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

ODC 2025-03-19

Luer-Split MAJ-2092

Applicant Olympus Medical Systems Corporation

K-Number K241842

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SEW 2025-03-19

CORIS System

Applicant Nanosonics Limited

K-Number DEN240018

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MQB 2025-03-19

EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP

Applicant DRTECH Corporation

K-Number K243443

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HRS 2025-03-19

TriMed Elbow and Forearm System

Applicant TriMed, Inc.

K-Number K243987

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MNR 2025-03-19

AcuPebble Ox (200)

Applicant Acurable Limited

K-Number K243092

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QAI 2025-03-19

1NEED Pro

Applicant Campomats S.R.L.

K-Number K243472

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EOQ 2025-03-19

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

Applicant Scivita Medical Technology Co., Ltd.

K-Number K250210

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HRS 2025-03-19

TriMed Ankle Fixation System

Applicant TriMed, Inc.

K-Number K243999

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NZE 2025-03-18

CarbonCool® System

Applicant Global Healthcare SG Sdn. Bhd

K-Number K240933

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QDQ 2025-03-18

QP-Prostate® CAD

Applicant Quibim S.L.

K-Number K242683

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LZA 2025-03-18

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

Applicant Better Care Plastic Technology Co., Ltd.

K-Number K242533

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LQR 2025-03-18

Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P

Applicant Olympus Medical Systems Corp.

K-Number K243807

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