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

MYA 2017-12-21

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)

Applicant Dako Denmark A/S

K-Number K170028

View Details →

GDW 2017-12-21

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use

Applicant Ezisurg Medical Co., Ltd.

K-Number K172960

View Details →

KWQ 2017-12-21

Anterior Cervical Plate System

Applicant Evolution Spine, LLC

K-Number K173375

View Details →

MXZ 2017-12-21

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)

Applicant Dako Denmark A/S

K-Number K170005

View Details →

DRC 2017-12-21

SafeSept Needle Free Transseptal Guidewire

Applicant Pressure Products Medical Device Manufacturing, LLC

K-Number K172893

View Details →

MQP 2017-12-20

T2 STRATOSPHERE™ Expandable Corpectomy System

Applicant Medtronic Sofamor Danek

K-Number K173125

View Details →

HGX 2017-12-20

Electric Breast Pump

Applicant Joytech Healthcare Co. , Ltd.

K-Number K172989

View Details →

IYN 2017-12-20

LOGIQ E10

Applicant GE Healthcare

K-Number K173555

View Details →

KIF 2017-12-20

Well-Root ST

Applicant Vericom Co., Ltd.

K-Number K170950

View Details →

ODP 2017-12-20

COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS

Applicant Globus Medical, Inc.

K-Number K173115

View Details →

HSB 2017-12-20

Apex Tibial Nailing System

Applicant Orthoxel

K-Number K170972

View Details →

DYB 2017-12-20

Sentrant Introducer Sheath with Hydrophilic Coating

Applicant Medtronic Vascular, Inc.

K-Number K171866

View Details →

Page 2235 of 2738

↑