10,000 results
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141ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Iga, Rhodamine, Antigen, Antiserum, Control
FDA classification
FDA Class 2
·Iga, Rhodamine, Antigen, Antiserum, Control
C&C
FDA UDI
RELIANCE ORTHODONTIC PRODUCTS INC·D798CCK0·This product is intended for use by a dental pr...
ImmuView COVID-19 Antigen Home Test
FDA UDI
CTK BIOTECH INC.·00855402007979·The lmmuView® COVID-19 Antigen Home Test is a l...
ImmuView COVID-19 Antigen Home Test
FDA UDI
CTK BIOTECH INC.·00855402007955·The lmmuView® COVID-19 Antigen Home Test is a l...
ImmuView COVID-19 Antigen Home Test
FDA UDI
CTK BIOTECH INC.·00855402007962·The lmmuView® COVID-19 Antigen Home Test is a l...
CTK BIOTECH, INC.
FDA registration
CTK BIOTECH, INC.·62 products·🇺🇸 United States
CARCINO-CEK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
56800 Chair Conversion Kit
FDA UDI
ACCUTRON, INC.·00813830024586·
BioHorizons
FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236016920·Overdenture Caps Assortment Kit (2 pack)
Compliance BronchKit™
FDA UDI
BOSTON SCIENTIFIC CORPORATION·00840253119469·Compliance BronchKit™
Compliance BronchKit™
FDA UDI
BOSTON SCIENTIFIC CORPORATION·00840253119476·Compliance BronchKit™
Chair Conversion Kit
FDA UDI
ACCUTRON, INC.·00813830024579·
BioHorizons
FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236012519·ODSecure Assortment Kit (2 pack)
CAD/CAM Abutment Kit Narrow
FDA UDI
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10810190018795·
CAD/CAM Abutment Kit Narrow Round
FDA UDI
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10810190018801·
Casco Cup
FDA UDI
CASCO BAY MOLDING LTD.·00850004683507·
EVOLUTION Revision CCK System
FDA 510(k)
FDA Class 2
·Orthopedic
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·February 11, 2026
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·February 11, 2026
Basic Kit
FDA UDI
Chromsystems Instruments + Chemicals GmbH·04250317557582·HPLC Basic Kit, Catecholamines in urine, Combin...