72 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U60 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
BI-METRIC XR-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304650527·
CoRoent
FDA UDI
Nuvasive, Inc.·00887517575951·CoRoent Ant TLIF Ti, 8x10x40mm 8°
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486000462·MCK Patellofemoral Component
FUKUSHIMA SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·B0991804080·FUKUSHIMA SUCTION TUBE
FUKUSHIMA SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896000353·FUKUSHIMA SUCTION TUBE
ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD
FDA 510(k)
FDA Class 2
·Orthopedic
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
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·June 9, 2023
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 17, 2014
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 27, 2011
INSPIRE 8F M
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·January 4, 2024
T:SLIM G5 SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code OYC·December 13, 2019
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
RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code HRY·September 12, 2014