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

LFC 2020-03-11

Vista Dyes

Applicant Inter-Med/Vista Dental Products

K-Number K193447

View Details →

DKZ 2020-03-11

Quidel Triage® TOX Drug Screen, 94600

Applicant Quidel Cardiovascular, Inc.

K-Number K200363

View Details →

MAI 2020-03-11

Fixone Biocomposite Anchor

Applicant Aju Pharm Co., Ltd.

K-Number K192484

View Details →

MBI 2020-03-11

Apollo Suture Anchor System

Applicant Valeris Medical

K-Number K192810

View Details →

MRN 2020-03-10

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System

Applicant International Biomedical

K-Number K193481

View Details →

GEX 2020-03-10

Bare: 808

Applicant Luvo Medical Technologies, Inc.

K-Number K193446

View Details →

PGW 2020-03-10

FlexPointer 1.5 Single Use, FlexTube 3 Single Use

Applicant Fiagon GmbH

K-Number K200041

View Details →

OZE 2020-03-10

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

Applicant Centers for Disease Control and Prevention

K-Number K200370

View Details →

KGO 2020-03-10

JR.MEDIK Latex Surgeons Gloves Powder Free

Applicant Jr Engineering & Medical Technologies (M) Sdn. Bhd.

K-Number K192328

View Details →

GEX 2020-03-10

Rapid Acoustic Pulse Device

Applicant Soliton, Inc.

K-Number K200331

View Details →

IZF 2020-03-09

DR 600 with Tomosynthesis

Applicant Agfa N.V.

K-Number K193262

View Details →

MPN 2020-03-09

LiquiBand Plus

Applicant Advanced Medical Solutions Limited

K-Number K183570

View Details →

Page 1629 of 2685

↑