10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Y-TYPE BLOOD ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
PRO
FDA UDI
Stryker GmbH·07613252731405·
ONEVIEW INTERFACE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HYGEDENT ALGINATE IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 1, 2013
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 29, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014
EVOLUT FX DCS
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NPT·November 4, 2025
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026