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

OLR 2025-01-03

Elemental Granulate

Applicant Zinkh NV

K-Number K241283

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LLZ 2025-01-03

Clarify DL

Applicant Ge Medical Systems Israel, Functional Imaging

K-Number K241350

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GEI 2025-01-03

Inbella RF System

Applicant Inbella Medical, Inc.

K-Number K243737

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DZL 2025-01-03

GBR System

Applicant Proimtech Saglik Urunleri Anonim Sirketi

K-Number K233419

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DYH 2025-01-03

Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive

Applicant Ormco Corporation

K-Number K250015

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KPR 2025-01-03

INNOVISION-EXII

Applicant Dk Medical System

K-Number K242119

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QIH 2025-01-02

Ortho AI

Applicant Ortho Ai, LLC

K-Number K241696

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QJP 2025-01-02

Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K241388

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ITI 2025-01-02

Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)

Applicant Anhui Jbh Medical Apparatus Co., Ltd.

K-Number K242448

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PKL 2025-01-02

Haemostasis Clips

Applicant Jiangxi Zhuoruihua Medical Instrument Co., Ltd.

K-Number K241005

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LBH 2025-01-02

CrystLCare PRO Biorestorative, Fluoride-Plus

Applicant GreenMark Biomedical, Inc.

K-Number K241568

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OHS 2025-01-02

Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)

Applicant Dongguan Laiguang Electronic Technology Co., Ltd.

K-Number K242789

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