Search results for Fda 510(K) Clearance

Orthopedic Driven Imaging Announces FDA 510(k) Clearance for HipGuide™ — Its First FDA-Cleared Surgical Imaging App

FX Shoulder Solutions, Inc. Receives FDA 510(k) Clearance for FX V135® Easytech Shoulder System

NovoSource Receives FDA Clearance for SteriKneeâ„¢ Single-Use Total Knee Instrument System

FX Shoulder Solutions, Inc. Receives FDA 510(k) Clearance for FX V135® Easytech Shoulder System

The Next Generation of Stemless Has Arrived ADDISON, Texas, May 5, 2026 /PRNewswire/ — FX Shoulder Solutions, Inc. has received…

Avatar Medical Receives FDA 510(k) Clearance for Avatar Medical Vision, the First Software Cleared for Use with Glasses-...

Pixee Medical Announces FDA 510(k) Clearance for Its Next-generation Solution, Knee+ NexSight, on a New Augmented Realit...

Protaryx Receives FDA Approval for Transseptal Puncture Device

Protaryx Medical, a Maryland-based company dedicated to “minimally invasive left-heart interventional therapies,” announced that its Transseptal Puncture Device received 510(k) cle...

Allevion Medical™ Receives 510K Clearance for Vantage™— A Fully Disposable Kit Featuring a Novel Approach to Spina...

BOCA RATON, Fla., April 3, 2026 -(BUSINESS WIRE)- Allevion Medical today announced the FDA clearance of Vantage™, a…

SurGenTec Secures FDA 510(k) Clearance for TiLinkв„ў SI joint fusion- Now Navigation Compatible

FDA Grants 510(k) Clearance for Glooko’s EndoTool IV Cloud Insulin Dosing Platform

What You Should Know Glooko has received U.S. FDA 510(k) clearance for EndoTool IV Cloud, making it the first cloud-based, patient-specific insulin dosing platform cleared for hosp...

Zeto’s latest EEG device garners FDA 510(k) clearance for outpatient use

Zeto, which makes brainwave monitors for emergency rooms, received a third FDA clearance for an EEG device. The latest is intended for use in outpatient clinics or at home.

Kreate Medical Announces Two FDA 510(k) Clearances, Introducing Antibacterial Absorbable Synthetic Matrix for Wound Mana...

Kreate Medical has received two FDA 510(k) clearances for its innovative wound matrix products, including Antibacterial Absorbable Synthetic Matrix and Absorbable Synthetic Matrix....

GE HealthCare Receives FDA Clearance for True Definition DL CT Image Reconstruction Technology

What You Should Know The Regulatory Win: GE HealthCare has received 510(k) clearance from the FDA for True Definition DL, the latest addition to its portfolio of deep learning (DL)...

LINCOTEK SECURES FDA 510(K) CLEARANCE FOR SPORTLINCâ„¢

SpineCraft Announces U.S. FDA 510(k) Clearance of Comprehensive ORIO-3D Trabecular Interbody Platform

FDA-cleared. Quietly adopted. Nationally ready. KeyLiftâ„¢ is about to get loud.

SurGenTec Secures FDA Clearance for ION-C™ – Now Navigation Compatible

SurGenTec, LLC today announced that the FDA has granted 510(k) clearance for its ION-Câ„¢ navigation instruments for use with the ION-Câ„¢ posterior cervical facet fixation implant...

FDA Approves Expanded Clinical Applications for SINEFIXâ„¢ in Soft Tissue Repair

Pixee Medical Announces FDA 510(k) Clearance for Its Next-generation Solution, Knee+ NexSight, on a New Augmented Realit...

BESANÇON, France, April 27, 2026 -(BUSINESS WIRE)- Pixee Medical, a pioneer in Augmented Reality (AR) navigation for orthopedic…

Zimmer Biomet Receives FDA Clearance for Expanded Reverse Shoulder Systems

Biodynamik Receives FDA IDE Approval for Pivotal U.S. Trial of XT3 System in Diabetic Foot Ulcers

Spectrum Spine Inc Earns FDA Clearance for Next Generation Nanotechnology – BioBraille™

SurGenTec Secures FDA 510(k) Clearance for TiLinkâ„¢ SI joint fusion- Now Navigation Compatible

BOCA RATON, Fla., April 15, 2026 -(BUSINESS WIRE)- SurGenTec, LLC, a leader in innovative spine and orthopedic technologies,…

CMS, FDA announce pathway to expedite access to certain medical devices for Medicare beneficiaries

The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to expedite access to certain FDA-designated Class II and...