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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140018 added)
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Unique Device Identification: Convenience Kits
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Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals")
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Class I Medical Device Recall: bioMérieux SA Etest® PIP/TAZO/CON-4 PTC 256 – Potential for Test Result Error
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CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance
Introduction Why is CDRH posting lists of guidance documents it intends to issue? Does CDRH expect to complete the A-list and B-list? Why is CDRH posting a list of guidance documents as part of its retrospective review? How do I comment on these lists or a particular guidance document? What guidance documents is CDRH considering…
Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses
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Summary Information for: LifeVest Wearable Cardioverter Defibrillator Models 3000, 3100 and 4000
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Class I Medical Device Recall: Boston Scientific Corporation, Chariot Guiding Sheath May Break off During the Procedure
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Class I Medical Device Recall: Draeger Perseus A500 Anesthesia Workstation
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