15 results · 28ms · Sources: EU EUDAMED, US FDA

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Secret RF Smartcure Applicator with electrodes

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704513226·

ZEUS-L

FDA UDI
SPINAL ELEMENTS·00840916120696·ZEUS®-L 55 x 23 x 18mm 28 Degree

ZEUS-L

FDA UDI
SPINAL ELEMENTS·00840916120689·ZEUS®-L 55 x 23 x 18mm 14 Degree

ZIP'R MANTIS POWERED WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

VISIONSENSE STEREOSCOPIC VISION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024

R SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 10, 2013

DBS LEAD

FDA Adverse Event
Malfunction ·MPROC, VILLALBA·Product code MHY·July 11, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Death ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 17, 2014

MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·October 24, 2019

MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·January 10, 2020

CPX4 PLUS SMOOTH TALL HEIGHT 550CC

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·April 19, 2022

CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·February 22, 2021

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