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

HRS 2021-01-28

Biomet Microfixation RibFix Advantage System

Applicant Biomet Micofixation

K-Number K203474

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FRO 2021-01-28

LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K201016

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NKB 2021-01-28

Vitality® Spinal Fixation System

Applicant Zimmer Biomet Spine, Inc.

K-Number K203507

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KCT 2021-01-28

Standard Sterilizable Tray

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K202524

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OSF 2021-01-28

HipXpert 3D Display and Anchoring Application

Applicant Surgical Planning Associates, Inc.

K-Number K200384

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NZA 2021-01-28

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide

Applicant Steris

K-Number K203223

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EIH 2021-01-28

GenesisZr UHT700 Zirconia

Applicant United Dental Resources Corporation

K-Number K201608

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DXN 2021-01-27

Wrist Electronic Sphygmomanometer

Applicant Shenzhen Changkun Technology Co., Ltd.

K-Number K193386

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DXN 2021-01-27

Arm Electronic Sphygmomanometer

Applicant Shenzhen Changkun Technology Co., Ltd.

K-Number K193387

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NOU 2021-01-27

Vivo 45 LS

Applicant Breas Medical AB

K-Number K193586

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HRS 2021-01-27

EVOS Large Fragment Plating System

Applicant Smith & Nephew, Inc.

K-Number K203405

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NKB 2021-01-26

Altus Spine HA Pedicle Screw System

Applicant Altus Partners, LLC

K-Number K200922

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