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

OVD 2023-06-16

NuVasive Modulus ALIF System

Applicant Nu Vasive, Incorporated

K-Number K230894

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MMK 2023-06-16

Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421

Applicant Ningbo Maxcon Medical Technology Co., Ltd.

K-Number K222906

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KOC 2023-06-16

Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

Applicant NIKKISO CO., LTD.

K-Number K230514

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HQD 2023-06-16

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens

Applicant Acculens, Inc.

K-Number K230910

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JAK 2023-06-16

SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash

Applicant Siemens Medical Solutions USA, Inc.

K-Number K230421

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FYA 2023-06-16

Surgical Gown

Applicant Hubei Woozon Healthcare Co., Ltd.

K-Number K222999

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FGD 2023-06-16

NAJA Gastrointestinal Catheter

Applicant Chess Medical, Inc.

K-Number K223890

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OZR 2023-06-16

The iNAP One Sleep Therapy System

Applicant Somnics, Inc.

K-Number K220907

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KNW 2023-06-16

OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver

Applicant Laurane Medical Sas

K-Number K230015

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MAX 2023-06-16

Solar Lumbar Interbody Fusion System

Applicant Degen Medical

K-Number K231199

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BTT 2023-06-16

F&P 950 Respiratory Humidifier

Applicant Fisher & Paykel Healthcare

K-Number K220703

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FPA 2023-06-16

Volumat Polyethylene I.V. Administration Set

Applicant Fresenius Kabi

K-Number K221121

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