129 results · 22ms · Sources: EU EUDAMED, 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