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

EBI 2021-07-28

Pac-Dent Denture Base Resin

Applicant Pac-Dent, Inc.

K-Number K210189

View Details →

KWQ 2021-07-27

Fixxsure Anterior Lumbar Plate and Screw System

Applicant Oak Tree Engineering, LLC

K-Number K211932

View Details →

KPS 2021-07-27

PET VCAR

Applicant GE Medical Systems SCS

K-Number K211247

View Details →

PDU 2021-07-27

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

Applicant Ra Medical Systems,Inc

K-Number K210664

View Details →

LLZ 2021-07-27

aPROMISE

Applicant Exini Diagnostics AB

K-Number K211655

View Details →

DQY 2021-07-27

Rist 071 Radial Access Guide Catheter

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K211990

View Details →

HRS 2021-07-27

Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System

Applicant Integra LifeSciences Corporation

K-Number K210016

View Details →

JAA 2021-07-27

Insight Agile DRF

Applicant Imaging Engineering, LLC

K-Number K210469

View Details →

NAY 2021-07-27

Senhance Surgical System

Applicant Asensus Surgical, Inc.

K-Number K211325

View Details →

EIH 2021-07-27

1Derful HS, 1Derful HT

Applicant 1derful, Inc.

K-Number K210884

View Details →

QJP 2021-07-27

Route 92 Medical Full Length 088 Access System

Applicant Route 92 Medical, Inc.

K-Number K210635

View Details →

QIH 2021-07-27

Us2.v1

Applicant Eko.Ai Pte Ltd. D/B/A Us2.Ai

K-Number K210791

View Details →

Page 1369 of 2744

↑