Penumbra Inc.

FDA registration

Penumbra Inc.·1 product·🇺🇸 United States

Penumbra System (Reperfusion Catheters, Separators, Aspiration Tubing, and 3D Revascularization Device)

FDA registration

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

PENUMBRA, INC.

FDA registration

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

Penumbra Inc.

FDA registration

Penumbra Inc.·1 product·🇺🇸 United States

Penumbra Inc.

FDA registration

Penumbra Inc.·1 product·🇺🇸 United States

Penumbra System 3D Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheter, Thrombus Retriever

FDA classification

FDA Class 2 ·Catheter, Thrombus Retriever

Oticon

FDA UDI

Oticon A/S·05707131339119·SIYA 1, MRITE 312 2.4G NFM PB C093

INNESIS PEEK CAGE

FDA registration

BK MEDITECH, USA·1 product·🇺🇸 United States

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

INNESIS PEEK CAGE

FDA registration

BK MEDITECH CO., LTD.·1 product·🇰🇷 South Korea

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

HealthICH

FDA registration

Nano-X AI Ltd.·1 product·🇮🇱 Israel

CleverLock Guidewire Locking Device and Biopsy Cap

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE

FDA 510(k)

FDA Class 1 ·General Hospital

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

Polymer Patient Examination Glove

FDA classification

FDA Class 1 ·Polymer Patient Examination Glove