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

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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JCX 2023-11-03

Easycess Aspiration Pump

Applicant Guangzhou Easycess Medical Co.,Ltd

K-Number K233428

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IPF 2023-11-03

Combo Electrotherapy Device

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K-Number K231440

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LZA 2023-11-03

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Better Care Plastic Technology Co., Ltd.

K-Number K232266

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JWH 2023-11-03

TRAX® CR Total Knee System

Applicant Amplitude

K-Number K230078

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