2,074 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electrode, Nasopharyngeal
FDA classification
FDA Class 2
·Electrode, Nasopharyngeal
GVK CORPORATION
FDA registration
GVK CORPORATION·1 product·🇺🇸 United States
Intuitive Surgical G.K.
FDA registration
Intuitive Surgical G.K.·16 products·🇯🇵 Japan
Zimmer Biomet G.K.
FDA registration
Zimmer Biomet G.K.·46 products·🇯🇵 Japan
Arthrex Japan G.K. (Shinjuku)
FDA registration
Arthrex Japan G.K. (Shinjuku)·31 products·🇯🇵 Japan
Medline Logistics Japan G.K.
FDA registration
Medline Logistics Japan G.K.·1 product·🇯🇵 Japan
Performa®
FDA UDI
Merit Medical Systems, Inc.·00884450245422·
GMK Hinge, GMK Revision
FDA 510(k)
FDA Class 2
·Orthopedic
GMK Sphere & GMK SpheriKA Cementless
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
GTK Trocars
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GMK SPHERE
FDA 510(k)
FDA Class 2
·Orthopedic
GMK Sphere
FDA 510(k)
FDA Class 2
·Orthopedic
GMK NARROW
FDA 510(k)
FDA Class 2
·Orthopedic
GMK UNI
FDA 510(k)
FDA Class 2
·Orthopedic
GMK EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
GMK HINGE
FDA 510(k)
FDA Class 2
·Orthopedic
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044207453·P TIP 500-1000UL OX AB PF QP
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044201055·15 mL Sterile Centrifuge Tubes with Screw Caps
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