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

GEI 2025-06-03

gi2000 Electrosurgical Generator

Applicant Cintron Medical Corporation

K-Number K250657

View Details →

FTM 2025-06-03

Endoform Reconstructive Template - PLGA

Applicant Aroa Biosurgery , Ltd.

K-Number K250598

View Details →

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

View Details →

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

View Details →

HIH 2025-06-03

RZ Resectoscope System

Applicant Rz Medizintechnik GmbH

K-Number K243382

View Details →

OUR 2025-06-03

Patriot SI Implant System

Applicant Spinal Simplicity, LLC

K-Number K250001

View Details →

DQY 2025-06-02

GORE® Tri-Lobe Balloon Catheter

Applicant W. L. Gore & Associates, Inc.

K-Number K250410

View Details →

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

View Details →

MAX 2025-06-02

Tera Lumbar Interbody Fusion System (Various PNs)

Applicant Acuity Surgical Devices, LLC

K-Number K251335

View Details →

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

View Details →

JPA 2025-06-02

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

Applicant Sysmex America, Inc.

K-Number K250965

View Details →

PDU 2025-05-31

LimFlow ARC

Applicant LimFlow, Inc.

K-Number K251376

View Details →

Page 329 of 2728

↑