15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EASYDEX
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007539·SOSOFT 8-15 MM HG KNEE HIGH RIB MEDIUM BLACK 1 ...
ARGENCO W-LITE (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120247·Alloy other noble metal
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036031534·
ResQPOD ITD 16
FDA UDI
Zoll Medical Corporation·00847946028305·RESQPOD ITD 16, INTERNATIONAL
BD ULTRA-FINE NANO INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·December 22, 2020
DETAX IMPLANTLINK SEMI
FDA 510(k)
FDA Class 2
·Dental
COLORADO 2 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TROJAN PLEASURE PACK LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·May 20, 2013
AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·June 7, 2011
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·August 14, 2008
TRUE METRIX GO
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·January 13, 2022
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023