UCAST

FDA registration

DASSIET OY·1 product·🇫🇮 Finland

QuikRead go CRP

FDA registration

AIDIAN OY·3 products·🇫🇮 Finland

iCare; iCare tonometer

FDA registration

MARIACHI OY·2 products·🇫🇮 Finland

TRIUX™ neo

FDA registration

MEGIN OY·3 products·🇫🇮 Finland

UCAST

FDA registration

DASSIET OY·1 product·🇫🇮 Finland

Planmeca ProOne

FDA registration

Planmeca Oy·1 product·🇫🇮 Finland

STERIKING

FDA registration

WIPAK OY·1 product·🇫🇮 Finland

ANGIOGRAPHIC BALLOON CATHETER BY J LLOYD

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J

FDA 510(k)

FDA Class 3 ·Cardiovascular

ALLEN

FDA UDI

ALLEN MEDICAL SYSTEMS, INC.·00615521020156·LEFT - Allen Yellofin Elite

ALLEN

FDA UDI

ALLEN MEDICAL SYSTEMS, INC.·00615521020170·Right - Allen Yellofin Elite

Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)

FDA 510(k)

FDA Class 1 ·Physical Medicine

WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD

FDA 510(k)

FDA Class 2 ·Cardiovascular

WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIPOLAR BALLOON PACING CATHETER BY J-LLOYD

FDA 510(k)

FDA Class 2 ·Cardiovascular

NeoLSD MSMS kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Adept Medical Ltd

Manufacturer

🇳🇿 New Zealand·58 Basic UDI-DIs·80 Devices·2 Importers

21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)

FDA 510(k)

FDA Class 2 ·Radiology

21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)

FDA 510(k)

FDA Class 2 ·Radiology