43 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Medidenta High Speed Handpieces
FDA 510(k)
FDA Class 1
·Dental
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112595·BARRON CORNEAL PUNCH 7.0MM
Adhesive Electrodes
FDA UDI
COMPASS HEALTH BRANDS CORP.·00850689007513·1.5"x 3.5" Cloth
Adhesive Electrodes
FDA UDI
COMPASS HEALTH BRANDS CORP.·10850689007510·1.5"x 3.5" Cloth, Case of 10
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 11, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 11, 2022
BIRD AVEA VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
RANDOX MICROALBUMIN
FDA 510(k)
FDA Class 2
·Immunology
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2025
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2023
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 31, 2024
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 21, 2026
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2023
GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 21, 2023
VIASYS
FDA Adverse Event
Malfunction
·CAREFUSION 207, INC·Product code CBK·October 26, 2009
3202674-005 REDIPAK 1P 10B 50C
FDA Adverse Event
Malfunction
·COVIDIEN·Product code DRO·January 13, 2020
3202674-005 REDIPAK 1P 10B 50C
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code MKJ·January 19, 2022
3202674-005 REDIPAK 1P 10B 50C
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code MKJ·January 19, 2022
3202674-005 REDIPAK 1P 10B 50C
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code MKJ·January 19, 2022