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

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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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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QIH 2024-02-23

Overjet Charting Assist

Applicant Overjet, Inc.

K-Number K233590

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EIH 2024-02-23

rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono

Applicant Genoss Co., Ltd.

K-Number K232174

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DTR 2024-02-23

MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated

Applicant Medtronic

K-Number K240190

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BZH 2024-02-23

Electronic Peak Flow Meter

Applicant Taian Dalu Medical Instrument Co., Ltd.

K-Number K230423

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NUH 2024-02-23

ENSO (Model 2)

Applicant Hinge Health, Inc.

K-Number K233784

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