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

OCT 2024-02-26

GOLFF Sterile Anti-Fog Solution

Applicant Batrik Medical Manufacturing, Inc.

K-Number K231822

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OLW 2024-02-26

BIS Advance Monitoring System

Applicant Covidien, LLC

K-Number K230693

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QBJ 2024-02-26

Dexcom G7 Continuous Glucose Monitoring System

Applicant Dexcom, Inc.

K-Number K234133

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GCA 2024-02-26

Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)

Applicant Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K-Number K232752

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NKB 2024-02-26

VADER® Pedicle System

Applicant Icotec AG

K-Number K232628

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HQC 2024-02-26

Stellaris Elite vision enhancement system

Applicant Bausch and Lomb

K-Number K232084

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PCC 2024-02-26

TENS device-HeadaTerm 2 (Model: YF-HT2)

Applicant Wat Medical Technology, Inc.

K-Number K230782

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HRX 2024-02-26

FMS VUE Fluid Management and Tissue Debridement System

Applicant DePuy Mitek, Inc.

K-Number K233675

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LZA 2024-02-26

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid

Applicant Eco Medi Glove Sdn. Bhd.

K-Number K233560

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SAB 2024-02-23

MIRA Surgical System

Applicant Virtual Incision

K-Number DEN230025

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LQZ 2024-02-23

AIO Breathe

Applicant Aiomega, LLC

K-Number K233754

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NBW 2024-02-23

CONTOUR® PLUS BLUE Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care

K-Number K231679

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