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

FXX 2022-03-25

3 Ply Medical Grade Single Use Procedural Disposable Face Mask

Applicant Kdi Med Supply

K-Number K220637

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MAX 2022-03-25

Toro-L Interbody Fusion System

Applicant Integrity Implants, Inc.

K-Number K213355

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BZD 2022-03-25

Luna G3 BPAP System

Applicant 3B Medical, Inc.

K-Number K212263

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QEW 2022-03-25

Artix Thrombectomy Device

Applicant Inari Medical

K-Number K220600

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FXX 2022-03-25

Medical Surgical Mask (Model: JM92, JM92B)

Applicant Guangdong Jia Mei Biological Technology Co.Ltd

K-Number K220187

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DPS 2022-03-25

LE-12CH

Applicant Caf Medical Solutions, Inc.

K-Number K220362

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IYN 2022-03-25

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K220242

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LZA 2022-03-25

Medical nitrile examination gloves (Model: JL001)

Applicant Guangdong Jiali Pharmaceutical Co.,Ltd

K-Number K213848

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PGY 2022-03-25

C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor

Applicant Nanjing Jusha Display Technology Co., Ltd.

K-Number K212231

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CAF 2022-03-25

Nebulizer

Applicant Shenzhen Homed Medical Device Co., Ltd.

K-Number K212395

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FOZ 2022-03-25

Pluski Safe 1 Safety IV Catheter

Applicant Mediplus (India) Limited

K-Number K210037

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KWQ 2022-03-25

BALTEUM - ONE™ Lumbar Plate System

Applicant Huvexel Co. , Ltd.

K-Number K213820

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