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

MMX 2016-02-18

Recovery Cone Removal System

Applicant C.R. Bard, Inc.

K-Number K152136

View Details →

LLZ 2016-02-17

CliniscanSM MRI

Applicant Picofemto, LLC

K-Number K153593

View Details →

CEC 2016-02-17

FREND Free T4 Test System

Applicant Nanoentek USA, Inc.

K-Number K152422

View Details →

MTJ 2016-02-17

ROP Resorbable Hemostasis Material

Applicant Resorbable Orthopedic Products, LLC

K-Number K153095

View Details →

GAR 2016-02-17

Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture

Applicant Aesculap, Inc.

K-Number K151165

View Details →

JIT 2016-02-17

ST AIA-PACK hsE2 Calibrator Set

Applicant Tosoh Bioscience, Inc.

K-Number K160113

View Details →

IPF 2016-02-17

VitalStim(R) Plus Electrotherapy System

Applicant Djo, LLC

K-Number K153224

View Details →

JFM 2016-02-16

Direct Bilirubin

Applicant Randox Laboratories Limited

K-Number K152343

View Details →

KTT 2016-02-16

D.N.E. External Fixation System

Applicant Dne, LLC

K-Number K151580

View Details →

MUJ 2016-02-16

Radiance V3

Applicant Gmv Soluciones Globales Internet S.A.U.

K-Number K153368

View Details →

DSY 2016-02-16

FUSION Vascular Graft

Applicant Maquet Cardiovascular, LLC

K-Number K153523

View Details →

LOX 2016-02-16

FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm

Applicant Ostial Corporation

K-Number K152485

View Details →

Page 2656 of 2685

↑