17 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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Penumbra System (RED 68 Reperfusion Catheter)
FDA 510(k)
FDA Class 2
·Cardiovascular
Kompressor Compression Screw System
FDA UDI
Smith & Nephew, Inc.·00885556868973·K-WIRE, 1.1 MM X 6 IN (.045)
Kompressor™ Compression Screw System
FDA UDI
Ascension Orthopedics, Inc.·10381780280378·STANDARD K-WIRE 1.1MM
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551113423·HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 12...
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167322114110·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167312114110·
SELF-ADHESIVE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
FREEMIE (R)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014
NUFACE
FDA Adverse Event
Injury
·CAROL COLE COMPANY·Product code NFO·August 8, 2011
GYNECARE TVT OBTURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 8, 2013
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·June 11, 2024
ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
FDA Enforcement
Class II
·Terminated·Philips North America Llc·November 17, 2021
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020