Monarch Cart (MON-000008 - 210-007592)

FDA registration

Auris Health, Inc·3 products·🇺🇸 United States

Monarch Cart (MON-000008 - 210-007592)

FDA registration

Auris Health, Inc.·3 products·🇺🇸 United States

MONARCH™ Platform (MON-000008)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NIRO-200NX

FDA registration

HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION·2 products·🇯🇵 Japan

Affinity 2

FDA registration

DGS Diagnostics Sp. z o.o·2 products·🇵🇱 Poland

Affinity 2

FDA registration

INTERACOUSTICS A/S·2 products·🇩🇰 Denmark

Bronchoscope (Flexible Or Rigid)

FDA classification

FDA Class 2 ·Bronchoscope (Flexible Or Rigid)

FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)

FDA registration

BBF STERILISATIONSSERVICE GMBH·1 product·🇩🇪 Germany

SAMAPLAST AG

FDA registration

SAMAPLAST AG·1 product·🇨🇭 Switzerland

FLEX SFM System

FDA registration

GI WINDOWS·1 product·🇺🇸 United States

FiberLocker Instrument

FDA registration

ZURIMED TECHNOLOGIES AG·1 product·🇨🇭 Switzerland

MEDISTRI SA

FDA registration

MEDISTRI SA·1 product·🇨🇭 Switzerland

Trevo XP ProVue Retriever 6x25

FDA registration

Sterigenics U.S., LLC·2 products·🇺🇸 United States

NIRO-200NX

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Oximeter, Tissue Saturation

FDA classification

FDA Class 2 ·Oximeter, Tissue Saturation

Audiometer

FDA classification

FDA Class 2 ·Audiometer