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

OHS 2026-06-16

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K254025

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HSN 2026-06-16

Prophecy Incompass Surgical Planning System

Applicant Wright Medical Technology, Inc. (Stryker)

K-Number K253159

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NPM 2026-06-16

BOSS

Applicant Medpark Co., Ltd.

K-Number K253723

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NHA 2026-06-15

Neodent Scannable Healing Abutment

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K253922

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GXP 2026-06-15

Permatage XT Settable Bone Putty

Applicant Orthocon, Inc.

K-Number K261265

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DXN 2026-06-15

Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

Applicant Tournicare Pty, Ltd.

K-Number K253059

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OVE 2026-06-15

NeckTune™ 3D SA Cervical Cage

Applicant Medyssey Co, Ltd.

K-Number K260036

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QIH 2026-06-15

WatchMate Software

Applicant Anumana, Inc.

K-Number K260300

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KPR 2026-06-15

DRE Duo

Applicant Jpi Healthcare Co, Ltd.

K-Number K260482

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PGX 2026-06-15

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit

Applicant Diasorin Molecular, LLC

K-Number K260333

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QIH 2026-06-15

MediAI-OA

Applicant Crescom Co., Ltd.

K-Number K253172

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MQE 2026-06-15

Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K-Number K253121

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