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

MQC 2024-01-18

LuxCreo Dental Night Guard Resin

Applicant LuxCreo, Inc.

K-Number K230592

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HWC 2024-01-18

TDM Screw System

Applicant Tdm Co., Ltd.

K-Number K231860

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EOQ 2024-01-18

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

Applicant Pentax of America, Inc.

K-Number K232860

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MAX 2024-01-18

Curiteva Porous PEEK Lumbar Interbody Fusion System

Applicant Curiteva, Inc.

K-Number K233744

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GEX 2024-01-18

FlashHeal 2 (FlashHeal 2.0)

Applicant Inwound Aps

K-Number K233077

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GCJ 2024-01-18

Arthrex Synergy Vision Endoscopic Imaging System

Applicant Arthrex, Inc.

K-Number K233451

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QIH 2024-01-18

NemoScan

Applicant Software Nemotec S.L.

K-Number K232698

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JWH 2024-01-18

AMF TT Cones

Applicant Lima Corporate S.P.A.

K-Number K234011

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HRS 2024-01-18

Medline UNITE Ancillary Foot Recon Plating System

Applicant Medline Industires, LP

K-Number K234031

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FTL 2024-01-18

Progrip™ Self-Gripping Polypropylene Mesh

Applicant Sofradim Production

K-Number K232373

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PIO 2024-01-18

ENFit Adaptor

Applicant Jiangsu Caina Medical Co.,Ltd

K-Number K233190

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PEK 2024-01-18

Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3

Applicant Spinal Simplicity, LLC

K-Number K234051

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