Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)

EasyOne Air Spirometer

FDA registration

NDD MEDIZINTECHNIK AG·1 product·🇨🇭 Switzerland

EasyOne Sky Spirometer

FDA registration

NDD MEDIZINTECHNIK AG·1 product·🇨🇭 Switzerland

EasyOne Pro/Pro LAB

FDA registration

NDD MEDIZINTECHNIK AG·1 product·🇨🇭 Switzerland

EasyOne Pro Respiratory Analysis System

FDA registration

NDD MEDIZINTECHNIK AG·1 product·🇨🇭 Switzerland

EasyOne Pro LAB Respiratory Analysis System

FDA registration

NDD MEDIZINTECHNIK AG·1 product·🇨🇭 Switzerland

EasyOne FlowTube

FDA registration

NDD MEDIZINTECHNIK AG·1 product·🇨🇭 Switzerland

EasyOne Spirometer

FDA registration

NDD MEDIZINTECHNIK AG·1 product·🇨🇭 Switzerland

Easy on-PC Spirometer

FDA registration

NDD MEDIZINTECHNIK AG·1 product·🇨🇭 Switzerland

Spiro-SP TrueFlow Sensor

FDA registration

NDD MEDIZINTECHNIK AG·1 product·🇨🇭 Switzerland

EasyOne Filter FT

FDA registration

NDD MEDIZINTECHNIK AG·1 product·🇨🇭 Switzerland

KAYE SCOOT-ABOUT, MODEL SB1

FDA 510(k)

FDA Class 1 ·Physical Medicine

TheraSphere Y90 Glass Microspheres 5.0 GBq (US Commercial)

FDA UDI

BIOCOMPATIBLES UK LTD·05060116921410·TheraSphere Yttrium-90 Glass Microspheres 5.0 G...

TheraSphere Y90 Glass Microspheres 10.5 GBq (US Commercial)

FDA UDI

BIOCOMPATIBLES UK LTD·05060116921526·TheraSphere Yttrium-90 Glass Microspheres 10.5 ...

TheraSphere Y90 Glass Microspheres 10.0 GBq (US Commercial)

FDA UDI

BIOCOMPATIBLES UK LTD·05060116921519·TheraSphere Yttrium-90 Glass Microspheres 10.0 ...

TheraSphere Y90 Glass Microspheres 16.5 GBq (US Commercial)

FDA UDI

BIOCOMPATIBLES UK LTD·05060116921649·TheraSphere Yttrium-90 Glass Microspheres 16.5 ...

TheraSphere Y90 Glass Microspheres 14.5 GBq (US Commercial)

FDA UDI

BIOCOMPATIBLES UK LTD·05060116921601·TheraSphere Yttrium-90 Glass Microspheres 14.5 ...

TheraSphere Y90 Glass Microspheres 7.5 GBq (US Commercial)

FDA UDI

BIOCOMPATIBLES UK LTD·05060116921465·TheraSphere Yttrium-90 Glass Microspheres 7.5 G...

TheraSphere Y90 Glass Microspheres 12.0 GBq (US Commercial)

FDA UDI

BIOCOMPATIBLES UK LTD·05060116921557·TheraSphere Yttrium-90 Glass Microspheres 12.0 ...

TheraSphere Y90 Glass Microspheres 11.0 GBq (US Commercial)

FDA UDI

BIOCOMPATIBLES UK LTD·05060116921533·TheraSphere Yttrium-90 Glass Microspheres 11.0 ...