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

QAU 2022-09-16

Nexpowder

Applicant Nextbiomedical Co., Ltd.

K-Number K202929

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BTA 2022-09-16

Exsalta

Applicant Drw Medical

K-Number K221676

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OTN 2022-09-15

ArcTO Transobturator Sling System

Applicant Urocure, LLC

K-Number K222468

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MBF 2022-09-15

Identity Shoulder System

Applicant Zimmer, Inc.

K-Number K213856

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IYN 2022-09-15

P12 Elite Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K221089

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JTN 2022-09-15

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K-Number K203336

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ONN 2022-09-15

TrueBalance Surgical System

Applicant These Three Medical, LLC

K-Number K220830

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OHT 2022-09-15

Diamond Air+ (UI04A, UI04B, UI04C)

Applicant Ulike Co., Ltd.

K-Number K221553

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GEX 2022-09-15

CO2 Laser System

Applicant Smedtrum Medical Technology Co., Ltd.

K-Number K221597

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FMG 2022-09-15

SafePort(TM) Manifold (or Stopcock)

Applicant Elcam Medical Acal

K-Number K211204

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MAX 2022-09-15

MONDRIAN ALIF Cage with Supplementary Fixation Plate

Applicant Ctl Medical Corporation

K-Number K213641

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LPL 2022-09-15

AIR OPTIX COLORS

Applicant Alcon Laboratories, Inc.

K-Number K222500

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