50 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Stat Profile Prime Plus Analyzer System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Patella Clamp
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215064051·
MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY
FDA 510(k)
FDA Class 2
·Cardiovascular
OLYMPUS EMPOWER H65
FDA Adverse Event
Malfunction
·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2020
INSPIRE 8F M
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 3, 2024
OT ULTRAMINI ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·July 27, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 17, 2014
INSPIRE 8F M
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·January 4, 2024
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025
INSPIRE OXYGENATOR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·December 11, 2025
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 20, 2021
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 11, 2020
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·December 23, 2020
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·July 24, 2025