14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FDR D-EVO GL Flat Panel Detector System
FDA 510(k)
FDA Class 2
·Radiology
Geneva
FDA UDI
Nucletron B.V.·08717213056350·Spreading Clip - Clip 1
Simpact Tri-Fin
FDA UDI
Life Spine, Inc.·00190837062910·8mm Tap, Cannulated
ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT
FDA 510(k)
FDA Class 2
·Dental
ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 26, 2024
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 7, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
MYNX
FDA Adverse Event
Malfunction
·ACCESS CLOSURE INC·Product code MGB·August 15, 2008
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·October 8, 2018
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 2016
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 5, 2024