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

IYE 2016-11-22

Raycast MammoRx Carbon Fibre Breast Board

Applicant Orfit Industries NV

K-Number K162355

View Details →

HWC 2016-11-22

ToeTac 10° Hammertoe Fixation System

Applicant Restore Surgical, LLC Dba Instratek

K-Number K161778

View Details →

HRS 2016-11-22

LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5

Applicant Aap Implantate AG

K-Number K161747

View Details →

PNR 2016-11-22

U&U Enteral Syringe

Applicant U&U Medical Technology Co, Ltd.

K-Number K160855

View Details →

MRZ 2016-11-22

WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

Applicant Welldoc, Inc.

K-Number K162225

View Details →

OVD 2016-11-22

Leva® Anterior Interbody System

Applicant Spine Wave, Inc.

K-Number K161993

View Details →

DXT 2016-11-22

Disposable High Pressure Injector Syringe

Applicant Wuxi Yushou Medical Appliances Co., Ltd.

K-Number K152906

View Details →

LIT 2016-11-22

Pirouette 014

Applicant Arravasc, Ltd.

K-Number K162316

View Details →

KRA 2016-11-22

CXI Support Catheter

Applicant Cook Incorporated

K-Number K160884

View Details →

HIH 2016-11-22

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device

Applicant Smith & Nephew, Inc.

K-Number K161763

View Details →

QEW 2016-11-22

FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator

Applicant Inari Medical

K-Number K162970

View Details →

NKG 2016-11-22

Reform® POCT System

Applicant Precision Spine, Inc.

K-Number K162300

View Details →

Page 2464 of 2685

↑