16 results · 26ms · Sources: EU EUDAMED, US FDA

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0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE

FDA 510(k)
FDA Class 2 ·Orthopedic

SANDMAN POCKET

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEPUY GLOBAL UNITE SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

1024879-2016-00054

FDA Adverse Event
Injury ·November 14, 2016

UNKNOWN PLATE

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

UNKNOWN PLATE

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

UNKNOWN PLATE

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code LJS·December 19, 2017

UNKNOWN IMPLANTABLE PUMP

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·October 10, 2014

HEARTSTART FRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 3, 2013

INTERSTIM

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·July 11, 2011

STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

FDA Adverse Event
Malfunction ·BIOMET MICROFIXATION·Product code HRS·January 10, 2019

CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Japan; 24 units per case

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt·Product code KDI·October 30, 2003

TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Injury ·COOK INC·Product code LJS·October 1, 2018

TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Injury ·COOK INC·Product code LJS·October 1, 2018

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024