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

OBP 2023-04-04

NeuroStar Advanced Therapy System (Version 3.7)

Applicant Neuronetics

K-Number K230029

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QLZ 2023-04-04

Reprocessed NRG Transseptal Needle

Applicant Innovative Health, LLC

K-Number K213584

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KYJ 2023-04-04

BRM Digitalis Spacer

Applicant Brm Extremities Srl

K-Number K220142

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QBD 2023-04-03

iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)

Applicant Mawi Dna Technologies

K-Number K221802

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KNW 2023-04-03

M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle

Applicant Canyon Medical, Inc.

K-Number K222865

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NAM 2023-04-03

Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application

Applicant Avation Medical, Inc.

K-Number K220454

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EIA 2023-04-03

G7, Dental Operative Unit and Accessories

Applicant Shinhung Company, Ltd.

K-Number K213749

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JOW 2023-04-03

Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly

Applicant Cardinal Health200, LLC

K-Number K230028

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FBK 2023-04-03

Sclerotherapy & Endoscopic Needles

Applicant G-Flex Europe Sprl

K-Number K222006

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QAS 2023-04-03

Annalise Enterprise CTB Triage Trauma

Applicant Annalise-Ai Pty , Ltd.

K-Number K223240

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DSA 2023-04-02

SpO2 Extension Cable

Applicant Beijing Rongrui-Century Science & Technology Co., Ltd.

K-Number K222370

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MBI 2023-04-01

FiberTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K230568

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