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

QOF 2024-03-26

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

Applicant Biofire Diagnostics, LLC

K-Number K232954

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NHA 2024-03-25

LW Implant System – Abutment

Applicant Ossvis Co., Ltd.

K-Number K233167

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DZE 2024-03-25

STERI-OSS Implant System

Applicant Zeros Co., Ltd.

K-Number K232268

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FGB 2024-03-25

RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)

Applicant Gyrus Acmi, Inc.

K-Number K233275

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NUH 2024-03-25

Transcutaneous Electrical Nerve Stimulator (9029SCM)

Applicant Hong Kong Etech Groups Limited

K-Number K240292

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GEX 2024-03-25

LUNE™ PureHygiene

Applicant Enamel Pure

K-Number K234085

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GWF 2024-03-25

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

Applicant Soterix Medical, Inc.

K-Number K234080

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HRS 2024-03-25

VariAx 2 Distal Radius System

Applicant Stryker GmbH

K-Number K233919

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IZI 2024-03-25

Modus IR

Applicant Synaptive Medical, Inc.

K-Number K231986

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LLZ 2024-03-25

Cube Navigator

Applicant Medical Templates AG

K-Number K240620

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DYB 2024-03-25

Micropuncture Introducer Sets; Micropuncture Pedal Access Sets

Applicant Cook Medical

K-Number K240589

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ITI 2024-03-25

Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)

Applicant Yongkang Youha Electric Appliance Co., Ltd.

K-Number K240329

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