9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Avanti Orthopaedics Ulnar Shortening System
FDA 510(k)
FDA Class 2
·Orthopedic
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022649·Dornier 600 µm Single-Use SMA Diode Laser Fiber...
YOULASER CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OXYGEN TREATMENT HOOD
FDA 510(k)
FDA Class 2
·Anesthesiology
ERBE VIO 300 D
FDA Adverse Event
Injury
·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·October 23, 2008
SYNCHRON LXI 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025