Social Media Ideas for Fda (510)K Clearance

New Diagnostic Radiology Viewer Achieves FDA 510(k) Clearance, Setting Industry Benchmark

Candelis, Inc. has earned FDA 510(k) clearance for its ImageGrid StreamVue Enterprise platform, positioning the streaming-based software among the top-rated diagnostic radiology vi...

Shoulder Innovations Receives FDA 510(k) Clearance for N-22 Humeral Head and Initiates Full Commercial Launch

Second Product Introduction on New Line of Technologies for Metal-Sensitive Patients GRAND RAPIDS, Mich., Sept. 10, 2026 /PRNewswire/ — Shoulder…

Why FDA Clearance Alone Can’t Guarantee Medical Device Success

Why FDA Clearance Alone Can’t Guarantee Medical Device Success Anonymous (not verified) Thu, 10/15/2026 - 10:12 pharmagather item url Why FDA Clearance Alo...

Natural design. Amplified: Smith+Nephew announces FDA 510(k) clearance and first surgical case of LANDMARKâ—Š Total Knee...

Smith+Nephew today announces it received 510(k) clearance from the FDA and has completed the first surgical case with LANDMARK Total Knee System

FDA grants 510(k) clearance for BoneEnhance, the first machine learning layer on RIVANNA’s Accuro XV platform

Anatomy segmentation and three-dimensional skeletal visualization arrive with this clearance; an injury detection module for clinical decision support…

Natural design. Amplified: Smith+Nephew announces FDA 510(k) clearance and first surgical case of LANDMARKâ—Š Total Knee...

September 22, 2026 – Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it received 510(k) clearance…

Shoulder Innovations Receives FDA 510(k) Clearance for N-22 Humeral Head and Initiates Full Commercial Launch

Second product introduction on new line of technologies for metal-sensitive patients.

Pace Surgical Receives FDA 510(k) Clearance for the Tempoв„ў Variable Locking Plating System

The cleared system on display at the AOFAS Annual Meeting in Seattle; full commercial launch planned for early 2027 following completion of manufacturing.

SI-BONE Receives FDA 510(k) Clearance for iFuse Granite Onyxâ„¢, Extending Its Compromised Bone Franchise Beyond the Pel...

SI-BONE, Inc. announced FDA 510(k) clearance for the iFuse Granite Onyx System (Onyx).

SI-BONE Receives FDA 510(k) Clearance for iFuse Granite Onyxâ„¢ Extending Its Compromised Bone Franchise Beyond the Pelv...

FDA Breakthrough Device Designated (BDD) platform engineered for durable fixation in low density bone SANTA CLARA, Calif., Sept.…

TELA Bio Announces 510(k) Clearance for Liora™ Monofilament Scaffold for Soft Tissue Reinforcement

MALVERN, Pa., Oct. 05, 2026 (GLOBE NEWSWIRE) — TELA Bio, Inc. (“TELA Bio” or the “Company”), a commercial-stage…

Xenix Medical Announces FDA Clearance of NanoACTIV™ Surface Technology for Its Riva® Posterior Fixation System

ORLANDO, Fla., October 1, 2026 -(BUSINESS WIRE)- Xenix Medical today announced FDA 510(k) clearance for the addition of…

Xenix Medical Announces FDA Clearance of NanoACTIV™ Surface Technology for Its Riva® Posterior Fixation System

Xenix Medical today announced FDA 510(k) clearance for the addition of NanoACTIV Surface Technology to the screw shanks of its Riva modular pedicle screw system.

Innovasis Receives FDA Clearance for Nano-Scale Surface Designation on AxTiHA, TxTiHA, and HAtetracell-C Implants

Engineered 20-nanometer surface architecture on Innovasis' HA-coated titanium implants was reviewed and cleared under the FDA's Nanotechnology Guidance, confirming nanoscale surfac...

Putting Pain on Ice: FDA Opens a New Chapter in Injectable Nerve Treatment

A truly novel treatment for pain associated with knee osteoarthritis was just granted its own, entirely new 510(k) device category.

Coreline Soft Receives U.S. FDA 510(k) Clearance for AVIEW Aorta Metrics, Expanding Its Chest CT AI Portfolio in the U.S...

SEOUL, South Korea and CHICAGO, Oct. 23, 2026 /PRNewswire/ — Coreline Soft has received U.S. Food and Drug Administration (FDA)…

ArthroTAK Receives FDA 510(k) Clearance for Expanded Indications, Extending Sutureless Fixation Platform Across the Body

ArthroTAK, LLC has received FDA 510(k) clearance for expanded indications, extending the ArthroTAK® platform beyond its original shoulder applications into new areas of the body, i...

MRI2CT Receives FDA 510(k) Clearance for NextMR, Enabling 3D Bone Visualization from Standard Spine MRI

FDA clearance advances MRI-only spine workflows using the patient’s standard diagnostic MRI.

Spineart and eCential Robotics receive FDA 510(k) clearance for the PERLA® TL application for use with eCential® Op.n® n...

GENEVA, Aug. 26, 2026 /PRNewswire/ — Spineart, a global fast-growing company in spine surgery innovation, and eCential Robotics today announced…

Medtronic announces FDA clearance for LigaSureâ„¢ RAS Maryland instrument on the Hugoâ„¢ RAS system

GALWAY, Ireland, Sept. 16, 2026 /PRNewswire/ — Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and…

FDA Medical Devices: Important Regulatory Considerations for Companies Seeking to Enter the U.S. Market

The medical device market in the U.S. is very large and attractive to many companies who are located outside of the U.S. Entering the U.S. medical device market requires a comprehe...

Bioretec receives FDA 510(k) clearance for its ActivaScrewâ„¢ Cannulated COM bioabsorbable compression screw

RingConn smart ring receives FDA clearance for blood oxygen monitoring

Shenzhen-based wearable technology company RingConn has received US Food and Drug Administration (FDA) 510(k) clearance for non-invasive blood oxygen (SpO2) measurement on its Smar...

Medtronic announces FDA clearance for LigaSureв„ў RAS Maryland instrument on the Hugoв„ў RAS system

Medtronic announced the FDA has cleared the LigaSureв„ў RAS Maryland jaw device for use with the Hugoв„ў robotic-assisted surgery (RAS) system.