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

PZX 2022-10-28

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

Applicant Syntheon

K-Number K220305

View Details →

GXN 2022-10-28

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Applicant Kontour(XiAn) Medical Technology Co., Ltd.

K-Number K214109

View Details →

FYA 2022-10-28

Disposable Surgical Gown Rk-3011C

Applicant Xiantao Rhycom Non-Woven Products Co., Ltd.

K-Number K211060

View Details →

FMK 2022-10-28

Disposable Safety Lancet

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K221521

View Details →

IOR 2022-10-28

SUPERTILT PLUS (STP)

Applicant Power Plus Mobility

K-Number K221435

View Details →

OQY 2022-10-28

Bakri Essential Postpartum Balloon

Applicant Cook Incorporated

K-Number K223098

View Details →

LYY 2022-10-28

Non Sterile Powder Free Latex Examination Glove

Applicant New Era Medicare Sdn. Bhd.

K-Number K221667

View Details →

MWI 2022-10-28

Welch Allyn Connex Central Station

Applicant Welch Allyn, Inc.

K-Number K212473

View Details →

LKF 2022-10-28

ALLY II Uterine Positioning System (UPS)

Applicant CooperSurgical, Inc.

K-Number K223064

View Details →

EBF 2022-10-28

Stela Automix System

Applicant Sdi Limited

K-Number K222581

View Details →

GAT 2022-10-27

Arthrex BioSuture

Applicant Arthrex, Inc.

K-Number K220880

View Details →

QDS 2022-10-27

FilmArray Pneumonia Panel plus

Applicant Biofire Diagnostics, LLC

K-Number K222601

View Details →

Page 959 of 2685

↑