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

EBF 2024-10-01

Crown HT

Applicant Sprintray, Inc.

K-Number K242277

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NRY 2024-10-01

Esperance 3+ Aspiration Catheter System

Applicant Wallaby Medical

K-Number K240917

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ODC 2024-10-01

Disposable Endoscope Valves Set (AF series)

Applicant Alton (Shanghai) Medical Instruments Co., Ltd.

K-Number K241285

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QIH 2024-10-01

LungVision

Applicant Bodyvision Medical , Ltd.

K-Number K240943

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IZL 2024-10-01

GM85

Applicant Samsung Electronics Co., Ltd.

K-Number K242651

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NFT 2024-10-01

Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC

Applicant Aicheck Biotech, Inc.

K-Number K242498

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JWY 2024-10-01

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.

Applicant Thermo Fisher Scientific

K-Number K241967

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CGA 2024-09-30

YSI 2900C Biochemistry Analyzer

Applicant Ysi, Inc.

K-Number K210933

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QZQ 2024-09-30

OcuCool

Applicant Recensmedical, Inc.

K-Number DEN230011

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DQY 2024-09-30

CrossFAST Integrated Microcatheter Guide Extension System (CFM55)

Applicant Vantis Vascular, Inc.

K-Number K242276

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JOJ 2024-09-30

Kem Medical Lead-free Chemical Indicators for Steam Sterilization

Applicant Kem Medical Products Corporation

K-Number K241836

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EIH 2024-09-30

LUXEN 5G

Applicant Dentalmax Co., Ltd.

K-Number K241151

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