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

KGN 2022-09-20

LUOFUCON Collagen Wound Dressing

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K213598

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HWC 2022-09-20

Tandry Compression Screw System

Applicant Microware Precision Co., Ltd.

K-Number K220359

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FYA 2022-09-20

Disposable Surgical Gown UM-148

Applicant Unimax Medical Products Co., Ltd.

K-Number K221717

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FLE 2022-09-20

Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120

Applicant Tuttnauer , Ltd.

K-Number K221227

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FXX 2022-09-20

Surgical Face Mask (Non-sterile)

Applicant Xiantao Junhui Plastic Products Co., Ltd.

K-Number K221976

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QJP 2022-09-20

Millipede 088 Access Catheter

Applicant Perfuze, Ltd.

K-Number K214048

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MYN 2022-09-20

Aorta-CAD

Applicant Imagen Technologies, Inc.

K-Number K213353

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LZA 2022-09-20

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)

Applicant Mezorrison Medical Technology (Dongying) Co., Ltd.

K-Number K214056

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LZA 2022-09-20

Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)

Applicant Inner Mongolia Cureguard Medical Technology Co., Ltd.

K-Number K222642

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DZE 2022-09-19

NB 1 SA Implant System

Applicant Arum Dentistry Co., Ltd.

K-Number K222131

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QNQ 2022-09-19

Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe

Applicant Jeil Tech Co., Ltd.

K-Number K213013

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HWC 2022-09-19

Arthrex Compression FT Pins

Applicant Arthrex, Inc.

K-Number K220839

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