15 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.

5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)

FDA 510(k)
FDA Class 2 ·Radiology

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM

FDA 510(k)
FDA Class 1 ·Anesthesiology

AGILE ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

BD ULTRA FINE PEN NEEDLES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 27, 2020

AGILE ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

AGILE ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 20, 2025

AGILE ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

AGILE ESOPHAGEAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 30, 2025

PEN NDL 32GA 4MM 14BAG 700CASE JP

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·August 7, 2019

ANIMAS INSULIN CARTRIDGE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 5, 2011

OT VERIO IQ METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013

BD VACUTAINER® SST¿ II ADVANCE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 28, 2018

ACCOLADE DR SL MRI (Model L311)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025