Draeger Breathing Filter Gets Class I Recall
The Draeger SafeStar 55 has been identified by the U.S. FDA as a Class I recall, the most serious type of recall.
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Medtronic’s HVAD Pump Implant Kit Gets Class I Recall for Weld Defect
Medtronic recalled its HeartWare Ventricular Assist Device System, which is designed to help the heart pump blood to the rest of the body.
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House Subcommittee Debates Device Remanufacturing Definition, Sends User-Fees Bill to Next Stage
The House Energy and Commerce Health Subcommittee advanced legislation that would reauthorize U.S. FDA medical product user fee programs.
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Draeger Breathing Filter Gets Class I Recall
The Draeger SafeStar 55 has been identified by the U.S. FDA as a Class I recall, the most serious type of recall.
FDA Clears Bendit Technologies Microcatheter
Bendit has received U.S. FDA 510(k) clearance for its Bendit21 microcatheter for treatment in the neuro, peripheral, and coronary vasculature.
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Pear Therapeutics Gets FDA Safe Tech Designation for Product Candidate to Treat Pain
Pear Therapeutics received STeP for Medical Devices designation from the FDA for a product candidate aimed to treat acute and chronic pain.
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FDA Official: Draft Cybersecurity Guidance Has ‘Teeth’
The U.S. FDA’s draft cybersecurity guidance highlights the significant impact cybersecurity incidents have had on medical networks globally.
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FDA to Review Medical Device User Fee Amendments Through 2027
The FDA is holding a meeting to discuss the reauthorization of the Medical Device User Fee Amendments for fiscal years 2023 through 2027.
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Use Duodenoscopes with Innovative Designs to Enhance Safety, FDA Says
The U.S. FDA is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components.
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Medtronic Recalls 6,000 Drug-Coated Balloons Shipped in Potentially Unsterile Packaging
Medtronic is recalling a catheter product following uncertainty regarding whether packing for the item was sterile.
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Certain Karl Storz Urological Endoscopes Have Changed Reprocessing Methods, Says FDA
The FDA is aware that the current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are being updated.
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