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

ELC 2024-03-11

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG

Applicant Satelec - Acteon Group

K-Number K233922

View Details →

LFD 2024-03-11

Caphosol® Artifical Saliva (32 doses sachet box)

Applicant Eusa Pharma (Uk) Limited

K-Number K234015

View Details →

NHA 2024-03-09

Osteon Precision Milled Suprastructure

Applicant Implant Solutions Pty Ltd (Aka Osteon Medical)

K-Number K233083

View Details →

MQR 2024-03-08

WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System

Applicant Boston Scientific Corporation

K-Number K234046

View Details →

GWJ 2024-03-08

ALGO Pro Newborn Hearing Screener (ALGO Pro)

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K233649

View Details →

HJO 2024-03-08

HP-OCT (HP-OCT)

Applicant Cylite Pty. , Ltd.

K-Number K231760

View Details →

FBK 2024-03-08

Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)

Applicant Steris

K-Number K232826

View Details →

OHT 2024-03-08

Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)

Applicant Shenzhen Mlay Intelligent Technology Co., , Ltd.

K-Number K240264

View Details →

HWC 2024-03-08

OSSIOfiber® Threaded Trimmable Fixation Nails

Applicant OSSIO , Ltd.

K-Number K233198

View Details →

SBF 2024-03-08

Knee+

Applicant Pixee Medical

K-Number K233899

View Details →

MQK 2024-03-08

Nest VT Vitrification Device

Applicant Cook Incorporated

K-Number K233177

View Details →

QJP 2024-03-08

Esperance Distal Access Catheter

Applicant Wallaby Medical

K-Number K231056

View Details →

Page 664 of 2738

↑