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

QIH 2024-04-17

uOmnispace.MR

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K233186

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LPL 2024-04-17

Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens

Applicant Innova Vision, Inc.

K-Number K240519

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PSY 2024-04-16

Sectra Digital Pathology Module (Version 3.3)

Applicant Sectra AB

K-Number K232208

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LHI 2024-04-16

nextaro® v, 20/20

Applicant Sfm Medical Devices GmbH

K-Number K240748

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PKT 2024-04-16

ReBorn (1050nm)

Applicant Lightfective , Ltd.

K-Number K233962

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FDT 2024-04-16

Ambu® aScope Duodeno 2, Ambu® aBox 2

Applicant Ambu A/S

K-Number K233886

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GEX 2024-04-16

Co2 Laser System, Models: PureLase And VanLase

Applicant Cpmt Laser (Canadian Pioneer Medical Technology Corporation)

K-Number K232133

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KWQ 2024-04-16

Alcantara Thoracolumbar Plate System

Applicant Camber Spine Technologies, LLC

K-Number K232256

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PSY 2024-04-16

Aperio GT 450 DX

Applicant Leica Biosystems Imaging, Inc.

K-Number K232202

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NHA 2024-04-15

Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments

Applicant Medentika GmbH

K-Number K223113

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CIN 2024-04-15

Access Ostase

Applicant Beckman Coulter

K-Number K232904

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EZL 2024-04-15

Folysil Silicone Catheter

Applicant Coloplast Corp.

K-Number K233411

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