Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

KNG 2019-11-14

HeraBEAT™ US

Applicant Heramed, Ltd.

K-Number K191110

View Details →

OLO 2019-11-14

Brainlab Compatible K2M Navigation Instruments

Applicant K2m, Inc.

K-Number K192911

View Details →

MQF 2019-11-14

Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)

Applicant Allwin Medical Devices, Inc.

K-Number K190522

View Details →

MAX 2019-11-14

LongBow Ti

Applicant Life Spine, Inc.

K-Number K190721

View Details →

NAY 2019-11-14

E-100 Electrosurgical Generator, SynchroSeal

Applicant Intuitive Surgical, Inc.

K-Number K191280

View Details →

OVE 2019-11-13

AEON-C Stand Alone System

Applicant Huvexel Co. , Ltd.

K-Number K191477

View Details →

OVE 2019-11-13

NuVasive CoRoent Small Interlock System

Applicant Nu Vasive, Incorporated

K-Number K192582

View Details →

OLZ 2019-11-13

Nox Sleep System

Applicant Nox Medical

K-Number K192469

View Details →

FMI 2019-11-13

Piper GO-IO Intraosseous Infusion System

Applicant Piper Access, LLC

K-Number K191976

View Details →

QIH 2019-11-13

EchoGo Core

Applicant Ultromics, Ltd.

K-Number K191171

View Details →

LKN 2019-11-13

AMICUS Separator System

Applicant Fresenius Kabi AG

K-Number K192150

View Details →

FLL 2019-11-13

Infrared Thermometer Model MD-H30

Applicant Guangzhou Berrcom Medical Device Co., Ltd.

K-Number K191570

View Details →

Page 1777 of 2744

↑