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

MUJ 2024-05-17

Radiance V5

Applicant Gmv Soluciones Globales Internet S.A.U.

K-Number K233236

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LKD 2024-05-17

Sentec Digital Monitoring System (SDMS) tCOM+

Applicant Sentec AG

K-Number K232516

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OBO 2024-05-17

CIRRUS™ HD-OCT Model 6000

Applicant Carl Zeiss Meditec, Inc.

K-Number K233933

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ONF 2024-05-17

Intense Pulsed Light System (ST-690)

Applicant Smedtrum Medical Technology Co., Ltd.

K-Number K240482

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DRC 2024-05-17

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)

Applicant Pressure Products Medical Device Manufacturing, LLC

K-Number K241042

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QIH 2024-05-17

uOmnispace.CT

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K233209

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KNT 2024-05-16

ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)

Applicant Reshape Lifesciences

K-Number K241039

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ONF 2024-05-16

DEKA LOTUS

Applicant El.En S.P.A.

K-Number K233473

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GEX 2024-05-16

Picosecond Nd:YAG Laser Systems (BL-C10)

Applicant Shanghai Bele Medical Technology Co.,Ltd

K-Number K240386

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QNO 2024-05-16

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

Applicant Signifier Medical Technologies, Ltd.

K-Number K240328

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NGX 2024-05-16

Pain Therapy Device(Model: P.T.S-X)

Applicant Guangzhou Xinbo Electronic Co., Ltd.

K-Number K230711

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FRA 2024-05-16

AirKEE P900

Applicant Healkee Medical Pte, Ltd.

K-Number K232933

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