BEUDAMED
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    RAUMEDIC-PTO-MONITORING-SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL

    FDA 510(k)
    FDA Class 2 ·Neurology

    3TO GmbH

    Manufacturer
    🇩🇪 Germany

    ATO FORM GmbH

    Manufacturer
    🇩🇪 Germany

    SILICONE DRESSINGS, NON-COMBINED

    Device
    EU MDR · Eu Md Class 2a ·bess pro gmbh·On the market·10 countries

    SILICONE DRESSINGS, NON-COMBINED

    Device
    EU MDR · Eu Md Class 2a ·bess pro gmbh·On the market·10 countries

    ITOS standalone

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Voigtmann GmbH·1 device

    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

    dentalXrai Pro

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·dentalXrai GmbH·1 device

    DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

    FDA Enforcement
    Class II ·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025

    pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.

    FDA Enforcement
    Class II ·Terminated·Pro-Med Instruments Gmbh·December 13, 2017

    DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

    DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

    DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    FDA Enforcement
    Class I ·Terminated·Pro-Med Instruments Gmbh·September 26, 2018

    Physio Tape Sprunggelenk

    Device
    EU MDR · Eu Md Class 1 ·Pro Dimi Healthcare GmbH & Co. KG·On the market·3 countries

    Physio Tape Hand- und Kniegelenk

    Device
    EU MDR · Eu Md Class 1 ·Pro Dimi Healthcare GmbH & Co. KG·On the market·3 countries

    Physio Tape

    Device
    EU MDR · Eu Md Class 1 ·Pro Dimi Healthcare GmbH & Co. KG·On the market·1 country

    Physio Tape

    Device
    EU MDR · Eu Md Class 1 ·Pro Dimi Healthcare GmbH & Co. KG·On the market·6 countries

    Physio Tape

    Device
    EU MDR · Eu Md Class 1 ·Pro Dimi Healthcare GmbH & Co. KG·On the market·6 countries

    Physio Tape

    Device
    EU MDR · Eu Md Class 1 ·Pro Dimi Healthcare GmbH & Co. KG·On the market·6 countries