16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
FDA 510(k)
FDA Class 2
·Cardiovascular
SUREFIRE INFUSION CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE
FDA 510(k)
FDA Unclassified
·Unknown
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973257·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973301·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970041·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970065·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970799·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973837·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970058·
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 26, 2022
TAPER SLEEVE ADAPTER 12/14 +8
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 20, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code EOQ·June 10, 2011
MICRUSFRAME10 4MM X 11.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·December 15, 2021
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