16 results · 22ms · 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.

4CIS Marlin PEEK ACIF Cage

FDA 510(k)
FDA Class 2 ·Orthopedic

Bernafon

FDA UDI
Bernafon AG·05711584087183·ZR1, KIT 312 2.4G NFM 90 R BE ZERENA 1

ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE

FDA 510(k)
FDA Class 2 ·Physical Medicine

ELECSYS DIGOXIN CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PUSHING CATHETER

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·October 19, 2022

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 12, 2017

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 27, 2016

PUSHING CATHETER

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·September 15, 2023

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·March 10, 2017

PUSHING CATHETER

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FCG·June 28, 2023

FLEXOR RADIAL ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·March 10, 2017

PUSHING CATHETER

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2021

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems·October 10, 2018