12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JDICON ULTRA S
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 6, 2025
JDICON ULTRA S
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 6, 2025
JDEVOLUTION PLUS
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 6, 2025
ESA620 ELECTRICAL SAFETY ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
ATRICURE BIPOLAR COAGULATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PUMP MMT-715LNAP PRDGM INS V2.1 PL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·October 23, 2008
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·July 8, 2013
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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