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

QNP 2024-04-19

SKOUT® system

Applicant Iterative Scopes, Inc.

K-Number K240781

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OVE 2024-04-19

UniSpace® Stand-Alone C Cage

Applicant Innosys Co., Ltd.

K-Number K234119

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MPD 2024-04-19

LIFEPAK® 35 AC Power Adapter (41335-000001)

Applicant Stryker Physio-Control

K-Number K240162

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KGN 2024-04-19

ReyaGel (RG03 - MTP gel 3mL)

Applicant Fettech

K-Number K232204

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QEW 2024-04-19

ICE Aspiration System

Applicant Expanse Medical, Inc.

K-Number K234073

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OUR 2024-04-19

Patriot-SI Posterior Implant System

Applicant Spinal Simplicity, LLC

K-Number K232259

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LFD 2024-04-19

Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)

Applicant Laclede, Inc.

K-Number K240508

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MUH 2024-04-18

RAYSCAN a-Expert

Applicant Ray Co., Ltd.

K-Number K232325

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LRK 2024-04-18

Difiney Anti Snoring Device

Applicant Fissiontech, LLC

K-Number K233850

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INI 2024-04-18

Mobility Scooter (C4+)

Applicant Yongkang Yile Vehicle Co., Ltd.

K-Number K234098

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PFO 2024-04-18

Cochlear Osia System

Applicant Cochlear Americas

K-Number K240155

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OMP 2024-04-18

Prospera Spectruum Negative Pressure Wound Therapy System

Applicant Deroyal Industries, Inc.

K-Number K230233

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