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June 18, 2019
June 17, 2019
- Consumer Information on: TransMedics OCS Lung System - P160013/S002
- Meeting Materials posted for June 19-20, 2019 Circulatory System Devices Panel
June 12, 2019
- Mouse Embryo Assay for Assisted Reproduction Technology Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Mouse Embryo Assay for Assisted Reproduction Technology Devices
June 11, 2019
June 10, 2019
June 7, 2019
- Webcast Links posted for June 19-20, 2019 Circulatory System Devices Panel
- Press Release: FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age
June 6, 2019
June 5, 2019
June 4, 2019
June 3, 2019
May 31, 2019
May 30, 2019
- Class I Recall: Terumo Medical Corporation Recalls SOLOPATH® Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System Due to Dislodgement of the Fairing Tip from the Sheath
- Mammography Facility Adverse Event and Action Report - May 30, 2019: East Palestine Family Medical Clinic Inc.
May 28, 2019
- Federal Register: Notice: Review and Update of Device Establishment Inspection Processes and Standards; Extension of Comment Period
- Meeting materials posted for May 30-31, 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
May 24, 2019
- Class I Recall: lntegra LifeSciences Recalls the LimiTorr Volume Limiting CSF Drainage System and the MoniTorr ICP External CSF Drainage and Monitoring System Due to Possible Breakage of the LimiTorr Transducer and MoniTorr Panel Mount Stopcock
- Class I Recall: Edwards Lifesciences LLC Recalls EV1000 Clinical Platforms Due to Electrical Short Circuit Which May Cause the Device to Stop Working or Catch Fire
- Federal Register: Amendment of Notice: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
- Federal Register: Notice: Determination of Regulatory Review Period for Purposes of Patent Extension: EDWARDS INTUITY ELITE AORTIC VALVE
- AMENDMENT OF NOTICE: May 30-31, 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
May 23, 2019
- UPDATE On Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors - Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures
- Class I Recall: Beckman Coulter Life Sciences Recalls DxH800 and DxH600 and DxH 900 Hematology Analyzers Due to Risk of Inaccurate Results
- Consumer Information on: LOTUS Edge™ Valve System - P180029
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180069 and DEN180032 added)
- Historical Information about Device Emergency Use Authorizations
- Consumer Information: NovoTTF™-100L System - H180002
- Press Release: FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results
- Press Release: FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
- Press Release: FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
May 22, 2019
- Digital Health Software Precertification (Pre-Cert) Program: Participate in 2019 Test Plan
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180059 added)
May 21, 2019
- UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers
- Warning Letter to Zeller Power Products, LLC
- Consumer Information: VICI VENOUS STENT® System - P180013
May 20, 2019
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals
- Press Release: FDA Warns Against the Use of Unauthorized Devices for Diabetes Management
May 17, 2019
- FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication
- Patient-Reported Outcomes (PROs) in Medical Device Decision Making
- Federal Register: Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I; Correction
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