5 results
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9ms
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Sources: EU EUDAMED, US FDA
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (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
Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
FDA Enforcement
Class II
·Ongoing·Covidien·May 8, 2024
biokitHSV-2 Rapid Test, REF: 300028001
FDA Enforcement
Class II
·Ongoing·Biokit, S.A.·February 1, 2023
Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.
FDA Enforcement
Class II
·Terminated·Medela AG Medical Technology·May 5, 2021
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024