21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Synthes GmbH·10886982151568·2.4MM CANNULATED SCREW LONG THREAD 18MM
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2118180·2.4mm Cannulated Screw, Long Thread, 18mm
Diamond Orthopedic, LLC
FDA UDI
DIAMOND ORTHOPEDIC, LLC·B551DMD2118180·2.4mm, Cannulated Screw, Long Thd., 18mm
SONIXGPS NEEDLE SENSOR
FDA 510(k)
FDA Class 2
·Radiology
STERILE EMG ELECTRODES
FDA 510(k)
FDA Class 2
·Physical Medicine
A Plus
FDA UDI
A PLUS INTERNATIONAL INC.·00683534840412·18"X18", Prewashed, Rigid Pack (Rectangular Fol...
A Plus
FDA UDI
A PLUS INTERNATIONAL INC.·00683534840405·18"X18", Unwashed (Square Fold), Bleached White...
A Plus
FDA UDI
A PLUS INTERNATIONAL INC.·00683534840429·18"X18", Prewashed, Plastic Ring (Rectangular F...
A Plus
FDA UDI
A PLUS INTERNATIONAL INC.·00683534840252·Sterile Lap Sponges , 18"X18", Prewashed (Recta...
A Plus
FDA UDI
A PLUS INTERNATIONAL INC.·00683534840436·18"X18", Prewashed, No Loop (Square Fold), Blea...
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·August 10, 2011
5MM REVERSE CURETTE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JXE·October 29, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012