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H500 Multi-Sensing Oximetry System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Syringe, Calibration, 3 Liter, Aluminum, Eliptical Cap

FDA UDI
A-M SYSTEMS, LLC·00817081026641·Syringe, Calibration, 3 Liter, Aluminum, Elipti...

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025

HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025

CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FDX·February 22, 2021

ACDF STAND ALONE CERVICAL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

FLANGE FIXTURE AND ABUTMENT

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 27, 2013

NEURON DELIVERY CATHETER 070

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code DQY·July 25, 2011

ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023

FUSION CYTOLOGY BRUSH

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code FDX·January 6, 2022

FUSION CYTOLOGY BRUSH

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FDX·October 25, 2021

CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code FDX·May 4, 2022

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·March 27, 2020

CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code FDX·November 14, 2022

CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDX·August 27, 2024

FUSION CYTOLOGY BRUSH

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code FDX·July 31, 2024