Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·TheraSphere

DJO, LLC

FDA registration

DJO, LLC·2 products·🇺🇸 United States

DJO, LLC

FDA registration

DJO, LLC·2 products·🇺🇸 United States

Insight Discovery

FDA registration

SRS MEDICAL·2 products·🇺🇸 United States

Verity Medical Ltd (Ireland)

FDA registration

Verity Medical Ltd (Ireland)·2 products·🇮🇪 Ireland

Verity Medical Ltd (Ireland)

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Verity Medical Ltd (Ireland)·2 products·🇮🇪 Ireland

MYOTRAC INFINITI SYSTEM

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THOUGHT TECHNOLOGY LTD.·2 products·🇨🇦 Canada

SA9020 - MyOnyx

FDA registration

THOUGHT TECHNOLOGY LTD.·2 products·🇨🇦 Canada

Freespira

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Freespira, Inc·2 products·🇺🇸 United States

mcompass Biofeedback Anorectal Manometry System.

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MEDSPIRA LLC·2 products·🇺🇸 United States

Medical HAL Lower Limb Type

FDA registration

CYBERDYNE INC.·2 products·🇯🇵 Japan

NeuroMove NM900

FDA registration

ZYNEX MEDICAL, INC.·2 products·🇺🇸 United States

Biofeedback Nerve and Muscle Stimulator (Models: KM530B, KM531B, KM536, KM537)

FDA registration

SHENZHEN KONMED TECHNOLOGY CO., LTD·2 products·🇨🇳 China

Yarlap II

FDA registration

RELEVIUM LABS, INCORPORATED·2 products·🇺🇸 United States

Aspire2

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SPECTRAMED, LLC·2 products·🇺🇸 United States

DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.

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DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.·2 products·🇲🇽 Mexico

InToneMV

FDA registration

INCONTROL MEDICAL, LLC·2 products·🇺🇸 United States

Canary Breathing System

FDA registration

Freespira, Inc·2 products·🇺🇸 United States

XFT, Nerve And Muscle Stimulator, Model XFT-2003K

FDA registration

SHENZHEN XFT MEDICAL LIMITED·2 products·🇨🇳 China

HAL for Medical Use Lower Limb Type

FDA registration

CYBERDYNE INC.·2 products·🇯🇵 Japan