16 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CAL/RAD UPGRADE MODEL 1030
FDA 510(k)
FDA Class 2
·Radiology
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256679·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256631·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256693·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256655·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256662·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256686·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256648·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256624·Articulating Surfaces, CCK
ATLANTIS PVIMAGING CATHETER, MODEL H749364560
FDA 510(k)
FDA Class 2
·Radiology
Saniclave 250
FDA 510(k)
FDA Class 2
·General Hospital
DIMENSION(R) CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code JJE·June 18, 2014
MEMBRAGEL
FDA Adverse Event
Injury
·BIORA AB·Product code NPK·October 19, 2010
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 19, 2012
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020