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

MUD 2023-05-26

Cerebral Adaptive Index (CAI) Algorithm

Applicant Edwards Lifesciences, LLC

K-Number K223651

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KGO 2023-05-26

Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs

Applicant Ansell Healthcare Products, LLC

K-Number K213289

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MAX 2023-05-26

Kodiak Lumbar Spacer System

Applicant Met One Technologies, LLC

K-Number K230851

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PNZ 2023-05-26

VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System

Applicant Fiagon GmbH

K-Number K230065

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KRH 2023-05-26

WellsForm Tricuspid Annuloplasty Band (WF)

Applicant Genesee Biomedical, Inc.

K-Number K230679

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FGE 2023-05-26

Niti-S Biliary Speed D Stent

Applicant Taewoong Medical Co., Ltd.

K-Number K223626

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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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