Zimmer Biomet announced U.S. FDA 510(k) clearance of the Identity Shoulder System for anatomic, reverse, and revision shoulder replacement.
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.Read More
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.Read More
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.Read More
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.Read More
The EndoFresh Disposable Digestive Endoscopy System features a camera system with an all-in-one design, disposable upper GI endoscope, and disposable colonoscope.Read More