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

FDF 2024-02-16

Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K232043

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DSH 2024-02-16

S-Patch (S-Patch ExL)

Applicant Wellysis Corp.

K-Number K233906

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KWT 2024-02-16

AGILON® XO Shoulder Replacement System

Applicant Implantcast GmbH

K-Number K231657

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JHX 2024-02-16

Access CK-MB

Applicant Beckman Coulter, Inc.

K-Number K234005

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NPL 2024-02-16

Oral Matrix

Applicant Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

K-Number K231513

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FRA 2024-02-16

Airgle Room Air Purifier

Applicant Airgle Corporation

K-Number K232645

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ETD 2024-02-16

Biowy Tym Tube (TT)

Applicant Biowy Corporation

K-Number K233658

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DYB 2024-02-16

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)

Applicant Synaptic Medical Corporation

K-Number K233708

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OWB 2024-02-16

Zenition 30

Applicant Philips Medical Systems Nederland B.V.

K-Number K232420

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CAH 2024-02-15

Breathing circuit bacterial/viral filter

Applicant Shaoxing Haitech Medical Products Co., Ltd.

K-Number K222917

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FGE 2024-02-15

VedDilator ^TM (3-Stage Balloon Dilation Catheter)

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

K-Number K232245

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LPH 2024-02-15

EMPHASYS Dual Mobility System

Applicant Depuy Ireland UC

K-Number K231522

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