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

ODP 2016-03-02

PERIMETER C (Titanium) Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K153438

View Details →

ILY 2016-03-02

BioPhotas Celluma3

Applicant Biophotas, Inc.

K-Number K152280

View Details →

KNS 2016-03-02

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215

Applicant Olympus Medical Systems Corp.

K-Number K160241

View Details →

OUR 2016-03-01

iFuse Implant System(R)

Applicant SI-BONE, Inc.

K-Number K152681

View Details →

LYZ 2016-03-01

Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves

Applicant Xinfu Medical Products Co., Ltd.

K-Number K152719

View Details →

KDI 2016-03-01

xevonta dialyzer

Applicant B. Braun Avitum AG

K-Number K143482

View Details →

OLO 2016-03-01

OrthAlign Plus System

Applicant Orthalign, Inc.

K-Number K153237

View Details →

MCW 2016-03-01

Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)

Applicant Avinger, Inc.

K-Number K153460

View Details →

GCJ 2016-03-01

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm

Applicant Covidien

K-Number K160230

View Details →

BSO 2016-03-01

SPINAUT-E, SPINAUT-I

Applicant Imedicom Co., Ltd.

K-Number K150789

View Details →

LEJ 2016-03-01

3400E series; E5400 series; E6400 series; Sundazzler series

Applicant Heartland Tanning, Inc.

K-Number K151905

View Details →

LNH 2016-03-01

Wrist 3

Applicant Aspect Imaging, Ltd.

K-Number K160185

View Details →

Page 2646 of 2685

↑