18 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.

SPIROX INEX DEVICE

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003

FDA 510(k)
FDA Class 2 ·Cardiovascular

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 14, 2013

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 14, 2013

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 14, 2013

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 14, 2013

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 14, 2013

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 14, 2013

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 14, 2013

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 14, 2013

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 1, 2014

SHILEY XLT

FDA Adverse Event
Injury ·COVIDIEN·Product code JOH·May 23, 2013

ATTAIN OTW

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 17, 2011

Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 380 mm, Item Number: 814311380

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 19, 2018

E1 VNGD PS TIB BRG 79/83X12 OR

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 6, 2015

BD PHOENIX¿ NMIC-306

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 20, 2025

INTELLIS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 2, 2025