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

FCX 2024-10-30

MedicCO2LON (MedicCO2LON)

Applicant Ide Vision, Ltd.

K-Number K240847

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DSI 2024-10-30

Zio AT® device (A100A1001)

Applicant iRhythm Technologies, Inc.

K-Number K240177

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DZE 2024-10-30

ZENEX Implant System_Long

Applicant Izenimplant Co., Ltd.

K-Number K240560

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FLL 2024-10-30

Wearable Digital Thermometer (T31)

Applicant Guangdong Genial Technology Co., Ltd.

K-Number K240333

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GCJ 2024-10-30

LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)

Applicant Lagis Enterprise Co., Ltd.

K-Number K240334

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QHH 2024-10-30

NeurAxis IB-Stim (01-1020)

Applicant Neuraxis

K-Number K241533

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QIH 2024-10-30

RemedyLogic AI MRI Lumbar Spine Reader

Applicant Remedy Logic, Inc.

K-Number K241108

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SBF 2024-10-30

Caduceus S

Applicant Taiwan Main Orthopaedic Biotechnology Co., Ltd.

K-Number K242271

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DKZ 2024-10-30

DRI Ecstasy Plus Assay

Applicant Microgenics Corporation

K-Number K240670

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KPS 2024-10-30

Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family

Applicant Siemens Medical Solutions USA, Inc.

K-Number K243186

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QGM 2024-10-30

Edison System

Applicant HistoSonics, Inc.

K-Number K241902

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PLO 2024-10-29

QIAstat-Dx Meningitis/Encephalitis (ME) Panel

Applicant QIAGEN GmbH

K-Number K242256

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