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

LIT 2018-04-12

Admiral Xtreme

Applicant Medtronic Vascular

K-Number K173515

View Details →

DQX 2018-04-11

Inno-Hydrowire

Applicant Suzhou Innomed Medical Device Co., Ltd.

K-Number K172187

View Details →

PIB 2018-04-11

IDx-DR

Applicant Idx, LLC

K-Number DEN180001

View Details →

IYO 2018-04-11

s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System

Applicant Volcano Corporation

K-Number K173860

View Details →

MQV 2018-04-11

Rafugen DBM

Applicant Cellumed Co., Ltd.

K-Number K180121

View Details →

NKG 2018-04-11

Reform® POCT System

Applicant Precision Spine, Inc.

K-Number K172495

View Details →

KYI 2018-04-11

Stablyx CMC Arthroplasty Implant System

Applicant Skeletal Dynamics, LLC

K-Number K180744

View Details →

MEH 2018-04-11

Corin TriFit CF Hip Stem

Applicant Corin U.S.A. Limited

K-Number K173880

View Details →

KPS 2018-04-11

PET Digital Gating

Applicant Ge Medical Systems, LLC

K-Number K180318

View Details →

MAI 2018-04-11

HEALIX ADVANCE Anchor with DYNACORD Suture

Applicant Medos International SARL

K-Number K173859

View Details →

PHR 2018-04-11

Riva Star

Applicant Sdi Limited

K-Number K172047

View Details →

MQF 2018-04-11

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter

Applicant Cook Incorporated

K-Number K173686

View Details →

Page 2099 of 2685

↑