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

KPS 2021-03-03

Biograph Vision Quadra PET/CT System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K210262

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PZX 2021-03-03

AtriClip LAA Exclusion System

Applicant AtriCure, Inc.

K-Number K210293

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FXX 2021-03-03

Medical mask (Model: KKF-1A)

Applicant Han Zhaoqing Sporting Goods Company Limited

K-Number K202316

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FRC 2021-03-03

3M Attest Rapid Readout Biological Indicator, 1295

Applicant 3M Company

K-Number K210277

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MAH 2021-03-03

Ponto Bone Anchored Hearing System, MONO Surgery Kit

Applicant Oticon Medical AB

K-Number K203807

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DQY 2021-03-03

FineCross M3

Applicant Ashitaka Factory of Terumo Corporation

K-Number K203521

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LNH 2021-03-03

Promaxo MRI System

Applicant Promaxo, Inc.

K-Number K202518

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HRS 2021-03-03

LOQTEQ Distal Lateral Femur Plate 4.5 System

Applicant Aap Implantate AG

K-Number K210043

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OCW 2021-03-02

OverStitch Sx Endoscopic Suturing System

Applicant Apollo Endosurgery, Inc.

K-Number K210266

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JFB 2021-03-02

Ceragem Automatic Thermal Massager, Model CGM-MB-1901

Applicant Ceragem Co., Ltd.

K-Number K202113

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LNH 2021-03-02

MRI PPG Patient Cable

Applicant Ivy Biomedical Systems, Inc.

K-Number K203653

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PHX 2021-03-02

Shoulder System - TiNbN Coating

Applicant Medacta International S.A.

K-Number K203755

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