Search results for 510K Clearance

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

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

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

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

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…

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

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...

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...

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....

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

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

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.

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

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

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...

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)...

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

<![CDATA[FDA Clears Investigational New Drug Application for Phase Ib/IIa Trial of CK0802 in Steroid-Refractory Graft...

Zimmer Biomet Receives FDA Clearance for Expanded Reverse Shoulder Systems

Avatar Medical Gains FDA 510(k) Clearance for 3D Medical Imaging Platform

What’s the story? Avatar Medical has gained FDA clearance for Avatar Medical Vision, its 3D medical image review and surgical planning platform. Why it matters The platform lets cl...

How to Select a Medical Device Camera for FDA 510(k) and CE-Regulated Embedded Vision Systems - Vadzo Imaging FALCON USB...

VElectrical safety class, EMC characterization, sensor architecture, and OEM compliance documentation are the variables that determine whether a medical device camera integration c...

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

KeyLift Implants Amplio Spine, LLC signs Letter of Intent to acquire the FDA–cleared KeyLift™ Expandable Interlaminar Stabilization System (K232484)…