34 results · 40ms · Sources: EU EUDAMED, US FDA

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Elite iQ

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 4, 2024

ELITE IQ

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 6, 2024

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 25, 2025

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·September 21, 2021

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 21, 2026

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·December 17, 2021

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 13, 2022

ELITE IQ

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·September 16, 2025

ELITE IQ

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 20, 2022

ELITE IQ

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 4, 2022

BACT-TRAP HEPA MIDI

FDA 510(k)
FDA Class 2 ·Anesthesiology

LITE PELVIC FLOOR REPAIR KITS

FDA 510(k)
FDA Class 3 ·Obstetrics/Gynecology

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

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·October 8, 2008

SOS SOFT VU TIP

FDA Adverse Event
Malfunction ·ANGIODYNAMICS·Product code DQO·June 21, 2013

NATURAL-KNEE SYSTEM HTO BONE FIXATION PLATE

FDA Adverse Event
Malfunction ·ZIMMER INC·Product code HRS·July 13, 2011