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

KNS 2023-11-07

Disposable Sphincterotome

Applicant Zhejiang Soudon Medical Technology Co., Ltd.

K-Number K232476

View Details →

HCG 2023-11-07

Axium Detachable Coil; Axium Prime Detachable Coil

Applicant Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

K-Number K233420

View Details →

MAX 2023-11-07

Peridot-EX Expandable Intervertebral Body Fusion System

Applicant Gbs Commonwealth Co., Ltd.

K-Number K232292

View Details →

IYN 2023-11-07

LOGIQ E10s, LOGIQ Fortis

Applicant Ge Medical Systems Ultrasound and Primary Care Diagnostic,

K-Number K231989

View Details →

GCJ 2023-11-07

Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)

Applicant Jiangsu Channel Medical Device Co., Ltd.

K-Number K232866

View Details →

QYO 2023-11-06

EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)

Applicant Stemcell Technologies Canada, Inc.

K-Number DEN220090

View Details →

FMF 2023-11-06

Revital Cady

Applicant Revital Healthcare (Epz) Limited

K-Number K231519

View Details →

OBR 2023-11-06

Mouth Guard (ATG0603R)

Applicant Reazeal Corp

K-Number K231865

View Details →

OWN 2023-11-06

KARL STORZ ICG Imaging System

Applicant Karl Storz SE & CO. KG

K-Number K232857

View Details →

OUY 2023-11-06

Aptima Trichomonas vaginalis Assay

Applicant Hologic, Inc.

K-Number K231316

View Details →

QDQ 2023-11-06

Lunit INSIGHT DBT

Applicant Lunit, Inc.

K-Number K231470

View Details →

NZE 2023-11-03

Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System

Applicant Zoll Circulation, Inc.

K-Number K231182

View Details →

Page 675 of 2685

↑