NOVAMED-USA

FDA registration

NOVAMED-USA·1 product·🇺🇸 United States

Temp Foley

FDA registration

SEWOON MEDICAL CO., LTD.·1 product·🇰🇷 South Korea

3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheter, Retention Type, Balloon

FDA classification

FDA Class 2 ·Catheter, Retention Type, Balloon

ePlex System

FDA UDI

GENMARK DIAGNOSTICS, INC.·00857167005016·Respiratory Panel Cartridge

Ophthalmic Knife

FDA UDI

KATENA PRODUCTS, INC.·00841668113240·VITRECTOMY KNIFE 23GA (BX/5)

Embrace Pit & Fissure Sealant

FDA registration

PULPDENT CORPORATION·1 product·🇺🇸 United States

EEKAY LOGISTICS LLC

FDA registration

EEKAY LOGISTICS LLC·1 product·🇺🇸 United States

AFFINITY® NT Cardiotomy Venous Reservoir

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

CENTRIX, INC.

FDA registration

CENTRIX, INC.·1 product·🇺🇸 United States

NORTH AMERICAN WHOLESALERS LLC

FDA registration

NORTH AMERICAN WHOLESALERS LLC·1 product·🇺🇸 United States

Affinity NT Cardiotomy Venous Reservoir with Trillium Biosurface

FDA registration

MIDWEST STERILIZATION CORP.·1 product·🇺🇸 United States

Affinity CVR

FDA registration

MEDTRONIC PERFUSION SYSTEMS·1 product·🇺🇸 United States

Sterigenics US LLC

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

Sterigenics US LLC

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

WIZAIR COMPRESSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

System, Test, Low Density, Lipoprotein

FDA classification

FDA Class 1 ·System, Test, Low Density, Lipoprotein

Sleeve, Limb, Compressible

FDA classification

FDA Class 2 ·Sleeve, Limb, Compressible