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

FTM 2025-06-03

Endoform Reconstructive Template - PLGA

Applicant Aroa Biosurgery , Ltd.

K-Number K250598

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FOZ 2025-06-03

BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K250682

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LZA 2025-06-03

GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

Applicant Glove One, LLC

K-Number K243796

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HIH 2025-06-03

RZ Resectoscope System

Applicant Rz Medizintechnik GmbH

K-Number K243382

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OUR 2025-06-03

Patriot SI Implant System

Applicant Spinal Simplicity, LLC

K-Number K250001

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DQY 2025-06-02

GORE® Tri-Lobe Balloon Catheter

Applicant W. L. Gore & Associates, Inc.

K-Number K250410

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MBI 2025-06-02

PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop

Applicant Science & Bio Materials (S.B.M.) Sas

K-Number K250844

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MAX 2025-06-02

Tera Lumbar Interbody Fusion System (Various PNs)

Applicant Acuity Surgical Devices, LLC

K-Number K251335

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FED 2025-06-02

CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)

Applicant MacroLux Medical Technology Co., Ltd.

K-Number K250452

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JPA 2025-06-02

Automated Blood Coagulation Analyzer CN-Series (CN-6000)

Applicant Sysmex America, Inc.

K-Number K250965

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PDU 2025-05-31

LimFlow ARC

Applicant LimFlow, Inc.

K-Number K251376

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QAS 2025-05-30

BriefCase-Triage

Applicant Aidoc Medical , Ltd.

K-Number K251406

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