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

FMI 2021-06-23

NovoFine

Applicant Novo Nordisk, Inc.

K-Number K210258

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OLO 2021-06-23

CD Horizon Spinal System

Applicant Medtronic

K-Number K211596

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MTD 2021-06-23

Reprocessed PentaRay Nav eco High-Density Mapping Catheter

Applicant Sterilmed Inc. (Johnson and Johnson)

K-Number K201806

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LYZ 2021-06-23

Synthetic Vinyl Examination Gloves

Applicant Jiangsu Huayuan Medical Technology Co., Ltd.

K-Number K211045

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KWQ 2021-06-23

CervAlign® Anterior Cervical Plate System

Applicant Pioneer Surgical Technology, Inc.

K-Number K211408

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NAY 2021-06-23

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K211595

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NHA 2021-06-23

Straumann CARES M-Series CAD/CAM System

Applicant Institut Straumann AG

K-Number K203456

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DZE 2021-06-23

S.I.N. Dental Implant System

Applicant S.I.N. - Sistema DE Implante Nacional S.A.

K-Number K203725

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DZE 2021-06-22

AnyOne Onestage Implant System

Applicant Megagen Implant Co., Ltd.

K-Number K210161

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IRP 2021-06-22

LF900

Applicant Daesung Maref Co., Ltd.

K-Number K203019

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FTC 2021-06-22

M Series Phototherapy Equipment

Applicant Daavlin Distributing Co.

K-Number K210881

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MUE 2021-06-22

SenoBright HD

Applicant GE Healthcare

K-Number K211215

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