17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TROJAN PLEASURE PACK LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014
ARGENCO WR+ (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120249·Alloy other noble metal
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007553·SOSOFT 8-15 KH RIB S SAND 1 EN FR ES
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450193938·
EXPEDIUM SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 20, 2013
GENESISXP CONVENTIONAL IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 7, 2011
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
NEEDLE, HYPODERMIC, SINGLE LUMEN
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018
NEEDLE, HYPODERMIC, SINGLE LUMEN
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 13, 2018
SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 6, 2024
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 2, 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