Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

OVE 2026-02-04

E3D-C Interbody System

Applicant Evolution Spine

K-Number K260038

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MAX 2026-02-04

Luna® Ti Interbody Fusion System

Applicant Spinal Elements, Inc.

K-Number K250773

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QHE 2026-02-04

Signature ONE System

Applicant Orthosoft Inc. (d/b/a) Zimmer CAS

K-Number K260104

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PNO 2026-02-04

UltraScore Focused Force PTA Balloon

Applicant Bard Peripheral Vascular, Inc.

K-Number K260012

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LPH 2026-02-04

G7® Revision Acetabular System

Applicant Zimmer, Inc.

K-Number K252623

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QVS 2026-02-03

Explant Express

Applicant Applied Medical Technology, Inc.

K-Number K252438

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QJI 2026-02-03

SmartGuard Technology; Predictive Low Glucose Technology

Applicant Medtronic Minimed

K-Number K253701

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HSB 2026-02-03

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System

Applicant Stryker GmbH

K-Number K253640

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QBJ 2026-02-03

Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System

Applicant Dexcom, Inc.

K-Number K253737

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DRT 2026-02-03

The Circadia C300 System (C300)

Applicant Circadia Health, Inc.

K-Number K252676

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OLO 2026-02-03

Navigation Module of the Cortium® System

Applicant Ulrich Medical USA, Inc.

K-Number K252087

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EHD 2026-02-03

Diagnostic X-Ray Equipment Model POCT22

Applicant Ningbo Runyes Medical Instrument Co., Ltd.

K-Number K252909

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