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

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INTENSE PULSED LIGHT (IPL) SYSTEMS

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

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970560·

TALON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

COLLATEK HYDROGEL

FDA 510(k)
FDA Unclassified ·Unknown

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·October 21, 2020

PULSE GEN MODEL UNK

FDA Adverse Event
Injury ·CYBERONICS·Product code LYJ·May 21, 2013

RESERVOIR 1.8ML

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code FRN·September 26, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code KDJ·June 14, 2011

BD BACTEC¿ MGIT¿ 960 PZA KIT

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·July 23, 2025

BD BACTEC¿ MGIT¿ 960 PZA KIT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·October 30, 2023

SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·February 11, 2021

SAF-T-INTIMA W/Y ADAPTER GN 18GA X 1.0IN

FDA Adverse Event
Injury ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 13, 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