16 results · 37ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Radiology

Oticon

FDA UDI
Oticon A/S·05707131322784·OPN 1, BTE 13 PP 2.4G 105 C090 DEMO

TRABIS [K173893]

FDA Adverse Event
Injury ·COLIGNE AG·Product code PLR·April 23, 2019

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

K SERIES CPAP SYSTEMS

FDA 510(k)
FDA Class 2 ·Anesthesiology

MIO ADVANCE

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code FPA·July 20, 2021

FORTIFY ASSURA VR, DF-4 CONNECTOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 15, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 24, 2011

IMF SCREW Ø2 L8 SST

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code DZL·June 17, 2013

RHYTHMIA HDX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025

APPROACH CTO MICROWIRE WIRE GUIDE

FDA Adverse Event
Injury ·Product code DQX·May 21, 2021

APPROACH CTO MICROWIRE WIRE GUIDE

FDA Adverse Event
Injury ·COOK INC·Product code DQX·December 28, 2021

APPROACH CTO MICROWIRE WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·October 17, 2023

APPROACH CTO MICROWIRE WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·October 3, 2023

APPROACH CTO MICROWIRE WIRE GUIDE

FDA Adverse Event
Injury ·COOK INC·Product code DQX·October 31, 2023

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·April 27, 2016