12 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMSI GARMENT ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
BABY DOPPLEX 3000 MK 2 (BD3000)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SENOJ IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
GMK-SPHERE 02.12.0002R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 28, 2022
HT70 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 13, 2017
NEWPORT
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 16, 2017
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 7, 2021
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·September 15, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·April 26, 2011
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 22, 2024