17 results · 41ms · Sources: EU EUDAMED, US FDA

Novadome

FDA registration
ICU Medical, Inc.·1 product·🇺🇸 United States

Novadome

FDA registration
ICU Medical Healthcare Manufacturing S.A. de C.V.·1 product·🇲🇽 Mexico

Smiths Medical Cath Lab Kit

FDA registration
Medline Canada·1 product·🇨🇦 Canada

DISPOSABLE DIAPHRAGM DOMES

FDA 510(k)
FDA Class 2 ·Cardiovascular

Transducer, Blood-Pressure, Extravascular

FDA classification
FDA Class 2 ·Transducer, Blood-Pressure, Extravascular

Terumo Cardiovascular Systems

FDA UDI
Med Michigan Holdings, LLC·00817278010798·Retrograde Cardioplegia Cannula, Manual Inflate...

BIOFILM, INC.

FDA registration
BIOFILM, INC.·1 product·🇺🇸 United States

COMBE INCORPORATED

FDA registration
COMBE INCORPORATED·1 product·🇺🇸 United States

I-STAT PROTHROMBIN TIME TEST

FDA registration
ABBOTT POINT OF CARE CANADA LIMITED·1 product·🇨🇦 Canada

OVATION®

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055261·OVATION® Base Rx SP 022 UL/5-5 CS-BC DHK

Partial Pelvis Replacement

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575048298·3 hole flanges

OVATION®

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055221·OVATION® Base Rx 022 UL/5-5 CS-BC DHK

OVATION®

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055241·OVATION® Base Rx 022 UL/5-5 CS-BC MHK

I-STAT PROTHROMBIN TIME TEST

FDA 510(k)
FDA Class 2 ·Hematology

LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Test, Time, Prothrombin

FDA classification
FDA Class 2 ·Test, Time, Prothrombin

Thoracolumbosacral Pedicle Screw System

FDA classification
FDA Class 2 ·Thoracolumbosacral Pedicle Screw System