Lydus Medical Announces FDA Clearance of Microvascular Anastomosis Aid Device
Lydus Medical received FDA clearance 510(k) for a microvascular anastomosis suture deployment system for standardized omni-vessel anastomoses.
Category: Clearances
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FDA OKs Expanded Labeling of Preceptis Medical Tympanostomy Tube System
The U.S. FDA has granted Preceptis Medical expanded use indications for its Hummingbird Tympanostomy Tube System.
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FDA Clears Lazurite’s Wireless Camera for Minimally Invasive Surgery
The U.S. FDA has granted market clearance for Lazurite’s ArthroFree wireless camera system for minimally invasive surgery.
Clearances
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Lydus Medical Announces FDA Clearance of Microvascular Anastomosis Aid Device
Lydus Medical received FDA clearance 510(k) for a microvascular anastomosis suture deployment system for standardized omni-vessel anastomoses.
FDA Grants De Novo Clearance to Respiratory Device
ALung Technologies, Inc., a provider of low-flow extracorporeal carbon dioxide removal technologies for treating patients with acute respiratory failure, announces that the U.S. FDA has granted the company De Novo clearance for the Hemolung Respiratory Assist System.
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Fujifilm Launches Dual-Channel Endoscope
Fujifilm’s EI-740D/S is a dual-channel endoscope cleared by the U.S. FDA for use in both upper and lower gastrointestinal applications.
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FDA OKs ‘Major Advancement’ in CT Technology
The U.S. FDA says that it has granted 510(k) premarket clearance to what it deems the “first new major technological improvement for CT imaging in nearly a decade”—Siemens Healthineers’ Naeotom Alpha CT scanner.
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FDA OKs Siemens Healthineers CT Scanner
Malvern, Pa.-based Siemens Healthineers announces that the U.S. FDA has cleared SOMATOM X.ceed, a single-source CT scanner that combines high-speed scanning capabilities with a new hardware/software combination to streamline CT-guided interventions.
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FDA OKs Sterizo Tibial Revision Knee System, PS Plus Posterior Stabilized Tibial Insert
Richardson, Texas-based Fuse Medical, Inc. announces that it has received U.S. FDA 510(k) clearance for its Tibial Revision Knee System and the PS Plus Posterior Stabilized Tibial Insert, the latest additions to the Sterizo Total Knee System.
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Zimmer Biomet Nabs FDA Clearance for ROSA Hip System
Warsaw, Ind.-based Zimmer Biomet Holdings, Inc. announces that the U.S. FDA has granted 510(k) clearance to the ROSA Hip system for robotically assisted direct anterior total hip replacement.
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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.
