17 results · 20ms · Sources: EU EUDAMED, US FDA

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Telescope Guide Extension Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

MobileLink Acetabular Cup System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575177677·UHMWPE Inserts -X-LINKed; Standard (Neutral)

MobileLink Acetabular Cup System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575177684·UHMWPE Inserts -X-LINKed; Standard (Neutral)

MobileLink Acetabular Cup System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575177660·UHMWPE Inserts -X-LINKed; Standard (Neutral)

MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CAPSURE(R) PS SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DISCOVERY MR450

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code LNH·April 4, 2012

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EZL·December 6, 2021

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
CONSMA·Product code ITJ·June 21, 2013

CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·July 28, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014

Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·April 24, 2019

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EYB·July 2, 2024

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EZL·February 28, 2022

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Injury ·COOK INC·Product code EZL·July 8, 2022

UPJ OCCLUSION BALLOON CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code EZL·January 15, 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