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

LLZ 2016-09-21

CAAS MRV

Applicant Pie Medical Imaging BV

K-Number K162112

View Details →

GEX 2016-09-21

Sterling 5W Diode Laser

Applicant CAO Group, Inc.

K-Number K160413

View Details →

FMI 2016-09-21

CPL Insulin Pen Needle

Applicant Cpl Co., Ltd.

K-Number K151090

View Details →

NRY 2016-09-21

Solitaire Platinum Revascularization Device

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

K-Number K161879

View Details →

DTZ 2016-09-21

Affinity NT Oxygenator with Cortiva BioActive Surface

Applicant Medtronic, Inc.

K-Number K162016

View Details →

NKG 2016-09-21

QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments

Applicant Globus Medical, Inc.

K-Number K161591

View Details →

HRS 2016-09-21

ARIX Hand System

Applicant Jeil Medical Corporation

K-Number K161746

View Details →

BZD 2016-09-20

F&P Eson 2 Nasal Mask

Applicant Fisher & Paykel Healthcare Limited

K-Number K153505

View Details →

DRA 2016-09-20

Hansen Medical Magellan Robotic Catheter 9Fr

Applicant Hansen Medical, Inc.

K-Number K160919

View Details →

NUJ 2016-09-20

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)

Applicant Sterilmed, Inc.

K-Number K161086

View Details →

CDD 2016-09-20

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set

Applicant Diazyme Laboratories

K-Number K161721

View Details →

DQX 2016-09-20

Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip

Applicant Volcano Corporation

K-Number K161887

View Details →

Page 2563 of 2738

↑