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

PIF 2026-09-10

danumed Extension Set for Gastrostomy Button

Applicant Danumed Medizintechnik GmbH

K-Number K260110

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LZA 2026-09-09

Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)

Applicant Maxter Healthcare, Inc.

K-Number K261793

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MYN 2026-09-09

ChestView US (1.1)

Applicant Gleamer

K-Number K252486

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FGB 2026-09-09

Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K262488

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LZA 2026-09-09

Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim

Applicant Top Glove Sdn. Bhd.

K-Number K262542

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KGN 2026-09-09

ColActive Plus

Applicant Covalon Technologies, Ltd.

K-Number K260652

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PLL 2026-09-09

SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)

Applicant Endoclot Plus Co., Ltd.

K-Number K260997

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NHV 2026-09-09

QF10

Applicant E.A.M Benelux B.V

K-Number K261470

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QIH 2026-09-09

ReVISION 2

Applicant Argus Cognitive, Inc.

K-Number K251417

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KPR 2026-09-08

EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H

Applicant DRTECH Corporation

K-Number K260227

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HIH 2026-09-08

Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)

Applicant Zhejiang Geyi Medical Instrument Co., Ltd.

K-Number K254294

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NAY 2026-09-08

da Vinci Surgical System, Model IS5000

Applicant Intuitive Surgical, Inc.

K-Number K261823

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