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

OUJ 2024-09-27

trophon Wireless Ultrasound Probe Holder

Applicant Nanosonics Limited

K-Number K241536

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HKY 2024-09-27

iCare ST500 (TA04)

Applicant Icare Finland OY

K-Number K241447

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GEX 2024-09-27

ACTIVO

Applicant Daeju Meditech Engineering Co., Ltd.

K-Number K242206

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OLX 2024-09-27

Sourcerer

Applicant Brain Electrophysiology Laboratory Company, LLC

K-Number K241513

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JAK 2024-09-27

CAC (gated) Algorithm

Applicant BunkerHill Health

K-Number K240369

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BTT 2024-09-27

Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula

Applicant Medline Industries, LP

K-Number K240163

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HCG 2024-09-27

Optima Coil System (OptiBlock Line Extension)

Applicant Balt USA, LLC

K-Number K242582

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FLL 2024-09-27

Aulisa Temperature Module (TM0002)

Applicant Taiwan Aulisa Medical Devices Technologies, Inc.

K-Number K240220

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HGX 2024-09-27

Elvie Stride 2

Applicant Chiaro Technology, Ltd.

K-Number K242125

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MWI 2024-09-27

AMC Health CareConsole

Applicant Amc Health

K-Number K233446

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BZD 2024-09-27

EasyCare Tx 2

Applicant Resmed Corp

K-Number K241939

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NFT 2024-09-27

AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K242540

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