14 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DynaMatrix/Dynamatrix Plus
FDA 510(k)
FDA Class 2
·Dental
THREADED STEINMANN PINS, DOUBLE END TROCAR POINT
FDA UDI
Biomet Orthopedics, LLC·00887868016547·
RESTRAINTS
FDA Adverse Event
Malfunction
·DEROYAL·Product code FMQ·January 15, 2014
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIPER F2 FACET FIXATION SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·October 10, 2014
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·June 5, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·July 8, 2011
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·March 26, 2014
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
FDA Enforcement
Class II
·Terminated·Enztec Limited·February 3, 2021
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 13, 2026
Philips Zenition 70, Model Number: 718133
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024