25 results · 27ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Orthopedic

ARTISTE SOLUTION WITH SYS_VB50 UPDATE

FDA 510(k)
FDA Class 2 ·Radiology

NNC GOLD ABUTMENT FOR BRIDGES

FDA 510(k)
FDA Class 2 ·Dental

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 17, 2023

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·June 16, 2025

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·June 16, 2025

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·October 22, 2025

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·February 12, 2025

530G INSULIN PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 22, 2014

ESSURE

FDA Adverse Event
Injury ·Product code HHS·June 21, 2013

SOLETRA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·July 14, 2011

CARDIOCHEK PLUS ANALYZERQ

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·August 18, 2022

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·July 28, 2023

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·May 24, 2024

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·January 6, 2023

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·January 11, 2024

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·November 21, 2023

SYNGO SUITE FOR ONCOLOGY SYSTEM

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·June 14, 2024

CARDIOCHEK PLUS ANALYZER

FDA Adverse Event
Malfunction ·PTS DIAGNOSTICS·Product code CGA·February 24, 2023