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

CCL 2023-04-01

Maxtec MaxO2 ME+p

Applicant Maxtec, LLC

K-Number K221734

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GEX 2023-03-31

Medical Diode Laser (M2)

Applicant Wuhan Pioon Technology Co., Ltd.

K-Number K230274

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QEW 2023-03-31

ROVO Mechanical Thrombectomy Device

Applicant 2mg, Inc.

K-Number K220780

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IYE 2023-03-31

Iris AirShuttle

Applicant Qfix

K-Number K230312

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QVT 2023-03-31

Masimo SafetyNet

Applicant Masimo Corporation

K-Number DEN200011

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OHT 2023-03-31

IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32

Applicant Shenzhen Yangyi Technology ., Ltd.

K-Number K230021

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GCJ 2023-03-31

1788 4K Camera System with Advanced Imaging Modality

Applicant Stryker

K-Number K230605

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IYO 2023-03-31

Butterfly iQ/iQ+ Ultrasound System

Applicant Butterfly Network, Inc.

K-Number K220068

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DJG 2023-03-31

BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx

Applicant Shenzhen Bioeasy Biotechnology Co., Ltd.

K-Number K230238

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FRN 2023-03-31

Spectrum IQ Infusion System with Dose IQ Safety Software

Applicant Baxter Healthcare Corporation

K-Number K230041

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QEW 2023-03-31

Aspirex Thrombectomy System

Applicant C.R. Bard, Inc.

K-Number K230356

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IYN 2023-03-31

SonoAir Series Digital Color Doppler Ultrasound System

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K223570

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