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

NPL 2024-05-01

Soft Tissue Augmentation Resorbable Matrix

Applicant Collagen Matrix, Inc.

K-Number K233203

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LHI 2024-05-01

Vial Adapter with Filter

Applicant Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

K-Number K233284

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OLO 2024-05-01

Remex Spine Surgery Navigation System II

Applicant Remex Medical Corp.

K-Number K233513

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GEX 2024-05-01

ORskin Blue

Applicant Megabay S.A.

K-Number K232858

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QAT 2024-05-01

VIDAS TBI (GFAP, UCH-L1)

Applicant bioMerieux, Inc.

K-Number K240279

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NBL 2024-05-01

SmarTooth

Applicant Smartooth Co., Ltd.

K-Number K231722

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HKY 2024-05-01

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)

Applicant Reichert, Inc.

K-Number K233516

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FGA 2024-05-01

Percutaneous Nephroscope System

Applicant Karl Storz SE & CO. KG

K-Number K232370

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DXF 2024-05-01

HOTWIRE™ RF Guidewire

Applicant Atraverse Medical

K-Number K240900

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EOQ 2024-05-01

MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box

Applicant Medimaging Integrated Solution, Inc (Miis)

K-Number K234113

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IRP 2024-05-01

Cold Compression

Applicant Jkh Health Co., Ltd.

K-Number K240986

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DYB 2024-05-01

AuST Steerable Sheath

Applicant CenterPoint Systems, LLC

K-Number K240829

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