ELECSYS CEA ON THE ELECSYS 1010

FDA 510(k)

FDA Class 2 ·Immunology

CLINETICS PCA COLUMN

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)

FDA 510(k)

FDA Class 2 ·Immunology

DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883

FDA 510(k)

FDA Class 2 ·Cardiovascular

IHX 6-18

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Esaote S.p.A.·1 device

IGUIDE CAPPA

FDA 510(k)

FDA Class 2 ·Radiology

NRX Loop Heat Tape

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Mediroyal Nordic AB·1 device

NRX Loop Heat Tape

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Mediroyal Nordic AB·1 device

NOX-SAS Head Cable

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Nox Medical·4 devices

Nox RIP Belts Disposable

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Nox Medical·10 devices

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE™ NXT Remote Patient Management System, LATITUDE™Wave Communicator, LATITUDE™ Consult Communicator, LATITUDE™ NX

MULTI-MED, INC.

FDA registration

MULTI-MED, INC.·1 product·🇺🇸 United States

Transpak

FDA registration

TechNH, INC.·1 product·🇺🇸 United States

ProSoft Nasal Cannula

FDA registration

Vapotherm Inc.·1 product·🇺🇸 United States

Calcitonin ELISA

FDA registration

American Laboratory Products Company·1 product·🇺🇸 United States

Extravascular support for an arteriovenous fistula for vascular access

FDA registration

Resonetics, LLC·1 product·🇮🇱 Israel

CORBIN HVE Adapter

FDA registration

SPECIALIZED CARE CO INC·1 product·🇺🇸 United States

SyvekExcel Bandage

FDA registration

LYOPHILIZATION SERVICES OF NEW ENGLAND, INC.·1 product·🇺🇸 United States

ARCH Medical Solutions - Seabrook

FDA registration

ARCH Medical Solutions - Seabrook·1 product·🇺🇸 United States

ARCH Medical Solutions - Seabrook

FDA registration

ARCH Medical Solutions - Seabrook·3 products·🇺🇸 United States