9 results
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25ms
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Sources: EU EUDAMED, US FDA
ORTHO PATIENT CHAIR
FDA 510(k)
FDA Class 1
·Dental
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884304220·dentaform® Band, tooth 46, size 4/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884304180·dentaform® Band, tooth 46, size 4/Roth 18
YANNUZZI FUNDUS LASER LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
KEYMED OFFICE COUCH
FDA 510(k)
FDA Class 2
·General Hospital
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 19, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 22, 2012
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·October 27, 2010
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024