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

BTT 2016-05-03

HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010

Applicant Hamilton Medical AG

K-Number K152029

View Details →

OVD 2016-05-03

ENZA Zero-Profile Anterior Interbody Fusion

Applicant Camber Spine Technologies

K-Number K153720

View Details →

DKZ 2016-05-03

UCP COMPACT DRUG TESTS

Applicant Ucp Biosciences, Inc.

K-Number K152908

View Details →

DYG 2016-05-03

Swan Ganz Catheters

Applicant Edwards Lifesciences, LLC

K-Number K160084

View Details →

GEI 2016-05-03

SERFAS 90-S Electrosurgical Probe

Applicant Stryker Corporation

K-Number K160050

View Details →

MBI 2016-05-03

STROPP (Single Tunnel Repair of Plantar Plate)

Applicant Crossroads Extremity Systems, LLC

K-Number K160118

View Details →

MXZ 2016-05-03

FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)

Applicant Dako North America, Inc.

K-Number K160922

View Details →

HQF 2016-05-02

Green Laser Photocoagulator GYC-500

Applicant Nidek Co., Ltd.

K-Number K152603

View Details →

GDJ 2016-05-02

Standard Clamp

Applicant Standard Bariatrics

K-Number K153358

View Details →

BZD 2016-05-02

AirFit N20

Applicant Resmed, Ltd.

K-Number K153673

View Details →

IYN 2016-05-02

TRINITY

Applicant Koelis

K-Number K160357

View Details →

PGY 2016-05-02

MX50T(MX50TQS)

Applicant Wide Corporation

K-Number K160354

View Details →

Page 2602 of 2685

↑