29 results · 23ms · Sources: EU EUDAMED, US FDA

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CS 8100 3D

FDA 510(k)
FDA Class 2 ·Radiology

HHM

FDA UDI
Oticon A/S·05707131262097·H110, RITE 312 WL SIL HHM

DreamWear Full

FDA UDI
Respironics, Inc.·00606959045927·DreamWear Full Mask, M, w/M Frame w/o Headgear,...

WESTCOTT TENOTOMY SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896014572·WESTCOTT TENOTOMY SCISSORS CURVED BLUNT BLADE S...

SMALL BONE FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS

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

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

M2A MAGNUM MODULAR HEAD

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code KWA·June 14, 2011

COBAS INTEGRA 800

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 22, 2008

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