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RAPHAEL 25 Anchor

FDA UDI
OTS MEDICAL LTD·07290019507000·"Raphael 25 is an all-suture anchor. It is a so...

RAPHAEL 25 Instrument Kit

FDA UDI
OTS MEDICAL LTD·07290019507062·Raphael 25 is an all-suture anchor. It is a sof...

RAPHAEL 25 Anchor

FDA UDI
OTS MEDICAL LTD·07290019507031·Raphael 25 is an all-suture anchor. It is a sof...

RAPHAEL 25 Anchor

FDA UDI
OTS MEDICAL LTD·07290019507048·"Raphael 25 is an all-suture anchor. It is a so...

RAPHAEL 25 Instrument Kit

FDA UDI
OTS MEDICAL LTD·07290019507079·Raphael 25 is an all-suture anchor. It is a sof...

PROTEUS

FDA Adverse Event
Injury ·GE HANGWEI MEDICAL SYSTEMS CO., LTD.·Product code KPR·April 9, 2026

EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

FDA Recall
Terminated ·Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario·Product code GWF·January 2, 2015

EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.

FDA Recall
Terminated ·Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario·Product code GWE·January 2, 2015

Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.

FDA Recall
Terminated ·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code GWQ·November 11, 2015

OBS Medical Ltd

Manufacturer
2 Basic UDI-DIs·2 Devices·SGS Belgium NV

OBS Medical Ltd

FDA registration
OBS Medical Ltd·1 product·🇬🇧 United Kingdom

Visensia V4.2.1.50

Device
EU MDD · Eu Md Class 2a ·OBS Medical Ltd·On the market·32 countries

Extubation Advisor v1.4.6.84

Device
EU MDD · Eu Md Class 2b ·OBS Medical Ltd·On the market·32 countries

Extubation Advisor

Basic UDI-DI
EU MDD · Eu Md Class 2b ·OBS Medical Ltd·1 device

Visensia

Basic UDI-DI
EU MDD · Eu Md Class 2a ·OBS Medical Ltd·1 device

WOOD OPTIC DIFFUSION

Manufacturer
🇱🇺 Luxembourg

LUX-SUTURES S.A.

Manufacturer
🇱🇺 Luxembourg

TEXTILCORD STEINFORT SA

Manufacturer
🇱🇺 Luxembourg

B Medical Systems S.à r.l.

Manufacturer
🇱🇺 Luxembourg·15 Basic UDI-DIs·125 Devices

pjur group Luxembourg S.A

Manufacturer
🇱🇺 Luxembourg