129 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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APPLE ECG (ELECTROCARDIOGRAPH) APP
FDA Adverse Event
Injury
·APPLE INC.·Product code QDA·July 5, 2023
ECG App
FDA 510(k)
FDA Class 2
·Cardiovascular
FAC-4 - Duke Power Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015293·FAC-4 - Duke Power Cabinet
18M - Loggers - 18 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015057·18M - Loggers - 18 Metal
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365115745·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450237908·
NA
FDA UDI
DEPUY (IRELAND)·10603295082415·Marathon XLPE Cemented Cup T-Handle
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450412947·
TOPCUT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
Meduloc Intramedullary Fracture Fixation (IFF) System
FDA UDI
MEDULOC, LLC·00810184540359·Sterile Meduloc IFF System Implant Kit (2.5L)
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·October 17, 2008
SJM EPIC STENTED PORCINE HEART VALVE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code LWR·June 28, 2013
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 4, 2011
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 8, 2026
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
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