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

MQL 2018-08-29

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set

Applicant Shenzhen Vitavitro Bio-Tech Co., Ltd.

K-Number K180073

View Details →

LLZ 2018-08-29

Change Healthcare Enterprise Viewer

Applicant Change Healthcare Canada Company

K-Number K181185

View Details →

OVE 2018-08-29

Genesys Spine AIS-C Cervical Stand-Alone System

Applicant Genesys Spine

K-Number K181295

View Details →

KWL 2018-08-29

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement

Applicant Osteoremedies, LLC

K-Number K172906

View Details →

HIH 2018-08-29

TruClear Elite Hysteroscope

Applicant Covidien

K-Number K180496

View Details →

BZR 2018-08-29

Equinox Advantage

Applicant O-Two Medical Technologies, Inc.

K-Number K173205

View Details →

LCJ 2018-08-29

Natrelle 133S Tissue Expander

Applicant Allergan

K-Number K182054

View Details →

OWI 2018-08-29

ResCUBE Ligament Fixation System

Applicant Cousin Biotech Sas

K-Number K181799

View Details →

FMI 2018-08-28

Disposable Insulin Pen Needle

Applicant Zhejiang Kindly Medical Devices Co., Ltd.

K-Number K181069

View Details →

DPS 2018-08-28

Universal SmartECG

Applicant Vectracor, Inc.

K-Number K173952

View Details →

LFL 2018-08-28

Tenex Health TX System with the TXP MicroTip

Applicant Tenex Health, Inc.

K-Number K181367

View Details →

PMN 2018-08-28

BD MAX CT/GC/TV 20-Day QC Panel

Applicant Microbiologics, Inc.

K-Number K181683

View Details →

Page 2003 of 2685

↑