17 results · 35ms · Sources: EU EUDAMED, US FDA

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PreludeEASE Hydrophilic Sheath Introducer

FDA 510(k)
FDA Class 2 ·Cardiovascular

Oticon

FDA UDI
Oticon A/S·05707131287274·RIA2 PRO, MINIRITE 312 WL TC

APEX Revision Knee

FDA UDI
Omni Life Science, Inc.·00841690122807·Modular Stem 25mm x 75mm

IRIS Anterior Cervical Plate System

FDA UDI
Life Spine, Inc.·00190837060794·Iris Fixation Pin

LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)

FDA 510(k)
FDA Class 2 ·Dental

VLOC9ABSORBABLE WOUND CLOSURE DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

IHEARTEST

FDA Adverse Event
Malfunction ·IHEAR MEDICAL, INC.·Product code EWO·August 17, 2022

KYPHON BONE CEMENT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019

1030489-2019-01423

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·May 29, 2013

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 10, 2011

FLEXIMA BILIARY STENT

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2008

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

OSTEOCOOL RF ABLATION SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020