15 results · 19ms · Sources: EU EUDAMED, US FDA

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TECHFIL

FDA 510(k)
FDA Class 2 ·Anesthesiology

ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE

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

MS-189 MUSCLE STIMULATOR

FDA 510(k)
FDA Class 2 ·Physical Medicine

GLIDEWIRE GT

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

SPRINT QUATTRO

FDA Adverse Event
Injury ·MPRI·Product code LWS·February 11, 2013

M2A-TAPER LINER SZ 41/32

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDL·July 24, 2014

UNIFY CRT-D, DF-4 CONNECTOR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011

GLIDEWIRE GT

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

CONSTELLATION SURGICAL PROCEDURE PACK

FDA Adverse Event
Malfunction ·ALCON RESEARCH, LLC - HOUSTON·Product code LRO·November 21, 2025

RADIFOCUS GLIDEWIRE

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

TERUMO RADIFOCUS GUIDE WIRE

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

GLIDEWIRE GT

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

ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

FDA Enforcement
Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Alcon Custom Pak

FDA Enforcement
Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023