13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5
FDA 510(k)
FDA Class 2
·Orthopedic
BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE
FDA 510(k)
FDA Class 2
·General Hospital
ENDOLOGIX AFX INTRODUCER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
FUJIFILM DUODENOSCOPE MODEL ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·September 5, 2023
FUJIFILM ENDOSCOPE
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDS·March 18, 2022
FUJIFILM DUODENOSCOPE ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·March 5, 2025
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·June 6, 2013
INOMAX DS (DELIVERY SYSTEM)
FDA Adverse Event
Malfunction
·INO THERAPEUTICS, LLC/IKARIA·Product code MRP·April 5, 2011
REVEAL LINQ
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code DSI·October 10, 2014
HAMILTON-T1
FDA Adverse Event
Death
·HAMILTON MEDICAL AG·Product code CBK·September 12, 2024
BD¿ NEXIVA SINGLE PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 21, 2019
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021