157 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring
FDA 510(k)
FDA Class 2
·Dental
FAC-4 - Duke Power Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015293·FAC-4 - Duke Power Cabinet
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669
FDA 510(k)
FDA Class 1
·Clinical Chemistry
D2RF DIGITAL DYNAMIC REMOTE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN PROGRIP MESH PRODUCT
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·January 8, 2025
UNKNOWN PROGRIP MESH PRODUCT
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·December 5, 2025
UNKNOWN PARIETEX PRODUCT
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·December 5, 2025
PD1400 DEFIBRILLATOR/PACEMAKER
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code LDD·October 8, 2008
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 5, 2011
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·July 2, 2013
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN LP LLC NORTH HAVEN·Product code GAM·January 8, 2025
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 8, 2026
ILET BIONIC PANCREAS
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·September 25, 2025
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 1, 2026
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 30, 2026
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·January 17, 2025
NI
FDA Adverse Event
Injury
·VANTIVE US HEALTHCARE LLC·Product code KDJ·May 19, 2025
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 4, 2026
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·May 4, 2026
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 17, 2026