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

GEI 2024-11-26

Cellinew

Applicant VIOL Co., Ltd.

K-Number K240897

View Details →

LNH 2024-11-26

MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)

Applicant Asg Superconductors S.P.A.

K-Number K242258

View Details →

JAQ 2024-11-26

Intraluminal Applicator Set

Applicant Varian Medical Systems

K-Number K242961

View Details →

OWY 2024-11-26

REGENETEN Bioinductive Implant

Applicant Smith & Nephew Inc., Endoscopy Div.

K-Number K242631

View Details →

EBG 2024-11-26

Digital Temp

Applicant Sprintray, Inc.

K-Number K242559

View Details →

MEH 2024-11-25

World Liner

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K243162

View Details →

NGX 2024-11-25

EMS Sculpt Machine

Applicant Shandong Huamei Technology Co., Ltd.

K-Number K232982

View Details →

GXY 2024-11-25

WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)

Applicant Eemagine Medical Imaging Solutions GmbH

K-Number K240575

View Details →

ITI 2024-11-25

Electric Wheelchair (KR8803)

Applicant Zhejiang Kairui Medical Device Co., Ltd.

K-Number K241588

View Details →

PQA 2024-11-25

Aptima BV Assay; Aptima CV/TV Assay

Applicant Hologic, Inc.

K-Number K243345

View Details →

FRC 2024-11-25

3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M

Applicant 3M Company

K-Number K242538

View Details →

QDQ 2024-11-25

Transpara (2.1.0)

Applicant Screenpoint Medical B.V.

K-Number K241831

View Details →

Page 399 of 2685

↑