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

HRX 2021-06-24

SMARTRELEASE Endoscopic Soft Tissue Release System

Applicant Microaire Surgical Instruments

K-Number K211297

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EBF 2021-06-24

Renamel Bulkfill

Applicant Cosmedent, Inc.

K-Number K211259

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PHX 2021-06-24

OVOMotion Reverse Shoulder Arthroplasty System

Applicant Arthrosurface, Inc.

K-Number K203375

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NKB 2021-06-23

Mariner Deformity System

Applicant SeaSpine Orthopedics Corporation

K-Number K211606

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HRS 2021-06-23

Valkyrie Thoracic Fixation System

Applicant Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices

K-Number K211695

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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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