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

PGY 2023-03-21

Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)

Applicant Barco N.V.

K-Number K230520

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JWH 2023-03-21

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

Applicant Waldemar Link GmbH & Co. KG

K-Number K230471

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GEI 2023-03-21

Retraction, CWM-910T, APOLEX Tite

Applicant Chungwoo Co., Ltd.

K-Number K222709

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LLZ 2023-03-21

FlightPlan for Embolization

Applicant GE Medical Systems SCS

K-Number K223490

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MQV 2023-03-21

DSM Biomedical Calcium Phosphate Cement

Applicant Dsm Biomedical

K-Number K230054

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LLZ 2023-03-21

Syngo Carbon Space VA30A

Applicant Siemens Healthcare GmbH

K-Number K230561

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KCT 2023-03-21

Instrument Case P1340904

Applicant Cochlear

K-Number K223672

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OUR 2023-03-21

Entasis 3D Dual-Lead Sacroiliac Implant System

Applicant Corelink, LLC

K-Number K223708

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JWY 2023-03-21

Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)

Applicant Thermo Fisher Scientific

K-Number K223844

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QRK 2023-03-21

EasyTouch Lancing Device

Applicant Stat Medical Devices

K-Number K222617

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FTM 2023-03-21

OviTex PRS (Long Term Resorbable)

Applicant Tela Bio

K-Number K214070

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NTI 2023-03-21

Genomadix Cube CYP2C19 System

Applicant Genomadix, Inc.

K-Number K220026

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