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Winter Innovations Receives FDA 510(k) Clearance and PCCP Authorization for Expanded EasyWhip® Family

Winter Innovations announced that the FDA has granted 510(k) clearance for the expanded EasyWhip® Family, along with authorization of a Predetermined Change Control Plan (PCCP) cov...

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

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

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

NovoSource announced that it has received FDA 510(k) clearance for SteriKneeâ„¢, a sterile, pre-assembled, single-use instrument system designed for use with the NovoKnee Total Kne...

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

Orthopedic Driven Imaging (ODI) announced that HipGuideâ„¢, its intraoperative surgical imaging software application, has received 510(k) clearance from the FDA.

OrthAlign, Inc. Receives FDA 510(k) clearance for the LanternВ® ASC system

IRVINE, Calif.,В June 3, 2026В /PRNewswire/ —В OrthAlign, Inc., the pioneer of handheld orthopedic navigation, today announced FDA 510(k) clearance for…

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...

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....

Onkos Surgical® Receives FDA 510(k) Clearance for Application of NanoCept® Antibacterial Technology to Titanium Implan...

PARSIPPANY, N.J., June 9, 2026 /PRNewswire/ — Onkos Surgical, a leader in innovative solutions for musculoskeletal oncology and complex orthopaedic…

Next-Generation AI-Driven SyncAR® Spine Receives FDA Clearance for Spine Surgery

CLEVELAND, Oct. 10, 2025 /PRNewswire/ — Surgical Theater, the leader in surgical XR visualization, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for Sync...

Onkos Surgical® Receives FDA 510(k) Clearance for Application of NanoCept® Antibacterial Technology to Titanium Implan...

Onkos Surgical announced it has received clearance from theFDA for the application of its NanoCept Antibacterial Technology on titanium implants within the ELEOS Limb Salvage Syste...

SDIP Innovations Announces FDA 510(k) Clearance of JAZBIв„ў Bone Void Filler, Marking the First Commercial Application o...

SDIP Innovations Pty Ltd, an Australian biomaterials company focused on regenerative technologies for musculoskeletal applications, announced that the FDA has granted 510(k) cleara...

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 Clears OrthAlign’s ASC – Friendly Knee Navigation

OrthAlign’s portable large joint navigation system is now FDA cleared for ambulatory surgery centers.

SurGenTec Secures FDA Clearance for ION-Cв„ў – Now Navigation Compatible

SurGenTec Announces FDA Clearance of ION-Cв„ў Navigation for Real-Time Guidance in Posterior Cervical Facet Procedures BOCA RATON, Fla.,…

SurGenTec® Receives FDA Clearance for ION-L™, a Novel Lumbar Facet Fixation System Representing a Paradigm Shift in M...

SurGenTec® today announced FDA clearance of its ION-L™ Lumbar Facet Fixation System. ION-L™, indicated for the treatment of patients with (DDD) from L3 to S1 in skeletally mat...

Solenic MedicalВ® Receives FDA IDE Approval to Initiate Pivotal Trial of SOLA-2в„ў for Periprosthetic Joint Infections

Solenic Medical today announced that the FDA has approved the its IDE application, authorizing the launch of a pivotal clinical trial for its SOLA-2в„ў Alternating Magnetic Field S...

HepQuant nabs FDA premarket approval for liver diagnostic test

The FDA has granted premarket approval to HepQuant’s liver diagnostic test for the treatment of adults with Child-Pugh Class A compensated cirrhosis, according to a company press r...

SpineCraft Announces U.S. FDA 510(k) Clearance of ANTERIS Thoracolumbar Plate System

Westmont, Illinois, May 18, 2026, / OrthoSpineNews / – SpineCraft, a U.S.-based spine surgery systems developer and manufacturer,…

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...

Penumbra’s THUNDERBOLT Receives FDA Clearance – Bringing Computer Assisted Vacuum Thrombectomy Technology to Stroke

THUNDERBOLT is the first CAVT platform to deliver modulated aspiration for acute ischemic stroke — enabling faster, more…

IHealthScreen nabs FDA nod for AI-backed dx to spot mild diabetic retinopathy

IHealthScreen hauled in FDA 510(k) clearance for its AI-powered diagnostic that detects mild diabetic retinopathy in diabetic adults who have gone undiagnosed with the condition.

FDA Issues Draft Guidance Clarifying Use of Form FDA 3542

Conexeu Sciences: Hanging On The FDA 510(k) Pathway Submission