26 results · 24ms · Sources: EU EUDAMED, US FDA

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The iNAP One Sleep Therapy System

FDA 510(k)
FDA Class 2 ·Dental

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169599413·TRIAL 2193460 O25 IB 27MM 18 DEG 14X60

HHM

FDA UDI
Oticon A/S·05707131343611·G100, MINIRITE 312 2.4G C093 HHM

COAGUCHEK XS PRO SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

SYNERGY TISSUE MATRIX

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

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

NA

FDA Adverse Event
Malfunction ·ASCENT HEALTHCARE SOLUTIONS·Product code NLQ·October 8, 2008

LUMAX 540 HF-T

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code NIK·June 27, 2013

MULTI-LUMEN PI CVC KIT: 3-L FR X 8IN (2

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code FOZ·July 13, 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

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