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

EZD 2018-06-14

COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter

Applicant Compactcath, Inc.

K-Number K180738

View Details →

JXG 2018-06-14

Smart External Drain (SED) System

Applicant Aqueduct Critical Care, Inc.

K-Number K181301

View Details →

GEX 2018-06-14

InMode Diolaze System

Applicant Inmode MD , Ltd.

K-Number K180719

View Details →

GMQ 2018-06-14

ASI Evolution

Applicant Arlington Scientific, Inc. (Asi)

K-Number K173376

View Details →

LNH 2018-06-14

MRIaudio PREM System

Applicant Mriaudio

K-Number K180100

View Details →

LZA 2018-06-14

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)

Applicant Hartalega Sdn Bhd

K-Number K180505

View Details →

ODP 2018-06-14

TiWAVE-C Porous Titanium Cervical Cage

Applicant Kalitec Direct, LLC

K-Number K180401

View Details →

FMI 2018-06-14

Disposable Sterile Needle

Applicant Jiangsu Caina Medical Co.,Ltd

K-Number K172938

View Details →

FHN 2018-06-14

Ligation Device

Applicant Leo Medical Co., Ltd.

K-Number K172985

View Details →

DQX 2018-06-14

Double Flexible Tipped Wire Guides

Applicant Cook Incorporated

K-Number K181351

View Details →

DQK 2018-06-14

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

Applicant Biosense Webster, Inc.

K-Number K173977

View Details →

GWQ 2018-06-14

Natus Brain Monitor Amplifier

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

K-Number K180290

View Details →

Page 2053 of 2685

↑