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

LCX 2019-04-15

WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream

Applicant Wholepower Biotech Co., Ltd.

K-Number K190705

View Details →

NLQ 2019-04-15

Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis

Applicant Sterilmed, Inc.

K-Number K182272

View Details →

DTZ 2019-04-13

INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir

Applicant Sorin Group Italia S.R.L.

K-Number K190690

View Details →

LCP 2019-04-12

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

Applicant Ixensor Co, Ltd.

K-Number K181915

View Details →

PSW 2019-04-12

TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants

Applicant Cs Medical, LLC

K-Number K182891

View Details →

MUJ 2019-04-12

RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review

Applicant Brainlab AG

K-Number K190664

View Details →

LLZ 2019-04-12

InstaRISPACS / InstaZFP / InstaMobi v5.0

Applicant Meddiff Technologies Pvt. , Ltd.

K-Number K182572

View Details →

HRS 2019-04-12

MIS Bunion Plating System

Applicant Crossroads Extremity Systems, LLC

K-Number K190658

View Details →

MOS 2019-04-12

3T 32 Channel Head Coil

Applicant Nova Medical, Inc.

K-Number K182737

View Details →

BTY 2019-04-12

Ascent Cardiorespiratory Diagnostic Software

Applicant Medical Graphics Corporation

K-Number K181912

View Details →

JAK 2019-04-12

Deep Learning Image Reconstruction

Applicant Ge Medical Systems, LLC

K-Number K183202

View Details →

DXH 2019-04-12

KardiaMobile, KardiaStation

Applicant AliveCor, Inc.

K-Number K182396

View Details →

Page 1851 of 2685

↑