17 results · 22ms · Sources: EU EUDAMED, US FDA

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T2 STRATOSPHERE™ Expandable Corpectomy System

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517578013·CoRoent Ant TLIF PEEK, 8x11x32mm 8°

TASMIN R 18°

FDA UDI
SIGNUS Medizintechnik GmbH·04047844015070·The basic shape of the TASMIN R devices is a ho...

PATHWAY PV ATHERECTOMY SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

ENSITE VELOCITY SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

CARTIVA IMPLANT

FDA Adverse Event
Injury ·CARTIVA, INC·Product code PNW·November 13, 2020

CARTIVA IMPLANT

FDA Adverse Event
Injury ·CARTIVA, INC·Product code PNW·November 9, 2020

MEDFUSION

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·January 4, 2023

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 17, 2014

EZ-PRO R4 AMBUL COT OBS(5/08)

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 21, 2013

EON MINI IPG, 16-CHANNEL RECHARGEABLE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 21, 2011

COREVALVE TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 22, 2018

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018