11 results
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40ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid
FDA 510(k)
FDA Class 2
·Dental
ZX-I POWER ADD ON
FDA 510(k)
FDA Class 2
·Physical Medicine
GPSCATH BALLON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 28, 2019
SYRINGE 20ML LL TIP CONV PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·February 20, 2019
NX3
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·June 17, 2013
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 24, 2011
ACCU-CHEK ® SMARTVIEW TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 15, 2014
THERMAGE CPT SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020
THERMAGE CPT SYSTEM TIP
FDA Adverse Event
Injury
·SOLTA MEDICAL INC·Product code GEI·November 30, 2022
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017