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

DXN 2024-04-29

Blood Pressure Monitor (TMB-2287-B)

Applicant Guangdong Transtek Medical Electronics Co., Ltd.

K-Number K240102

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HSN 2024-04-29

restor3d Kinos Axiom Total Ankle System

Applicant Restor3D, Inc.

K-Number K240591

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ESW 2024-04-29

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System

Applicant Boston Scientific

K-Number K233939

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OLO 2024-04-29

ARVIS® Shoulder

Applicant Insight Medical Systems, Inc.

K-Number K240062

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CAC 2024-04-29

XTRA Autotransfusion System (with XTRA Bowl sets)

Applicant Sorin Group Italia S.R.L.

K-Number K240584

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NUJ 2024-04-29

Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K232511

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GEI 2024-04-29

Volnewmer™

Applicant Classys, Inc.

K-Number K240248

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JWH 2024-04-26

EMPOWR Revision Symmetric Knee Cones

Applicant Encore Medical, L.P. (Dba Enovis)

K-Number K240324

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JAK 2024-04-26

FCT iSTREAM Phase 1

Applicant FUJIFILM Healthcare Americas Corporation

K-Number K233583

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LNH 2024-04-26

uMR Jupiter

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K233673

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SAN 2024-04-26

ASTar BC G- Kit and ASTar Instrument

Applicant Q-Linea AB

K-Number K221688

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ODE 2024-04-26

EsophyX Z+ Device with SerosaFuse Fasteners and Accessories

Applicant Endogastric Solutions, Inc.

K-Number K240879

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