14 results · 19ms · Sources: EU EUDAMED, 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