27 results · 42ms · Sources: EU EUDAMED, US FDA

uTASWako AFP-L3 Control L and H

FDA registration
FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)·5 products·🇯🇵 Japan

uTASWako AFP-L3 Control L and H

FDA registration
FUJIFILM Healthcare Manufacturing Corporation MIE Office·5 products·🇯🇵 Japan

FUJIFILM Healthcare Americas Corporation

FDA registration
FUJIFILM Healthcare Americas Corporation·5 products·🇺🇸 United States

FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office

FDA registration
FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office·5 products·🇯🇵 Japan

UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION

FDA 510(k)
FDA Class 2 ·Immunology

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification
FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Bur PM2-70 80K FC Ø2.0 St

FDA UDI
Bien-Air Surgery SA·17630055504194·

Osstell SmartPeg Type 42

FDA UDI
Osstell AB·09010522001523·ISQ Measurement Peg

SONTEC SATINSKY BULLDOG CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002357·SONTEC SATINSKY BULLDOG CLAMP DOUBLE ANGLED

SONTEC SATINSKY BULLDOG CLAMP

FDA UDI
SONTEC INSTRUMENTS, INC.·B09921004640·SONTEC SATINSKY BULLDOG CLAMP DOUBLE ANGLED

CARTRIDGE BLOOD SET

FDA registration
Vantive US Healthcare LLC·1 product·🇺🇸 United States

Neutron

FDA registration
ICU MEDICAL, INC·2 products·🇺🇸 United States

Isomedix Operations, Inc

FDA registration
Isomedix Operations, Inc·1 product·🇺🇸 United States

Isomedix Operations Inc.

FDA registration
Isomedix Operations Inc.·2 products·🇺🇸 United States

Isomedix Operations, Inc

FDA registration
Isomedix Operations, Inc·2 products·🇺🇸 United States

Neutron

FDA registration
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.·2 products·🇲🇽 Mexico

Administration Sets and Accessories

FDA registration
Sterigenics Radiation Technologies, LLC·1 product·🇺🇸 United States

CARTRIDGE BLOOD SET

FDA registration
GAMBRO RENAL PRODUCTS S.A. DE C.V.·1 product·🇲🇽 Mexico

CARTRIDGE LOW WEIGHT LOWVOLUME

FDA registration
Sterigenics U.S., LLC·1 product·🇺🇸 United States

Tether™

FDA UDI
SEASPINE ORTHOPEDICS CORPORATION·10889981035709·Plate - 4 Level - 64mm