16 results · 21ms · Sources: EU EUDAMED, US FDA

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TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010

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

AETOS

FDA UDI
Smith & Nephew, Inc.·00885556920572·REVERSE INSTRUMENTS TRAY V2 BASE

Salem Sump Dual Lumen Stomach Tube with ENFit Connection

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

PARCUS GRAFT FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MENTOR MEMORYSHAPE BREAST IMPLANT

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FTR·October 9, 2024

GEENEN PANCREATIC STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·January 10, 2019

PULSE GEN MODEL 103

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·March 6, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MPRI·Product code LWS·August 8, 2014

MENTOR MEMORYGEL BREAST IMPLANT

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FTR·August 1, 2024

GEENEN PANCREATIC STENT

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

GEENEN PANCREATIC STENT

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

GEENEN PANCREATIC STENT

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

UNKNOWN

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·June 9, 2021

ZIMMON PANCREATIC STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·October 16, 2020

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021