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

QEW 2024-05-29

SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02)

Applicant Devoro Medical, Inc.

K-Number K241207

View Details →

NEY 2024-05-29

Temperature Sensor Probe (ABL-18TP20)

Applicant Varian Medical Systems, Inc.

K-Number K240784

View Details →

GEX 2024-05-29

InnoVoyce VYLO

Applicant Innovoyce

K-Number K240159

View Details →

QNQ 2024-05-29

PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

Applicant Poonglim Pharmatech, Inc.

K-Number K241190

View Details →

PHX 2024-05-29

AltiVate Reverse® Glenoid

Applicant Encore Medical L.P.

K-Number K233481

View Details →

NHA 2024-05-29

EK Digital Abutments

Applicant Hiossen, Inc.

K-Number K233389

View Details →

BTY 2024-05-28

SpiroSphere, SpiroSphereECG, CardioSphere

Applicant Eresearchtechnology GmbH

K-Number K223629

View Details →

MRN 2024-05-28

EVOLVE Nitric Oxide Delivery System

Applicant Malinckrodt Manufacturing, LLC

K-Number K240410

View Details →

DQA 2024-05-28

ANNE Limb

Applicant Sibel Health, Inc.

K-Number K240305

View Details →

GEX 2024-05-28

Regenalase Laser System

Applicant Ipg Medical

K-Number K233344

View Details →

LZA 2024-05-28

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

Applicant Xingyu Medical Tech Co., Ltd.

K-Number K240629

View Details →

KIF 2024-05-28

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

Applicant Enpuno Biotechnology Co., Ltd.

K-Number K240304

View Details →

Page 532 of 2685

↑