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

KPR 2018-05-24

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85

Applicant Samsung Electronics Co., Ltd.

K-Number K180543

View Details →

FET 2018-05-24

EPX-4440FN Digital Video Processor with Light Source

Applicant Fujifilm New Development U.S.A., Inc.

K-Number K180414

View Details →

KNS 2018-05-24

Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords

Applicant Wilson-Cook Medical Inc./Cook Endoscopy

K-Number K172665

View Details →

OAS 2018-05-24

CS 9600

Applicant Trophy

K-Number K181136

View Details →

MOB 2018-05-24

EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern

Applicant Euroimmun Us, Inc.

K-Number K172582

View Details →

EZN 2018-05-24

Safety Wire Guide Introducer

Applicant Cook Incorporated

K-Number K180756

View Details →

LLZ 2018-05-24

McKesson Cardiology

Applicant Change Healthcare Israel , Ltd.

K-Number K181080

View Details →

QBX 2018-05-24

T2Bacteria Panel

Applicant T2biosystems, Inc.

K-Number K172708

View Details →

DZE 2018-05-24

IS-III HActive Fixture

Applicant Neobiotech Co., Ltd.

K-Number K173938

View Details →

IYN 2018-05-24

Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K180862

View Details →

MQB 2018-05-24

PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

Applicant Pixxgen Corporation

K-Number K180976

View Details →

NHA 2018-05-23

Rodo Smilekey

Applicant Rodo Medical, Inc.

K-Number K180609

View Details →

Page 2127 of 2738

↑