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

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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EIA 2024-02-28

Dental unit Model: Mare

Applicant Foshan Safety Medical Equipment Co., Ltd.

K-Number K231845

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QIH 2024-02-28

CT Cardiomegaly

Applicant Innolitics, LLC

K-Number K232613

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GEI 2024-02-28

OsteoCool™ 2.0 RF Ablation System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K233830

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