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