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

IMI 2023-10-24

Sonopuls 190

Applicant Enraf-Nonius, B.V.

K-Number K230472

View Details →

OWQ 2023-10-24

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter

Applicant Vein 360, LLC

K-Number K232584

View Details →

IYN 2023-10-24

Aco Apache Ultrasound System

Applicant Aco Healthcare Co., Ltd.

K-Number K231509

View Details →

DXN 2023-10-24

Acumen IQ finger cuff

Applicant Edwards Lifesciences, LLC

K-Number K230919

View Details →

MOS 2023-10-24

16 Breast Coil

Applicant Philips Medical System Nederlands B.V.

K-Number K233348

View Details →

DQX 2023-10-24

Steerant™ Super Stiff Guidewire

Applicant Medtronic Vascular

K-Number K232570

View Details →

OUR 2023-10-24

REUNION Sacroiliac Joint Fusion System

Applicant Astura Medical

K-Number K232211

View Details →

LLZ 2023-10-24

spineEOS

Applicant Eos Imaging

K-Number K232086

View Details →

DWJ 2023-10-24

FilteredFlo Warming Blankets

Applicant Iob Medical, Inc.

K-Number K232638

View Details →

FEO 2023-10-23

Swiss LthoClast Trilogy

Applicant E.M.S Electro Medical Systems S.A

K-Number K230893

View Details →

HKY 2023-10-23

Applanation Tonometer HT-5000

Applicant Huvitz Co., Ltd.

K-Number K232143

View Details →

MBI 2023-10-23

Shadow Knotless All-Suture Anchors

Applicant Responsive Arthroscopy, LLC

K-Number K233258

View Details →

Page 761 of 2738

↑