30 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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