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

LIT 2023-05-26

Finesse™ Injectable PTA Balloon Dilatation Catheter

Applicant Summa Therapeutics, LLC

K-Number K230263

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OLO 2023-05-26

CD Horizon™ Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K231184

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NKB 2023-05-26

Dark Star Deformity Pedicle Screw System

Applicant Republic Spine, LLC

K-Number K223096

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LLZ 2023-05-26

Pre-Sure

Applicant Lazarus 3D

K-Number K230044

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KCT 2023-05-26

Sweden & Martina Surgical Trays

Applicant Sweden & Martina S.P.A.

K-Number K222640

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FLL 2023-05-25

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

Applicant Circa Scientific, Inc.

K-Number K222311

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JEH 2023-05-25

Model 9160 VitaloQUB

Applicant Vitalograph Ireland, Ltd.

K-Number K223818

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PBX 2023-05-25

ThermoTK

Applicant Zimmer Medizinsysteme GmbH

K-Number K213256

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EIH 2023-05-25

Soreal Press, Soreal CAD

Applicant Shenzhen Up3D Technology Co., Ltd.

K-Number K230259

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QBS 2023-05-25

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

Applicant Ge Medical Systems, LLC

K-Number K223491

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FMI 2023-05-25

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle

Applicant Nipro Medical Corporation

K-Number K222852

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NHA 2023-05-25

Dentis s-Clean SQ-SL Narrow Implant System

Applicant Dentis Co., Ltd.

K-Number K230246

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