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

NTE 2018-03-21

WIRION

Applicant Gardia Medical , Ltd.

K-Number K180023

View Details →

FLL 2018-03-21

ATS Thermal Imaging Probe, ATS Patient Interface Unit

Applicant Securus Medical Group, Inc.

K-Number K180148

View Details →

KGE 2018-03-21

Captura® Disposable Hot Biopsy Forceps

Applicant Wilson-Cook Medical, Inc.

K-Number K171973

View Details →

LSL 2018-03-21

cobas CT/NG for use on cobas 6800/8800 systems

Applicant Roche Molecular Systems, Inc.

K-Number K173887

View Details →

OHT 2018-03-20

Home Use IPL Beauty Device

Applicant Shenzhen Mismon Technology Co., Ltd.

K-Number K180016

View Details →

PKL 2018-03-20

Single Use Hemoclip

Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd.

K-Number K172762

View Details →

GAT 2018-03-20

ReConnex Pre-Sutured Tendon

Applicant Allosource

K-Number K170957

View Details →

JAK 2018-03-20

Philips Incisive CT

Applicant Philips Healthcare (Suzhou) Co., Ltd.

K-Number K180015

View Details →

GCJ 2018-03-20

HX Device

Applicant Human Extension , Ltd.

K-Number K173919

View Details →

ODD 2018-03-20

Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter

Applicant Wilson-Cook Medical, Inc.

K-Number K171989

View Details →

KNS 2018-03-20

Habib EndoHPB

Applicant Emcision , Ltd.

K-Number K180165

View Details →

PSZ 2018-03-20

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

Applicant Bd

K-Number K180438

View Details →

Page 2116 of 2685

↑