8 results
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40ms
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Sources: EU EUDAMED, US FDA
Early Bird Bleed Monitoring System
FDA UDI
SARANAS INC.·00866532000419·
Early Bird Bleed Monitoring System
FDA UDI
SARANAS INC.·00866532000402·
EARLY BIRD BLEED MONITORING SYSTEM
FDA Adverse Event
Injury
·SARANAS, INC.·Product code QFJ·January 16, 2023
EARLY BIRD BLEED MONITORING SYSTEM
FDA Adverse Event
Death
·SARANAS, INC.·Product code QFJ·February 26, 2023
EARLY BIRD BLEED MONITORING SYSTEM
FDA Adverse Event
Injury
·SARANAS, INC.·Product code QFJ·February 26, 2023
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
FDA Recall
Open, Classified
·Saranas, Inc.·Product code QFJ·August 10, 2022
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
FDA Enforcement
Class II
·Ongoing·Saranas, Inc.·September 14, 2022
CMC Medical Devices & Drugs SL
Authorized representative
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