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

NDN 2024-02-29

Balloon Inflation System

Applicant Ningbo Hicren Biotechnology Co., Ltd.

K-Number K232842

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KWQ 2024-02-29

Curiteva Thoracolumbar Plate System

Applicant Curiteva, Inc.

K-Number K233360

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DTK 2024-02-29

Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit

Applicant Bd

K-Number K240257

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LNH 2024-02-29

MAGNETOM Cima.X Fit

Applicant Siemens Medical Solutions USA, Inc.

K-Number K232765

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OKO 2024-02-29

NPseal (Small, Medium, Large)

Applicant Guard Medical, Inc.

K-Number K240244

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LZA 2024-02-29

Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs

Applicant Lingshi Hongruida Health Protection Technology Co., Ltd.

K-Number K240051

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KWD 2024-02-29

Accu-Joint Hemi Implant

Applicant Accufix Surgical, Inc.

K-Number K240268

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NRY 2024-02-29

APRO 55 Catheter and Alembic Aspiration Tubing

Applicant Alembic, LLC

K-Number K232971

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GEI 2024-02-29

PlazMagik

Applicant Agnes Medical Co., Ltd.

K-Number K230837

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NVK 2024-02-28

Dawn Diode Laser System

Applicant Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

K-Number K232885

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MUD 2024-02-28

Intra.Ox 2.0 Handheld Tissue Oximeter

Applicant Vioptix, Inc.

K-Number K233488

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PDU 2024-02-28

PowerWire Radiofrequency Guidewire Kit

Applicant Baylis Medical Technologies, Inc.

K-Number K232562

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