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

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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MBI 2024-01-17

Footprint Mini PK, 3.5mm Suture Anchor

Applicant Smith & Nephew

K-Number K233730

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LDJ 2024-01-17

Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50

Applicant Co-Innovation Biotech Co., Ltd.

K-Number K232732

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KNW 2024-01-17

M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle

Applicant Canyon Medical, Inc.

K-Number K233031

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