17 results · 22ms · Sources: EU EUDAMED, US FDA

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Kenota 1 Total IgE; Kenota 1 (instrument)

FDA 510(k)
FDA Class 2 ·Immunology

Unity Total Knee System

FDA UDI
CORIN LTD·05056139232688·Down Rod

Intrigue

FDA UDI
LANCER ORTHODONTICS, INC.·00817573021215·INTRG WHISP ROTH CUS HK-11T +5A 022 LR

SPROTTE®

FDA UDI
Pajunk GmbH Medizintechnologie·04048223130032·SPROTTE® 27G x 123mm with magnification sterile

Sklar®

FDA UDI
SKLAR CORPORATION·10649111146534·SKLIT IRIS SCISS CVD S/S 4 1/2

SPROTTE®

FDA UDI
Pajunk GmbH Medizintechnologie·14048223001636·SPROTTE® effect...

SPROTTE®

FDA UDI
Pajunk GmbH Medizintechnologie·04048223108185·Distal Tip: SPROTTE® Proximal End: ISO 80369-7

ENDOCENTER

FDA 510(k)
FDA Class 2 ·Dental

TS3 TUBING SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD VENFLON¿ PRO SAFETY IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·February 4, 2022

GLIDEWELL HT IMPLANT Ø4.3 X 11.5 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 17, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

METRIX AIR

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·July 19, 2019

URISYS 1800

FDA Adverse Event
Malfunction ·ROCHE INSTRUMENT CENTER AG TEGIMENTA·Product code JIL·November 12, 2008

ACRYSOF RESTOR

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·August 26, 2011

ALTRX +4 NEUT 36IDX52OD

FDA Adverse Event
Injury ·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code LPH·July 17, 2013

Revogene, Catalog no. 610210. IVD test instrument

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