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

MEG 2016-08-19

0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle

Applicant Sol-Millennium Medical, Inc.

K-Number K162030

View Details →

NBW 2016-08-19

Wireless Smart Gluco-Monitoring System

Applicant Andon Health Co, Ltd.

K-Number K153278

View Details →

PBX 2016-08-19

InMode System MiniFX Handpiece

Applicant Inmode MD , Ltd.

K-Number K160329

View Details →

KRA 2016-08-18

Bullfrog Micro-Infusion Device

Applicant Mercator Medsystems, Inc.

K-Number K161402

View Details →

FPA 2016-08-18

PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set

Applicant C.R. Bard, Inc.

K-Number K153440

View Details →

JOW 2016-08-18

Reprocessed Compression Garments

Applicant Covidien

K-Number K161105

View Details →

IYN 2016-08-18

SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K162045

View Details →

JLW 2016-08-18

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

Applicant Beckman Coulter, Inc.

K-Number K153651

View Details →

DXC 2016-08-18

Vein Clamps, Artery Clamps

Applicant Aros Surgical Instruments Corporation

K-Number K161315

View Details →

DQX 2016-08-18

S-Wire Guidewire System

Applicant Concert Medical, LLC

K-Number K153397

View Details →

DQA 2016-08-18

Fingertip Pulse Oximeter

Applicant Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.

K-Number K152091

View Details →

OCC 2016-08-18

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

Applicant Alere Scarborough, Inc.

K-Number K161375

View Details →

Page 2585 of 2738

↑