8 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 17, 2020
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015