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

QDS 2024-11-06

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

Applicant Biofire Diagnostics, LLC (Biomerieux)

K-Number K243222

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GCJ 2024-11-06

MultiCut Solo

Applicant Asclepion Laser Technologies GmbH

K-Number K240831

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OHT 2024-11-06

Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K242039

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MBH 2024-11-06

Agility Symmetric™ Total Knee System

Applicant Medisurge, LLC

K-Number K242412

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MQV 2024-11-06

Citrepore™

Applicant Acuitive Technologies, Inc.

K-Number K240450

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DZE 2024-11-06

Accelx Implant System

Applicant Biotech Dental, LLC

K-Number K242261

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PCC 2024-11-06

ELEXIR 2.0 (ALLIVE3)

Applicant Nu Eyne Co., Ltd.

K-Number K242719

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GEH 2024-11-06

Compound W Skin Tag Remover

Applicant Medtech Products, Inc.

K-Number K242803

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DQX 2024-11-06

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

Applicant ABBOTT MEDICAL

K-Number K240997

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NHA 2024-11-05

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K242340

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NUH 2024-11-05

Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K-Number K242332

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MEB 2024-11-05

InfuLife

Applicant First Medical Source, LLC

K-Number K240624

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