14 results · 38ms · Sources: EU EUDAMED, US FDA

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REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH

FDA 510(k)
FDA Class 2 ·Dental

OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DIMENSION PENTA H, DIMENSION PENTA H QUICK

FDA 510(k)
FDA Class 2 ·Dental

PLATE BD CHROMAGAR O-157 20 EA

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code JSI·August 10, 2021

PLATE BD CHROMAGAR O-157 20 EA

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code JSI·August 10, 2021

CSF-FLOW CONTROL AVALVE, CONTOURED SMALL, HIGH PRESSURE

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·April 17, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 19, 2011

THERMACHOICE

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code MKN·July 2, 2008

2CM PERIPHERAL CUTTING BALLOON

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 4, 2019

2CM PERIPHERAL CUTTING BALLOON

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·October 7, 2019

2CM PERIPHERAL CUTTING BALLOON

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 19, 2019

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