Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

HQF 2026-02-06

INTEGRE LIO

Applicant Quantel Medical

K-Number K251507

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LNH 2026-02-05

SIGNA™ Sprint Select

Applicant Ge Medical Systems, LLC

K-Number K253779

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QBC 2026-02-05

Encora X1

Applicant Encora, Inc.

K-Number K251517

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OAS 2026-02-05

Primevision 3D

Applicant Dentsply Sirona

K-Number K253959

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QEW 2026-02-05

INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK

Applicant Penumbra, Inc.

K-Number K251949

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QEW 2026-02-05

CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister

Applicant Argon Medical Devices, Inc.

K-Number K260028

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FYA 2026-02-04

Henan Yadu Level 4 Surgical Gowns (Reinforced)

Applicant Yadu Medical (Henan) Co., Ltd.

K-Number K252301

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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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