2 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024