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

QJN 2023-02-09

ETHICON LINX® Esophagus Sizing Tool

Applicant Torax Medical, Inc.

K-Number K230089

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FMF 2023-02-09

Sterile Syringes for Single Use

Applicant Shanghai Kindly Enterprise Development Group Co., Ltd.

K-Number K223678

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LZA 2023-02-09

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)

Applicant Nephron Pharmaceuticals Corporation

K-Number K223559

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OMP 2023-02-09

extriCARE® 3000 Negative Wound Pressure Therapy System

Applicant Alleva Medical Devices

K-Number K221223

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LON 2023-02-09

VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)

Applicant bioMerieux, Inc.

K-Number K222073

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JXG 2023-02-09

External Drainage System

Applicant Jmed(Shenzhen) Technology Limited

K-Number K221694

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NXC 2023-02-09

Toothsi, Smilealigners

Applicant Makeo Healthcare Technologies Private Limited

K-Number K223338

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FYC 2023-02-08

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)

Applicant Xiamen Probtain Medical Technology Co., Ltd.

K-Number K223304

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CAF 2023-02-08

Hailie Sensor NF0110

Applicant Adherium (Nz), Ltd.

K-Number K222247

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CAH 2023-02-08

Filter and HME/Filter

Applicant Ningbo Huakun Medical Equipment Co., Ltd.

K-Number K221472

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CGR 2023-02-08

Access Cortisol

Applicant Beckman Coulter, Inc.

K-Number K223038

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OHS 2023-02-08

NIRA Model 2

Applicant Dermal Photonics Corp

K-Number K222685

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