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

LZA 2024-01-26

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs

Applicant Anhui Intco Medical Products Co., Ltd.

K-Number K233598

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HGX 2024-01-26

Perifit Pump

Applicant X6 Innovations

K-Number K231785

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KNT 2024-01-26

ViSiGi 3D Gastric Sizing Tube

Applicant Boehringer Laboratories

K-Number K234145

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LCX 2024-01-26

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II

Applicant Nantong Egens Biotechnology Co., Ltd.

K-Number K232864

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PKL 2024-01-26

Disposable Hemostatic Clips

Applicant Zhejiang Soudon Medical Technology Co., Ltd.

K-Number K232450

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QNR 2024-01-26

CentriMag™ Acute Circulatory Support System

Applicant ABBOTT MEDICAL

K-Number K234118

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OWB 2024-01-26

Ziehm Solo FD

Applicant Ziehm Imaging GmbH

K-Number K234109

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LSL 2024-01-26

Aptima Neisseria gonorrhoeae Assay

Applicant Hologic, Inc.

K-Number K231329

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DXN 2024-01-26

Arm-type Fully Automatic Digital Blood Pressure Monitor

Applicant Joytech Healthcare Co. , Ltd.

K-Number K231303

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PLF 2024-01-26

Trigon Trigon HA Stand-Alone Wedge Fixation System

Applicant Nvision Biomedical Technologies

K-Number K234116

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IPF 2024-01-26

M-Wave

Applicant Zynex Medical, Inc.

K-Number K233485

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OLO 2024-01-26

ExactechGPS® System

Applicant Blue Ortho

K-Number K233299

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