13 results · 21ms · Sources: EU EUDAMED, US FDA

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PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

BioQuick®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609811·BioQuick-Brackets Roth .018" 20 Brackets 3-5 w....

GSA GENITO SENSORY ANALYZER

FDA 510(k)
FDA Class 1 ·Neurology

CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX

FDA 510(k)
FDA Class 2 ·Dental

BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·December 28, 2018

1.5MM MANDIBLE MESH FOOT C-TYPE FOR CMF DISTRACTOR

FDA Adverse Event
Injury ·SYNTHES USA·Product code MQN·April 16, 2013

840 VENTILATOR

FDA Adverse Event
Malfunction ·PURITAN BENNETT CORP.·Product code CBK·March 14, 2011

HYDROCOIL 14-SYSTEM COIL (HES)

FDA Adverse Event
Malfunction ·MICROVENTION, INC.·Product code HCG·June 12, 2008

HUIBREGTSE NEEDLE KNIFE PAPILLOTOME

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·July 19, 2022

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·March 21, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022