13 results · 21ms · Sources: EU EUDAMED, US FDA

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VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Bard® Renal Sheath

FDA UDI
C. R. Bard, Inc.·00801741095023·Bard® Renal Sheath

QXLINK

FDA 510(k)
FDA Class 2 ·Radiology

SPECTRA CENTRAL PT MONITORING SYS

FDA 510(k)
FDA Class 2 ·Cardiovascular

BARD® RENAL SHEATH

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code LJE·June 28, 2023

RADIFOCUS OPTITORQUE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

PRIMEADVANCED

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 7, 2013

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

CAPSUREFIX MRI SURESCAN

FDA Adverse Event
Injury ·MPRI·Product code NVN·August 8, 2014

OPTITORQUE ANGIOGRAPHIC CATHETER

FDA Adverse Event
Malfunction ·Product code DQO·January 20, 2021

BARD® RENAL SHEATH

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code LJE·April 8, 2020

BARD® RENAL SHEATH

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code LJE·June 23, 2023

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012