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

HGX 2023-03-16

MilkMate Breast Pump

Applicant Milkmate Products, Inc.

K-Number K223084

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NAY 2023-03-16

EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System

Applicant Intuitive Surgical, Inc.

K-Number K222839

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LZO 2023-03-16

BENCOX Delta Option Heads

Applicant Corentec Co., Ltd.

K-Number K223828

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ITI 2023-03-16

Electric Wheelchair

Applicant Shanghai Bangbang Robotics Co., Ltd.

K-Number K223393

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LZA 2023-03-16

Nitrile Examination Gloves

Applicant Ecoglove Medical Manufacturing Company Limited

K-Number K222813

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FRO 2023-03-16

Sterile Silver Alginate Wound Dressing

Applicant Qingdao Bright Moon Biomedical Materials Co., Ltd.

K-Number K220673

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NXC 2023-03-16

Ensmile

Applicant Ensmile Pvt, Ltd.

K-Number K222619

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LZA 2023-03-15

Tegamen Nitrile Examination Gloves

Applicant M/S Tegamen Safety Products Private Limited

K-Number K223102

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LZA 2023-03-15

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.

Applicant Kossan International Sdn Bhd3

K-Number K223375

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OHS 2023-03-15

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)

Applicant Light Tree Ventures Europe B.V.

K-Number K230124

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HKI 2023-03-15

iExaminer System with Panoptic Plus

Applicant Welch Allyn, Inc.

K-Number K223381

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IRP 2023-03-15

Air Compression Leg Massager (model: EMK-701)

Applicant Xiamen Emoka Health Science & Technology Co., Ltd.

K-Number K222991

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