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

PKL 2026-09-14

colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)

Applicant Ovesco Endoscopy AG

K-Number K253481

View Details →

FMK 2026-09-13

Safety lancet (XL)

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K262526

View Details →

MSX 2026-09-12

Digistat Care

Applicant Ascom Ums Srl Unipersonale

K-Number K261287

View Details →

QNP 2026-09-12

CADDIE

Applicant Odin Medical Limited

K-Number K260133

View Details →

GEI 2026-09-11

Potenza Prime

Applicant Jeisys Medical Incorporated

K-Number K254185

View Details →

GWO 2026-09-11

CraniUS Plate

Applicant CraniUS, LLC

K-Number K262874

View Details →

FED 2026-09-11

Single Use Ureteral Access Sheath

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K260410

View Details →

JWH 2026-09-11

GSPE Spacer

Applicant The General Hospital Corporation, d/b/a Massachusetts

K-Number K260063

View Details →

OVD 2026-09-11

Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System

Applicant INNO Holdings Inc. DBA Innovasis

K-Number K262025

View Details →

GCJ 2026-09-11

CuratOR EX2742

Applicant Eizo Corporation

K-Number K262397

View Details →

OVB 2026-09-11

SpaceOAR Flex™ System

Applicant Boston Scientific Corporation

K-Number K262151

View Details →

QJI 2026-09-11

iLet Dosing Decision Software

Applicant Beta Bionics, Inc.

K-Number K262763

View Details →

Page 28 of 14150

↑