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

FBO 2024-11-27

KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)

Applicant Karl Storz SE & CO. KG

K-Number K243409

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OWW 2024-11-27

BioBrace®

Applicant Conmed Corporation

K-Number K242187

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KPI 2024-11-27

Pelvic Floor Stimulator (Intrelief PFE)

Applicant Easymed Instruments Co., Ltd.

K-Number K241899

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ITI 2024-11-27

Power wheelchair

Applicant Zhejiang Zhonglei Medical Technology Co. , Ltd.

K-Number K242308

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QAU 2024-11-27

Nexpowder

Applicant Nextbiomedical Co., Ltd.

K-Number K240994

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HTN 2024-11-27

TACTIX Vector Syndesmosis System

Applicant Vilex, LLC

K-Number K243408

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QJY 2024-11-27

Remunity System

Applicant Deka Research & Development Corp.

K-Number K243354

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IYN 2024-11-27

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K242444

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PGY 2024-11-27

RadiForce RX570; RadiForce RX570-AR

Applicant Eizo Corporation

K-Number K243221

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EBF 2024-11-27

C&B Ceramic; C&B Permanent; C&B Interim

Applicant Prevest Denpro Limited

K-Number K233273

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OHS 2024-11-27

LED Light Therapy Machine (G1, G3, G4, G6)

Applicant Shenzhen Walton Technology Co., Ltd.

K-Number K242638

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JFB 2024-11-27

Ceragem Automatic Thermal Massager (CGM-MB-1902)

Applicant Ceragem Co., Ltd.

K-Number K243355

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