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

QIH 2024-11-05

TeraRecon Cardiac.Chambers.MR (1.0.0)

Applicant Terarecon,Inc.

K-Number K241312

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GWF 2024-11-05

Delphi Stimulator

Applicant Quantalx Neuroscience

K-Number K242345

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FMK 2024-11-05

gentleheel® Adult Incision Device

Applicant Gri-Alleset, Inc.

K-Number K242664

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LLZ 2024-11-04

JLK-PWI

Applicant JLK, Inc.

K-Number K242709

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ORZ 2024-11-04

Tixel i (TXLI0001)

Applicant Novoxel , Ltd.

K-Number K240512

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SDE 2024-11-04

Valeda Light Delivery System

Applicant Lumithera, Inc.

K-Number DEN230083

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FRG 2024-11-04

CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)

Applicant Comercializadora Brever

K-Number K240438

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DYB 2024-11-04

SonoStik Guide Wire Introducer

Applicant Sonostik, LLC

K-Number K243061

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NBW 2024-11-04

RIGHTEST Blood Glucose Monitoring System Max Tel

Applicant Bionime Corporation

K-Number K240637

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NUH 2024-11-04

Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)

Applicant Changsha Anxiang Medical Technology Co., Ltd.

K-Number K242567

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ODP 2024-11-04

Gemini Cervical Fusion Cage System

Applicant ZheJiang Decans Medical Devices Co., Ltd.

K-Number K242195

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EHD 2024-11-01

XERO-alpha

Applicant DRTECH Corporation

K-Number K242591

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