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

NJM 2022-09-14

LightForce Orthodontic System

Applicant Lightforce Orthodontics

K-Number K222764

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MNR 2022-09-14

WatchPAT300 (WP300)

Applicant Itamar Medical , Ltd.

K-Number K222331

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PKC 2022-09-14

Tornier Perform Humeral System Stemless

Applicant Tornier, Inc.

K-Number K220418

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DXC 2022-09-14

GEM Biover Microvascular Clamps

Applicant Synovis Micro Companies Alliance, Inc.

K-Number K221843

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PKL 2022-09-14

Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip

Applicant Boston Scientific Corporation

K-Number K222503

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MQL 2022-09-14

V-HEPES PLUS

Applicant Vitromed Langenfeld

K-Number K213293

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JBF 2022-09-14

FINDER G6PD

Applicant Baebies, Inc.

K-Number K201049

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EBI 2022-09-14

SprintRay Denture Base

Applicant Sprintray, Inc.

K-Number K220979

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DRC 2022-09-14

SafeSept® Transseptal Guidewire (SS-140)

Applicant Pressure Products Medical Device Manufacturing, LLC

K-Number K221707

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DZE 2022-09-14

TSX Implants

Applicant Biomet 3i, LLC

K-Number K220978

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FOZ 2022-09-13

MagiCath II

Applicant Woo Young Medical Co., Ltd.

K-Number K210929

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NHI 2022-09-13

Primary Relief

Applicant Dyansys, Inc.

K-Number K221425

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