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

QVJ 2023-03-02

Plasma Pen (Plasma MD); Plasma Pen (Plasma +)

Applicant Plasma Concepts

K-Number K223440

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QBS 2023-03-02

BoneView

Applicant Gleamer

K-Number K222176

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FMK 2023-03-02

Tenderfoot

Applicant Accriva Diagnostics, Inc.

K-Number K223352

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DQY 2023-03-02

6F Wallaby Long Sheath

Applicant Wallaby Medical, Inc.

K-Number K222603

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QLG 2023-03-01

Bigfoot Unity® Diabetes Management System

Applicant Bigfoot Biomedical, Inc.

K-Number K222280

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PGY 2023-03-01

32HQ713D

Applicant Lg Electronics.Inc

K-Number K223423

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DYB 2023-03-01

Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)

Applicant ABBOTT MEDICAL

K-Number K230283

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PBX 2023-03-01

RSHOCK

Applicant Swims America Corp

K-Number K220014

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DQX 2023-03-01

ProTrack Pigtail Wire

Applicant Baylis Medical Company, Inc.

K-Number K213898

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LLZ 2023-03-01

Xeleris V Processing and Review System

Applicant GE Healthcare

K-Number K221680

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LLZ 2023-03-01

Advantis Platform

Applicant Advantis Medical Imaging Single Member P.C.

K-Number K222975

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KTI 2023-03-01

Multistage Balloon Dilatation Catheter

Applicant Dongguan TT Medical, Inc.

K-Number K222187

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