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

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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JAQ 2024-10-29

Catheter Surface Flap Applicator Set (GM11011830)

Applicant Varian Medical Systems

K-Number K241965

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ITI 2024-10-29

Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02)

Applicant Jiaxing Xiaoxiang Medical Equipment Technology Co., Ltd.

K-Number K241189

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MBI 2024-10-29

OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor

Applicant Riverpoint Medical

K-Number K243203

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EOQ 2024-10-29

Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)

Applicant Hunan Vathin Medical Instrument Co., Ltd.

K-Number K241612

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