11 results · 21ms · 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.

LATIS SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

NEUROTECH BAXOLVE TYPE 294

FDA 510(k)
FDA Class 2 ·Neurology

REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD PHASEAL¿ INJECTOR LUER LOCK N35C

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017

LIGACLIP** ENDOSCOPIC CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 22, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 27, 2014

PROTECTA XT CRT-D

FDA Adverse Event
Malfunction ·MEDTRONIC S.A.·Product code NIK·June 14, 2011

BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 18, 2021

BD PHASEAL¿ CONNECTOR LUER LOCK (C35)

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

FDA Enforcement
Class II ·Terminated·Isopure Corp·September 21, 2022

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025