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

NKB 2018-03-06

IRENE Thoracolumbar Fixation System

Applicant Tianjin Zhengtian Medical Instrument Co., Ltd.

K-Number K172267

View Details →

IPF 2018-03-06

Digitimer DS7AP Constant Current Stimulator

Applicant Digitimer , Ltd.

K-Number K172381

View Details →

OWQ 2018-03-06

Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter

Applicant Innovative Health, LLC

K-Number K173262

View Details →

KPO 2018-03-06

Citric Complete Dry Citric Acid (45X)

Applicant Dimesol USA, LLC

K-Number K171750

View Details →

LOD 2018-03-06

OrthoSteady G Bone Cement

Applicant G21, S.R.L.

K-Number K173494

View Details →

QAZ 2018-03-06

23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

Applicant 23AndMe, Inc.

K-Number DEN170046

View Details →

FDX 2018-03-05

Cytology Brush

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K172663

View Details →

NUJ 2018-03-05

Reprocessed ArthoCare Ablation Wand

Applicant Renovo, Inc.

K-Number K173741

View Details →

ODP 2018-03-05

Valeo® C+CSC with Lumen Interbody Fusion Device

Applicant Amedica Corp.

K-Number K173453

View Details →

KTT 2018-03-05

DePuy Synthes Femoral Neck System

Applicant DePuy Synthes

K-Number K172872

View Details →

FPA 2018-03-05

MiniMed Mio Advance infusion set

Applicant Unomedical A/S

K-Number K173879

View Details →

HTY 2018-03-05

HammerTube System

Applicant Paragon 28

K-Number K171715

View Details →

Page 2128 of 2685

↑