ASTOFLO

FDA 510(k)

FDA Class 2 ·Hematology

BLOOD/FLUID WARMER MODEL DW-1000A

FDA 510(k)

FDA Class 2 ·Hematology

THERMAL ANGEL

FDA 510(k)

FDA Class 2 ·Hematology

THERMACYL BLOOD/FLUID WARMER

FDA 510(k)

FDA Class 2 ·Hematology

BELMONT BUDDY FLUID WARMER

FDA 510(k)

FDA Class 2 ·Hematology

THE BELMONT BUDDY LITE FLUID WARMER

FDA 510(k)

FDA Class 2 ·Hematology

SPIROLOOP

FDA 510(k)

FDA Class 2 ·Anesthesiology

BELMONT BUDDY PLUS FLUID WARMER

FDA 510(k)

FDA Class 2 ·Hematology

HE TEST

FDA 510(k)

FDA Class 2 ·Anesthesiology

BAIR HUGGER BLOOD/FLUID WARMER

FDA 510(k)

FDA Class 2 ·Hematology

MICROHEATER

FDA 510(k)

FDA Class 2 ·Hematology

THE BELMONT BUDDY LITE FLUID WARMER

FDA 510(k)

FDA Class 2 ·Hematology

PANDA HELIUM GAS ANALYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

ASTOTHERM PLUS, ASTOTUBES, ASTOLINE

FDA 510(k)

FDA Class 2 ·Hematology

BLOOD WARMER (CODE 4R4305)

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO THERMAL ANGEL

FDA 510(k)

FDA Class 2 ·Hematology

PRISMATHERM II, ASTOLINE

FDA 510(k)

FDA Class 2 ·Hematology

Surgical Innovations Ltd.

Manufacturer

263 Basic UDI-DIs·288 Devices·3 Importers·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Axonics Inc.

Manufacturer

🇺🇸 United States·24 Basic UDI-DIs·24 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

Insulet Corporation

Manufacturer

🇺🇸 United States·13 Basic UDI-DIs·16 Devices·1 Importer·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.