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

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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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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GEX 2024-05-20

Diode Laser Hair Removal System (SH-VD910)

Applicant Beijing Sea Heart International Science and Technologyco.Ltd

K-Number K240520

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EIH 2024-05-20

Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)

Applicant Hunan Ceramaster Material Technology Co., Ltd.

K-Number K240772

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DZE 2024-05-20

Dentis s-Clean SQ-SL Fixture

Applicant Dentis Co., Ltd.

K-Number K240511

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LLZ 2024-05-20

MIM - Centiloid Scaling

Applicant Mim Software, Inc.

K-Number K233620

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NKB 2024-05-20

Vector™ Pedicle Screw System

Applicant Innovasis, Inc.

K-Number K241276

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