15 results
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48ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FIREFLY MEDICAL, INC.
FDA registration
FIREFLY MEDICAL, INC.·1 product·🇺🇸 United States
IVEA
FDA UDI
Firefly Medical, Inc.·00850003110103·IVEA is an innovative, 4-wheeled mobile patient...
Oxygen (O2) Tank Booster Accessory for IVEA
FDA UDI
Firefly Medical, Inc.·00850003110110·An accessory that attaches to IVEA to allow com...
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·January 2, 2025
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·December 26, 2024
DAVINCI X
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·June 16, 2022
ENDOWRIST
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·February 3, 2026
IVEA 500A Intended for Med-Surg patient care.
FDA Recall
Terminated
·Firefly Medical, Inc.·Product code FOX·November 1, 2016
IVEA Product Part Number 16100 Model 500A
FDA Recall
Terminated
·Firefly Medical, Inc.·Product code FOX·August 24, 2017
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·June 29, 2022
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·August 7, 2023
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·September 19, 2025
HARMONIC ACE 5MM SHEAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 22, 2025
IVEA 500A Intended for Med-Surg patient care.
FDA Enforcement
Class II
·Terminated·Firefly Medical, Inc.·December 21, 2016
IVEA Product Part Number 16100 Model 500A
FDA Enforcement
Class II
·Terminated·Firefly Medical, Inc.·October 11, 2017