15 results · 43ms · Sources: EU EUDAMED, US FDA

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

FDA registration
EverFortune.AI Co., Ltd.·1 product·🇹🇼 Taiwan

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

FDA 510(k)
FDA Class 2 ·Radiology

Bernafon

FDA UDI
Bernafon AG·05711584114087·CZ5 B 105, 2.4G NFM SABE DEMO CORAL 5 GPL

Z-Span Plate System

FDA registration
ZAVATION·1 product·🇺🇸 United States

HE4 CC 5 Elecsys

FDA registration
ROCHE DIAGNOSTICS GMBH·3 products·🇩🇪 Germany

because Medtronic cases / trays are registered as accessories to the intervertebral fusion device with bone graft,

FDA registration
Avalign Delivery Systems Division·3 products·🇺🇸 United States

Novo Surgical Inc.

FDA UDI
NOVO SURGICAL, INC.·00842331155734·brown needle holder, convex jaws, fine serratio...

Medetz Surgical Instruments

FDA UDI
Medetz Surgical Instruments LLC·G22312126240·Fukasaku Hockey Knife BW 3mm OL 120mm (4 3/4")

Automated Radiological Image Processing Software

FDA classification
FDA Class 2 ·Automated Radiological Image Processing Software

Ultrasonic Scalpel

FDA registration
NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD·1 product·🇨🇳 China

NaturaLyte Liquid Acid Concentrate

FDA registration
Haemotec, a division of Fresenius Medical Care Canada Inc.·1 product·🇨🇦 Canada

ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

FDA 510(k)
FDA Class 2 ·Immunology

REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS

FDA 510(k)
FDA Class 2 ·Orthopedic

Test, Epithelial Ovarian Tumor Associated Antigen (He4)

FDA classification
FDA Class 2 ·Test, Epithelial Ovarian Tumor Associated Antigen (He4)

Arthroscope

FDA classification
FDA Class 2 ·Arthroscope