMED, US FDA

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Zimmer Persona Personalized Knee System

FDA 510(k)
FDA Class 2 ·Orthopedic

VANGUARD ROCC POR FEM S60 L

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·February 3, 2026

VANGUARD MONO FINNED STM TIB 71X8

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·August 9, 2023

VANGUARD ROCC POR FEM S60 L

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025

LVIS Junior

FDA UDI
Microvention, Inc.·00811425029909·Low-Profile Visualized Intraluminal Support

LVIS Jr.

FDA UDI
Microvention, Inc.·00810170014437·Stent

LVIS Jr.

FDA UDI
Microvention, Inc.·00842429100844·Stent

BD NOKOR¿ FILTER NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·August 9, 2023

BD NOKOR¿ FILTER NEEDLE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·August 9, 2023

FUTURA

FDA 510(k)
FDA Class 2 ·Physical Medicine

HAIRMAX LASERCOMB

FDA 510(k)
FDA Class 2 ·Physical Medicine

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 7, 2021

PINN SECTOR HA ACET CUP 50MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·June 17, 2013

UNICEL DXC 800 SYNCHRON SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011

MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·September 23, 2008

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