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

QSY 2024-05-22

Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)

Applicant Ushare Medical, Inc.

K-Number K240097

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DXE 2024-05-22

Fogarty Arterial Embolectomy Catheter with Gate Valve

Applicant Edwards Lifesciences

K-Number K233820

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FMK 2024-05-21

Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K240806

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HHW 2024-05-21

Reia pessary

Applicant Reia, LLC

K-Number K232677

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LLZ 2024-05-21

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

Applicant Brainlab AG

K-Number K232759

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ONB 2024-05-21

ProSeal Injection Site Extended Male Luer Lock (422140)

Applicant Epic Medical Pte. , Ltd.

K-Number K240433

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PGY 2024-05-21

21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01)

Applicant Acula Technology Corp.

K-Number K233336

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JOJ 2024-05-21

3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190

Applicant 3M Company

K-Number DEN230068

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OZE 2024-05-21

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)

Applicant Centers for Disease Control and Prevention

K-Number K241110

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GKZ 2024-05-21

Yumizen H2500

Applicant HORIBA ABX SAS

K-Number K232946

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KPR 2024-05-21

YSIO X.pree

Applicant Siemens Medical Solutions

K-Number K233543

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OCX 2024-05-21

troCarWash System

Applicant Biotex, Inc.

K-Number K233442

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