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

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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QQV 2023-03-20

Colibrí

Applicant Copan Wasp Srl

K-Number K223245

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NUH 2023-03-20

TENS and EMS Stimulation (OTC)

Applicant Changsha Yuwen Medical Equipment Co., Ltd.

K-Number K230174

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FMI 2023-03-20

Shina Safety Needle

Applicant Shina Corporation

K-Number K222417

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CIG 2023-03-20

Atellica® CH Diazo Total Bilirubin (D_TBil)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K222104

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NUH 2023-03-20

TENS and EMS Stimulation (OTC)

Applicant Changsha Yuwen Medical Equipment Co., Ltd.

K-Number K230163

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LNH 2023-03-20

MOBINEURO Alita Intraoperative MRI System

Applicant Sino Canada Health Engineering Research Institute (Hefei)

K-Number K223875

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GEI 2023-03-20

HPR45i

Applicant F Care Systems USA, LLC

K-Number K220725

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