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

OWN 2023-11-06

KARL STORZ ICG Imaging System

Applicant Karl Storz SE & CO. KG

K-Number K232857

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OUY 2023-11-06

Aptima Trichomonas vaginalis Assay

Applicant Hologic, Inc.

K-Number K231316

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QDQ 2023-11-06

Lunit INSIGHT DBT

Applicant Lunit, Inc.

K-Number K231470

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NZE 2023-11-03

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System

Applicant Zoll Circulation, Inc.

K-Number K231182

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NUH 2023-11-03

ManaFlexx 2 (model: MF002-RX, MF002-OTC)

Applicant Manamed, Inc.

K-Number K231569

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HGX 2023-11-03

Evenflo Premium Double Electric Breast Pump (Model 4018)

Applicant Evenflo Feeding, Inc.

K-Number K230481

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QJI 2023-11-03

Control-IQ Technology

Applicant Tandem Diabetes Care, Inc.

K-Number K232382

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IYE 2023-11-03

Halcyon, Ethos Radiotherapy System

Applicant Varian Medical Systems, Inc.

K-Number K232113

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FPA 2023-11-03

ProSeal™ Closed System Administration Set

Applicant Epic Medical Pte. , Ltd.

K-Number K230343

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QIH 2023-11-03

aprevo® Digital Segmentation

Applicant Carlsmed, Inc.

K-Number K231955

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HWC 2023-11-03

APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension

Applicant Medartis AG

K-Number K232251

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QFG 2023-11-03

t:slim X2 Insulin Pump with Interoperable Technology

Applicant Tandem Diabetes Care, Inc.

K-Number K232380

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