3 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·September 3, 2014
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
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024