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

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ONCOR EXPRESSION

FDA 510(k)
FDA Class 2 ·Radiology

Mini Mono®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70602261·Mini-Mono-Brackets 4th Dim. Ricketts 'S'.018" 2...

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K0602250·Tray, Base, 2.25"

VERDICT -II METHAMPHETAMINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR

FDA 510(k)
FDA Class 1 ·General Hospital

DESARA BLUE TV

FDA Adverse Event
Injury ·CALDERA MEDICAL INC.·Product code OTN·December 5, 2019

CONFIDA BRECKER CURVE GUIDEWIRE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DQX·June 5, 2025

PENTA

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 10, 2013

JOSTENT GRAFTMASTER

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MAF·April 15, 2011

ASP AUTOMATIC ENDOSCOPE REPROCESSOR

FDA Adverse Event
Injury ·ADVANCED STERILIZATION PRODUCTS·Product code FEB·June 12, 2008

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035; 4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040; 2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025; 3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030; 3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035; 4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040; 4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045; 5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050; 5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055

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