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

EOB 2023-07-28

PatCom Distal Chip Endoscope

Applicant H&A Mui Enterprises, Inc.

K-Number K222587

View Details →

BZD 2023-07-28

Therapy Mask 3100 NC/SP

Applicant Respironics, Inc.

K-Number K231313

View Details →

FMI 2023-07-27

Altaviz Needle Kit II

Applicant Altaviz, LLC

K-Number K231261

View Details →

FYA 2023-07-27

Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets

Applicant Cardinal Health200, LLC

K-Number K230838

View Details →

EZL 2023-07-27

Teleflex Rusch SoftSimplastic Foley Catheters

Applicant Teleflexmedical, Inc.

K-Number K212077

View Details →

HWC 2023-07-27

IBS-B MIS Beveled Screw System

Applicant In2bones USA, LLC

K-Number K231236

View Details →

OHS 2023-07-27

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))

Applicant iSMART Developments, Ltd.

K-Number K231555

View Details →

OLO 2023-07-27

SURGIVISIO Device

Applicant Ecential Robotics

K-Number K231886

View Details →

QFM 2023-07-27

Rapid Aneurysm Triage and Notification

Applicant Ischemaview, Inc.

K-Number K230074

View Details →

QOF 2023-07-27

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System

Applicant Roche Molecular Systems, Inc.

K-Number K223591

View Details →

DQY 2023-07-27

R2P Navicross

Applicant Terumo Medical Corporation

K-Number K231044

View Details →

PMN 2023-07-27

MDx-Chex for BC-GN

Applicant Streck

K-Number K231223

View Details →

Page 760 of 2685

↑