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

DQX 2019-07-22

Roadrunner PC Wire Guide, Olcott Torque Device

Applicant Cook Incorporated

K-Number K182985

View Details →

DQY 2019-07-20

CerusEndo Microcatheter

Applicant Cerus Endovascular, Inc.

K-Number K182487

View Details →

DQK 2019-07-20

CARTO 3 EP Navigation System, Version 7.1 and Accessories

Applicant Biosense Webster, Inc.

K-Number K191660

View Details →

JGS 2019-07-19

Stat Profile Prime ES Comp Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K191365

View Details →

HBE 2019-07-19

Anspach Helix Dissection Tools

Applicant The Anspach Effort, Inc.

K-Number K183545

View Details →

QAI 2019-07-19

Exceed Microneedling device

Applicant Mt. Derm GmbH

K-Number K182407

View Details →

OVB 2019-07-19

SpaceOAR Vue Hydrogel

Applicant Augmenix, Inc.

K-Number K182971

View Details →

KDI 2019-07-19

Surdial DX Hemodialysis System

Applicant Nipro Medical Corporation

K-Number K182940

View Details →

PBH 2019-07-19

KIDScore D3

Applicant Vitrolife A/S

K-Number K182798

View Details →

NQQ 2019-07-19

NvisionVLE Low-profile Optical Probe

Applicant Ninepoint Medical, Inc.

K-Number K191117

View Details →

IYN 2019-07-19

Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0

Applicant Canon Medical Systems Corporation

K-Number K191467

View Details →

GBM 2019-07-19

Infyna Chic

Applicant Hollister Incorporated

K-Number K191633

View Details →

Page 1787 of 2685

↑