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

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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QJP 2024-12-30

Next Generation Access Platform

Applicant Balt USA, LLC

K-Number K242376

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QPB 2024-12-30

PAL Aspiration System

Applicant Microaire Surgical Instruments, LLC

K-Number K242804

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