17 results
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54ms
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Sources: EU EUDAMED, US FDA
BOLDER SURGICAL, LLC
FDA registration
BOLDER SURGICAL, LLC·3 products·🇺🇸 United States
JUST RIGHT 5MM STAPLER
FDA Adverse Event
Injury
·BOLDER SURGICAL, LLC·Product code GAG·May 23, 2022
JUSTRIGHT 5MM STAPLER
FDA Adverse Event
Malfunction
·BOLDER SURGICAL, LLC·Product code GAG·May 6, 2024
JUSTRIGHT 5MM STAPLER
FDA Adverse Event
Malfunction
·BOLDER SURGICAL, LLC·Product code GAG·May 6, 2024
BOLDER SURGICAL JUSTRIGHT STAPLER 5MM
FDA Adverse Event
Injury
·BOLDER SURGICAL LLC·Product code GAG·July 21, 2021
JUSTRIGHT 5MM STAPLER
FDA Adverse Event
Malfunction
·BOLDER SURGICAL, LLC·Product code GAG·May 9, 2023
COOLSEAL¿
FDA Adverse Event
Malfunction
·BOLDER SURGICAL, LLC·Product code GEI·April 23, 2025
COOLSEAL TRINITY
FDA Adverse Event
Malfunction
·BOLDER SURGICAL, LLC·Product code GEI·October 3, 2023
JustRight 5mm Stapler
FDA Adverse Event
Malfunction
·BOLDER SURGICAL, LLC·Product code GAG·January 25, 2022
COOLSEAL REVEAL
FDA Adverse Event
Malfunction
·JUSTRIGHT SURGICAL, LLC / BOLDER SURGICAL·Product code GEI·August 9, 2024
JUST RIGHT 5MM STAPLER 12 MM
FDA Adverse Event
Malfunction
·JUSTRIGHT SURGICAL / BOLDER SURGICAL, LLC·Product code GAG·September 16, 2020
JUSTRIGHT 5MM STAPLER
FDA Adverse Event
Malfunction
·JUSTRIGHT SURGICAL, LLC / BOLDER SURGICAL·Product code GAG·January 26, 2022
JUST RIGHT VESSEL SEALING SYSTEM
FDA Adverse Event
Injury
·JUST RIGHT SURGICAL / BOLDER SURGICAL, LLC.·Product code GEI·December 15, 2021
CoolSeal Generator, REF: CSL-200-50
FDA Recall
Terminated
·Bolder Surgical, LLC·Product code GEI·January 25, 2022
CoolSeal Generator, REF: CSL-200-50
FDA Enforcement
Class II
·Terminated·Bolder Surgical, LLC·March 16, 2022
ab medica spa
Importer
🇮🇹 Italy·10 Manufacturers
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices