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Nervous and medullary systems devices
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Encephalic and peripheral nervous system devices
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Neurophysiology devices
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Neurophysiology devices - other
Neurophysiology devices - other
N010199
436 devices
Keypoint Focus Workstation, DAN
Natus Manufacturing Limited
·
,
Ireland
Class IIa
CE/MDR
Subdermal Needles
Rhythmlink International, LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Subdermal Needles
Rhythmlink International, LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Adhesive electrodes
Spes Medica S.p.A.
·
,
Italy
Class I
CE/MDR
GUDID
on market
Surgical Instrument
Gimmi GmbH
·
,
Germany
Class I
CE/MDR
Neurotips
Owen Mumford Ltd
·
,
United Kingdom
Class I
CE/MDR
Sterile neuroprobe
Alpha Omega Engineering Ltd
·
,
Israel
Class III
CE/MDR
1000178902
Active
Valid to Nov 2028
GUDID
on market
Sienna Ultimate
EMS Handels Gesellschaft m.b.H.
·
,
Austria
Class IIa
CE/MDR
2024-MDR/QS-030
Active
Valid to Jun 2029
FDA 510(k)
K171397
Active
Cleared 6 Oct 2017
Frameless Microelectrode Holder + (Without screws)
Alpha Omega Engineering Ltd
·
,
Israel
Class I
CE/MDR
Control Panel, Keypoint G4
Natus Manufacturing Limited
·
,
Ireland
Class IIa
CE/MDR
Subdermal Needles
Rhythmlink International, LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Sterile cannula
Alpha Omega Engineering Ltd
·
,
Israel
Class III
CE/MDR
1000178902
Active
Valid to Nov 2028
GUDID
on market
Adhesive electrodes
Spes Medica S.p.A.
·
,
Italy
Class I
CE/MDR
Sterile neuroprobe
Alpha Omega Engineering Ltd
·
,
Israel
Class III
CE/MDR
1000178902
Active
Valid to Nov 2028
GUDID
on market
Natus Keypoint Focus Notebook System, Ita
Natus Manufacturing Limited
·
,
Ireland
Class IIa
CE/MDR
Natus Keypoint Focus Desktop System, Ger
Natus Manufacturing Limited
·
,
Ireland
Class IIa
CE/MDR
Sterile cannula
Alpha Omega Engineering Ltd
·
,
Israel
Class III
CE/MDR
1000178902
Active
Valid to Nov 2028
GUDID
on market
Sterile cannula
Alpha Omega Engineering Ltd
·
,
Israel
Class III
CE/MDR
1000178902
Active
Valid to Nov 2028
GUDID
on market
Sterile electrode's cable
Alpha Omega Engineering Ltd
·
,
Israel
Class I
CE/MDR
GUDID
on market
Adhesive electrodes
Spes Medica S.p.A.
·
,
Italy
Class I
CE/MDR
GUDID
on market
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