11 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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3TO GmbH
Manufacturer
🇩🇪 Germany
ATO FORM GmbH
Manufacturer
🇩🇪 Germany
MAGNETOTHERAPY EQUIPMENT
Device
EU MDD
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Eu Md Class 2a
·gbo Medizintechnik AG·On the market·3 countries
PelviPower
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·gbo Medizintechnik AG·1 device
ITOS standalone
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Voigtmann GmbH·1 device
G1 032017 0012
Certificate
MDD Annex II (excluding section 4)·gbo Medizintechnik AG·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
FDA Enforcement
Class II
·Terminated·Spiegelberg Gmbh & Co. KG·October 5, 2016
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
FDA Enforcement
Class II
·Terminated·Brainlab AG·March 21, 2018
S.B. Pharma GmbH
Authorized representative
🇩🇪 Germany·29 Manufacturers·13 Devices
GTM Solution GmbH
Authorized representative
🇩🇪 Germany
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices