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

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VINYL EXAMINATION POWDER FREE GLOVES, CLEAR

FDA 510(k)
FDA Class 1 ·General Hospital

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011123590000·Super hard metal burs, with cross toothing cut,...

DILATOR TUBE SET

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

ID NOW COVID-19

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 18, 2020

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·May 17, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 26, 2014

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 1, 2020

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

GLIDEWIRE ADVANTAGE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 9, 2025

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 23, 2022

CAPIOX RX OXYGENATOR

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 28, 2019

TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

FDA Adverse Event
Malfunction ·CODMAN AND SHURTLEFF, INC·Product code HCG·June 15, 2017

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 3, 2025

RADIFOCUS GUIDEWIRE ADVANTAGE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 12, 2024

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·August 7, 2020

RADIFOCUS GUIDEWIRE M

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·September 23, 2020