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

LLZ 2024-11-15

1CMR Pro

Applicant Mycardium AI Limited

K-Number K242062

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ELW 2024-11-15

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator

Applicant Dent4you AG

K-Number K242360

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MQB 2024-11-15

VIVIX-S 1751S

Applicant Vieworks Co., Ltd.

K-Number K241125

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LIT 2024-11-15

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

Applicant Creagh Medical Ltd. Dba Surmodics, Inc.

K-Number K242419

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SDJ 2024-11-15

EchoGo Amyloidosis (1.0)

Applicant Ultromics Limited

K-Number K240860

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GEI 2024-11-15

ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator

Applicant Livsmed, Inc.

K-Number K241138

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N/A 2024-11-15

CORIOGRAPH Pre-Op Planning and Modeling Services

Applicant Blue Belt Technologies, Inc.

K-Number K242272

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DSY 2024-11-15

Gelsoft™ Plus Vascular Prostheses

Applicant Vascutek, Ltd.

K-Number K241070

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ODP 2024-11-15

aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM

Applicant Carlsmed, Inc.

K-Number K242260

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CAH 2024-11-14

Besmed Bacterial Filter and HMEF

Applicant Besmed Health Business Corp

K-Number K241339

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MSX 2024-11-14

Hinscope

Applicant Hinlab Sas

K-Number K241397

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PBX 2024-11-14

DEFINE System (AG612444A)

Applicant InMode , Ltd.

K-Number K242598

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