en Español Date Issued: January 5, 2016 Audience:Health Care Providers in Puerto RicoStaff working at Health Care Facilities or Hospitals in Puerto Rico Product: Customed surgical convenience packs and trays contain instruments and other items that are used during surgical procedures, including general hospital, dental, and obstetrical and gynecological procedures. Surgical convenience packs include items…
Class I Medical Device Recall: Dräger Evita V500 and Babylog VN500 Ventilators
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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: Insulet Corporation OmniPod Insulin Management System: Needle May Fail to Deliver Insulin
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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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