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

HAW 2021-01-22

ClearPoint Array System

Applicant ClearPoint Neuro, Inc.

K-Number K202575

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OUR 2021-01-22

Advanced Research Medical Trident SI Screw System

Applicant Advanced Research Medical, LLC

K-Number K203373

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FLL 2021-01-22

Non-Contact Forehead Thermometer (UT30H)

Applicant Uni-Trend Technology (China) Co., Ltd.

K-Number K203656

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GEI 2021-01-22

ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length

Applicant Ethicon Endo-Surgery, LLC

K-Number K201066

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NHI 2021-01-22

SPRINT PNS System

Applicant Spr Therapeutics, Inc.

K-Number K202660

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NXC 2021-01-22

BRIUS Clear Aligners

Applicant Brius Technologies, Inc.

K-Number K202792

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LJS 2021-01-22

Piccolo Medical SmartPICC System

Applicant Piccolo Medical, Inc.

K-Number K200037

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FXX 2021-01-22

Surgical Mask

Applicant Jiangsu Medpure Biological Technology Co., Ltd.

K-Number K202640

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DXN 2021-01-22

EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform

Applicant Edwards Lifesciences, LLC

K-Number K203131

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FPA 2021-01-21

Precision Delivery Infusion Set

Applicant Quest Medical, Inc.

K-Number K202672

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NUC 2021-01-21

pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5

Applicant Pjur Group Luxembourg S.A.

K-Number K200731

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JOW 2021-01-21

Overlapped Compression Therapy

Applicant Jkh Health Co., Ltd.

K-Number K202839

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