14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HOWMEDICA OSTEONICS FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
artegral life
FDA UDI
Merz Dental GmbH·D7091993601·anteriors; shade BL3; mould BOL
Galaxy Fixation System
FDA UDI
ORTHOFIX SRL·18054242511656·Galaxy Wrist Sterile Kit
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code HET·June 8, 2006
AF 840 PH.I.S.I.O. ARTERIAL FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
Single Use Electrosurgical Knife
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GALAXY WRIST STERILE KIT
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code KTT·January 13, 2021
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 11, 2015
ONE-STEP CENTESIS CATHETER
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code GBX·January 6, 2011
CAPSURE
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
FDA Recall
Terminated
·Orthofix Srl Via Delle Nazioni·Product code KTT·September 27, 2018
ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
FDA Enforcement
Class II
·Terminated·Orthofix Srl·November 20, 2019
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 26, 2019
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 8, 2019