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

QNP 2024-07-03

SKOUT® system

Applicant Iterative Scopes, Inc.

K-Number K241508

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JWJ 2024-07-03

Total Wrist Arthroplasty System (TWA)

Applicant Skeletal Dynamics

K-Number K233574

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IZL 2024-07-03

iQFlex Pro

Applicant First Source, Inc.

K-Number K240009

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PIF 2024-07-03

Disposable Enteral Feeding Sets

Applicant Beijing L&Z Medical Technology Development Co., Ltd.

K-Number K240052

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NAY 2024-07-03

da Vinci Surgical System (IS5000)

Applicant Intuitive Surgical, Inc.

K-Number K241284

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DXN 2024-07-03

Upper Arm Electronic Blood Pressure Monitor

Applicant Shenzhen Goodlymed Technology Co., Ltd.

K-Number K241129

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JNL 2024-07-03

Access Thyroglobulin Antibody II

Applicant Beckman Coulter, Inc.

K-Number K240996

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ITX 2024-07-03

Transducer Probe Cover

Applicant Hony Medical Co., Ltd.

K-Number K241615

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DXE 2024-07-02

Fogarty Fortis Arterial Embolectomy Catheter

Applicant Edwards Lifesciences

K-Number K241330

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SAH 2024-07-02

MagDI System

Applicant Gt Metabolic Solutions, Inc.

K-Number DEN240013

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FXX 2024-07-02

FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)

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

K-Number K232824

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ELC 2024-07-02

Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)

Applicant Shenzhen Micro Electric Intelligence Co., Ltd.

K-Number K240707

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