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

FMF 2023-10-06

Disposable Sterile Syringe

Applicant Weihai Shengjie Medical Technology Co., Ltd.

K-Number K221777

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LHI 2023-10-06

Vial Adapter

Applicant Shanghai Lingfu Technology Co., Ltd.

K-Number K232055

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PZS 2023-10-06

ProtekDuo Veno-Venous Cannula Sets

Applicant Cardiacassist, Inc.

K-Number K232480

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PNR 2023-10-06

Nutricair Enteral Syringe with ENFit

Applicant Cair Lgl

K-Number K231300

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DSI 2023-10-06

MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

Applicant Infobionic, Inc.

K-Number K230265

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QRG 2023-10-06

ScanNav Anatomy Peripheral Nerve Block

Applicant Intelligent Ultrasound Limited

K-Number K232787

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PIF 2023-10-06

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection

Applicant Xeridiem Medical Devices, A Spectrum Plastics Group Company

K-Number K232046

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FAJ 2023-10-06

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

Applicant Medimaging Integrated Solution, Inc (Miis)

K-Number K223926

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LNH 2023-10-06

Swoop® Portable MR Imaging System®

Applicant Hyperfine, Inc.

K-Number K232760

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GEI 2023-10-06

Cautery Protective Actuation System (CPAS)

Applicant Safer Surgeries Medical Devices, LLC

K-Number K232407

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QGM 2023-10-06

Edison System

Applicant HistoSonics, Inc.

K-Number DEN220087

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HTN 2023-10-06

Arthrex FiberTape and TigerTape Cerclage Sutures

Applicant Arthrex, Inc.

K-Number K232755

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