29 results · 23ms · 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.

Brainsway Deep (DTMS) System

FDA 510(k)
FDA Class 2 ·Neurology

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169600102·TRIAL 2173540 O25 IB 20MM 18 DEG 16X40

CARDINAL HEALTH

FDA UDI
Cardinal Health 200, LLC·10887488481050·LP RADIOLOGY TRAY

PSORIA-LIGHT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

REFOBACIN BONE CEMENT R 1X40-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·March 30, 2026

REFOBACIN BONE CEMENT R 1X40-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·February 24, 2026

5.0MM TI W/ MAXBRAID NDLS

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code HWC·February 9, 2022

OPTIPAC 80 REFOB PLUS BONE CMT-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·March 17, 2026

ACCU-CHEK ® INFORM METER

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·June 17, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014

REFOBACIN BONE CEMENT R 2X40G

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code MBB·March 12, 2026

REFOBACIN BONE CEMENT R 2X20-3

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

REFOBACIN BONE CEMENT R 2X40G

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·February 20, 2026

OPTIPAC 80 REFOB BONE CMT R-3

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·November 14, 2025

Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

REFOBACIN BONE CEMENT R 1X40-3

FDA Adverse Event
Death ·BIOMET FRANCE S.A.R.L.·Product code MBB·December 15, 2025

REFOBACIN BONE CEMENT R 1X40-3

FDA Adverse Event
Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBB·December 30, 2024

REFOBACIN BONE CMNT R 1X40 JP

FDA Adverse Event
Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·May 7, 2025