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