13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Procedure Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996134224·LATERAL,REVERSE SLAP HAMMER
ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRE-LOADED BIOSTINGER HORNET
FDA 510(k)
FDA Class 2
·Orthopedic
GLIDEWELL HT IMPLANT Ø3.5 X 16 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 6, 2024
COBAS 6000 E 601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 18, 2018
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code GJS·November 14, 2009
ACRYSOF
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD / HUNTINGTON·Product code HQL·October 31, 2008
BARDEX I.C. COMPLETE CARE
FDA Adverse Event
Malfunction
·BARD·Product code KOD·August 11, 2011
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
COBAS 6000 E 601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 29, 2018
COBAS 6000 E 601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 10, 2017
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021