16 results · 31ms · Sources: EU EUDAMED, US FDA

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SILC® Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

VARIOUS

FDA 510(k)
FDA Class 2 ·Orthopedic

SMITH & NEPHEW MIS HIP STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PREMICATH

FDA Adverse Event
Malfunction ·VYGON USA·Product code LJS·September 25, 2023

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026

EPIC PLUS DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

IVT DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code LHI·June 17, 2013

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 17, 2011

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025

FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·June 30, 2022

TERUMO RADIFOCUS GUIDE WIRE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025

FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·June 30, 2022

BLACK SILICONE FILIFORM DOUBLE PIGTAIL URETERAL STENT

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·January 31, 2023

FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·January 2, 2020

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018