Zimmer Biomet Gets FDA Clearance for Shoulder Replacement System
Zimmer Biomet announced U.S. FDA 510(k) clearance of the Identity Shoulder System for anatomic, reverse, and revision shoulder replacement.
Category: Clearances
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FDA OKs Biotronik Programmer for Implanted Cardiac Rhythm Management Devices
Lake Oswego, Ore.-based Biotronik, Inc. announces that it has received U.S. FDA approval of Renamic Neo, the company’s programmer for implanted cardiac rhythm management devices such as ICDs, pacemakers, and implantable cardiac monitors.
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FDA OKs GE Healthcare AI X-ray Technology
GE Healthcare announces that it has received U.S. FDA 510(k) clearance for an artificial intelligence algorithm to help clinicians assess endotracheal tube placements.
Clearances
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Zimmer Biomet Gets FDA Clearance for Shoulder Replacement System
Zimmer Biomet announced U.S. FDA 510(k) clearance of the Identity Shoulder System for anatomic, reverse, and revision shoulder replacement.
FDA Clears 3NT Medical’s Sinus Endoscope
Short Hills, N.J.-based 3NT Medical announces that the U.S. FDA has cleared its single-use Peregrine Drivable ENT Scope, which is designed to provide ear, nose, and throat surgeons with advanced views of the sinus anatomy.
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Asensus Surgical Nabs FDA 510(k) Clearance for Articulating Instruments
Research Triangle Park, N.C.-based Asensus Surgical, Inc. announces that it has received U.S. FDA 510(k) clearance for 5 mm diameter articulating instruments, adding to the Senhance Surgical System technology platform.
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FDA Clears Fujifilm’s Endosurgical Image Enhancement Technology for Eluxeo Surgical System
FDA has granted 510(k) clearance for Fujifilm’s new image enhancement technology, the Oxygen Saturation Endoscopic Imaging System, which was developed to improve visualization during gastrointestinal, colorectal, and advanced endoscopy and surgical procedures.
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FDA Clears Penumbra Red 62 Reperfusion Catheter for Stroke Patients
Penumbra announces U.S. FDA 510(k) clearance and commercial availability of the Red 62 Reperfusion Catheter, the latest addition to the company’s comprehensive Penumbra System.
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Why Courts Should Bring Back Evidence of FDA Clearance in Medical Device Trials
Not allowing medical device companies to present information about the FDA’s analysis of their products in product liability cases against them results in unfair court trials, posits an article by Reuters.
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FDA Clears EndoFresh Disposable Digestive Endoscopy System
The EndoFresh Disposable Digestive Endoscopy System features a camera system with an all-in-one design, disposable upper GI endoscope, and disposable colonoscope.
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FDA Clears GE Healthcare AI MRI Technology
Waukesha, Wis.-based GE Healthcare announces that AIR Recon DL, a deep-learning image reconstruction technology that works across all anatomies, is now U.S. FDA 510(k) cleared on Signa 7.0T MRI scanners.
