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

EIH 2016-04-15

Rainbow Paste Stain

Applicant Genoss

K-Number K151731

View Details →

IYO 2016-04-15

Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound

Applicant The Prometheus Group

K-Number K160792

View Details →

DKZ 2016-04-15

ACCU NEWS Drug Screening Test Card/Urine Cup

Applicant Coretests, Inc.

K-Number K152590

View Details →

KRA 2016-04-15

Bullfrog Micro-Infusion Device

Applicant Mercator Medsystems, Inc.

K-Number K153501

View Details →

BZD 2016-04-15

Simple T Pediatric Nasal Mask

Applicant Respironics, Inc.

K-Number K151120

View Details →

NHA 2016-04-15

Neodent Implant System

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S

K-Number K153624

View Details →

LNH 2016-04-15

MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K153343

View Details →

ONN 2016-04-15

VERASENSE Knee System

Applicant Orthosensor, Inc.

K-Number K150372

View Details →

MUH 2016-04-15

RIOScan (RPS500)

Applicant Ray Co., Ltd.

K-Number K160788

View Details →

ONF 2016-04-15

Forma System, Forma Light System

Applicant Formatk Systems , Ltd.

K-Number K160195

View Details →

EZL 2016-04-15

Accuryn Monitoring System

Applicant Potrero Medical, Inc.

K-Number K153655

View Details →

LON 2016-04-15

VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)

Applicant bioMerieux, Inc.

K-Number K152075

View Details →

Page 2612 of 2685

↑