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

NKB 2026-09-23

iFuse Granite Onyx™ Implant System

Applicant SI-BONE, Inc.

K-Number K262067

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HWC 2026-09-23

DynaNail Helix® Fixation System

Applicant MedShape, Inc.

K-Number K260995

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NUC 2026-09-23

Everslide

Applicant Special Situations, LLC

K-Number K260117

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EOQ 2026-09-23

Single-use Flexible Bronchoscope

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K261637

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LLZ 2026-09-23

Syneris PACS v.1.0.1.0

Applicant Syneris

K-Number K261874

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QOK 2026-09-22

Echo-2

Applicant Neko Health AB

K-Number K254240

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JHI 2026-09-22

Instant-View® hCG Combo II Cassette Test

Applicant Alfa Scientific Designs, Inc.

K-Number K262299

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QOF 2026-09-22

BIOFIRE Respiratory Panel 2.1 (RP2.1)

Applicant Biofire Diagnostics

K-Number K263054

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PBX 2026-09-22

Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)

Applicant Bh Group Us, LLC

K-Number K243223

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FRO 2026-09-22

Actolind® (06.3637. Actolind® Gel Plus)

Applicant ACTO GmbH

K-Number K254168

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QIH 2026-09-22

BoneXpert

Applicant Visiana

K-Number K262390

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IOR 2026-09-22

ErgoSteel (ES0001/696)

Applicant Strongback Mobility AG C/O Blueaudit GmbH

K-Number K253762

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