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

GXY 2025-01-02

Wave Electrode (AE02-60); Wave Electrode (AE02-50)

Applicant Bionit Labs Srl

K-Number K242326

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QIH 2025-01-02

Ezra Flash

Applicant Ezra Ai, Inc.

K-Number K242334

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DQA 2025-01-02

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)

Applicant Hunan Accurate Bio-Medical Technology Co., Ltd.

K-Number K243049

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MAX 2024-12-31

Idys® LIF

Applicant Clariance

K-Number K243670

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BZD 2024-12-31

Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)

Applicant Genadyne Biotechnologies, Inc.

K-Number K243225

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DQY 2024-12-31

MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)

Applicant ABBOTT MEDICAL

K-Number K243224

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BZH 2024-12-31

Peak Flow Meter

Applicant Chongqing Moffy Innovation Technology Co., Ltd.

K-Number K241338

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ITI 2024-12-31

Power Wheelchair (D10, D12, D15, D17, D20, D37)

Applicant Anhui Jbh Medical Apparatus Co., Ltd.

K-Number K242468

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BTA 2024-12-31

Nasal Aspirator (NS 13)

Applicant Avita Corporation

K-Number K241852

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ITI 2024-12-31

Electric Wheelchair (MODEL H)

Applicant Nanjing E-Take Medical Apparatus Co., Ltd.

K-Number K242989

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GEX 2024-12-30

Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)

Applicant Bios S.R.L.

K-Number K243445

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CBK 2024-12-30

AF531 Oro-Nasal SE Face Mask

Applicant Respironics, Inc.

K-Number K243394

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