17 results · 21ms · Sources: EU EUDAMED, US FDA

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JO H20 Water Based Personal Lubricant

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526814721·GENUMEDI PSS GREEN O

OSS™ Orthopedic Salvage System

FDA UDI
Biomet Orthopedics, LLC·00880304002487·

TiLock

FDA UDI
Genesys Orthopedics Systems LLC·M719G1504800·Pre-Bent Rod

SunMed

FDA UDI
SUNMED, LLC·20889483042820·CC GUEDEL A/W SZ 80mm PK/10

PDE PHOTODYNAMIC EYE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH

FDA 510(k)
FDA Class 2 ·Anesthesiology

X-SUIT NIR COVERED BILIARY METALLIC STENT

FDA Adverse Event
Malfunction ·MEDINOL LTD.·Product code FGE·December 27, 2017

LYNX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

GIA 60-3.8 SINGLE USE RELOADABLE STAPLER

FDA Adverse Event
Injury ·USSC PUERTO RICO·Product code GDW·June 16, 2011

CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MFJ·September 5, 2008

SOLITAIRE REVASCULARIZATION DEVICE

FDA Adverse Event
Injury ·COVIDIEN (IRVINE)·Product code NRY·July 25, 2017

EOS PMP, EOS PMP INTEGRATED

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2021

DIDECO EOS ECMO M PHISIO

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·May 13, 2021

SORIN LIFEKIT D905 EOS ECMO

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 14, 2021

EOS PMP, EOS PMP INTEGRATED

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·March 23, 2022

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017