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

FRO 2026-01-05

Puracyn® Plus Antimicrobial Irrigation Solution

Applicant Innovacyn, Inc.

K-Number K251757

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LTJ 2026-01-05

Atellica IM Total PSA II (tPSAII)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K251630

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EZD 2026-01-02

Ready to use Nelaton Catheter

Applicant Jamjoom Fullcare Corporation

K-Number K251178

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INI 2026-01-02

Mobility Scooter (BC-MS310)

Applicant Ningbo Baichen Medical Devices Co., Ltd.

K-Number K252817

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OWX 2026-01-02

FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit

Applicant ZuriMED Technologies AG

K-Number K253867

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GXP 2026-01-02

MONTAGE XT Cranial Cement

Applicant Orthocon, Inc.

K-Number K253854

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HWC 2025-12-31

Tyber Medical Trauma Screw

Applicant Tyber Medical, LLC

K-Number K252901

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NUH 2025-12-31

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

Applicant Shenzhen Jiantuo Electronics Co., Ltd.

K-Number K253305

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QJQ 2025-12-31

Genesis Sleep

Applicant Neurofield, Inc.

K-Number K252951

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NEU 2025-12-31

MOLLI 2 System

Applicant Stryker Endoscopy

K-Number K253888

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DXC 2025-12-31

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)

Applicant Arc Trauma, LLC

K-Number K243627

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CHH 2025-12-30

Lipids

Applicant Truvian Health

K-Number K251091

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