17 results · 22ms · Sources: EU EUDAMED, US FDA

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Portable Mesh Nebulizer

FDA 510(k)
FDA Class 2 ·Anesthesiology

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025

UNITY BETA ANCHOR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025

GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 11, 2019

PRUITT F3 CAROTID SHUNT

FDA Adverse Event
Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

COBAS 6000 C501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 21, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 17, 2014

PRUITT F3 CAROTID SHUNT

FDA Adverse Event
Injury ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

PRUITT F3 CAROTID SHUNT

FDA Adverse Event
Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023

PRUITT F3 CAROTID SHUNT

FDA Adverse Event
Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025

BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

FDA Enforcement
Class II ·Terminated·Biomet 3i, LLC·January 13, 2016