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

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GOLFF Sterile Anti-Fog Solution

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

MILAGRO

FDA UDI
Medos International Sàrl·10886705022274·MILAGRO ADVANCE INTERFERENCE SCREW Absorbable -...

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022526·400 micron core/730 micron OD Luer Lock Diode L...

Ophthalmic Spoon

FDA UDI
KATENA PRODUCTS, INC.·00841668102206·LASEK ALCOHOL WELL 9.5MM

LifePath Remote Patient Monitoring Platform

FDA 510(k)
FDA Class 2 ·Cardiovascular

ULTRAEXTEND USWS-900A V2.1 AND V3.1

FDA 510(k)
FDA Class 2 ·Radiology

MENTOR SMOOTH ROUND SPECTRUM

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·March 25, 2019

MENTOR SMOOTH ROUND SPECTRUM

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·March 25, 2019

FREEDOM ONBOARD BATTERY

FDA Adverse Event
Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·October 15, 2014

ENDOSTAT ELECTROSURGICAL UNIT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·September 1, 2011

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 15, 2013

MILAGRO ADVANCE SCREW 9X30MM

FDA Adverse Event
Malfunction ·DEPUY MITEK LLC US·Product code HWC·January 23, 2019

MILAGRO ADVANCE SCREW 9X30MM

FDA Adverse Event
Injury ·DEPUY MITEK LLC US·Product code HWC·February 27, 2019

MILAGRO ADVANCE SCREW 9X30MM

FDA Adverse Event
Malfunction ·DEPUY MITEK LLC US·Product code HWC·September 12, 2018

Revogene, Catalog no. 610210. IVD test instrument

FDA Enforcement
Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022