15 results
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43ms
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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