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

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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QJP 2024-05-16

Wedge XL Delivery Catheter

Applicant MicroVention, Inc.

K-Number K232542

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PNN 2024-05-16

RAYDENT SW

Applicant Ray Co., Ltd.

K-Number K233625

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DQA 2024-05-16

Sempulse Halo Vital Signs Monitor

Applicant Sempulse Corporation

K-Number K232495

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FYC 2024-05-16

Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)

Applicant Owens & Minor (O&M) Halyard, Inc.

K-Number K232849

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IPF 2024-05-16

Stimulation System (PA series, PR series, S series and Q series)

Applicant Edan Instruments, Inc.

K-Number K232786

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GEX 2024-05-16

DEKA TORO

Applicant El.En S.P.A.

K-Number K240752

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