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

GEH 2019-12-20

IceSense 3, ProSense, MultiSense

Applicant IceCure Medical , Ltd.

K-Number K183213

View Details →

KPR 2019-12-20

DRX-Evolution with Carestream Digital Tomosynthesis

Applicant Carestream Health, Inc.

K-Number K191879

View Details →

NXC 2019-12-20

DenMat Orthodontic Aligners

Applicant Denmat Holdings, LLC

K-Number K192470

View Details →

LXH 2019-12-20

SX-One MicroKnife

Applicant Sonex Health, Inc.

K-Number K192873

View Details →

EBF 2019-12-20

R&D Series Nova Compo N

Applicant Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

K-Number K192178

View Details →

GEX 2019-12-20

Soli-Lite LG4 Galileo

Applicant Silhouet-Tone Corporation

K-Number K192755

View Details →

CDZ 2019-12-20

ACTIVE® Free Testosterone RIA

Applicant Immunotech S.R.O.

K-Number K191350

View Details →

SBF 2019-12-20

xvision Spine system (XVS)

Applicant Augmedics, Ltd.

K-Number K190929

View Details →

MQC 2019-12-20

Ceramill A-Splint

Applicant Amann Girrbach AG

K-Number K191836

View Details →

GEI 2019-12-20

APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets

Applicant Erbe Elektromedizin GmbH

K-Number K191234

View Details →

QEW 2019-12-20

Indigo Aspiration System

Applicant Penumbra, Inc.

K-Number K192833

View Details →

FRO 2019-12-20

IODOSORB

Applicant Smith & Nephew Medical, Ltd.

K-Number K190730

View Details →

Page 1747 of 2744

↑