15 results
·
35ms
·
Sources: EU EUDAMED, US FDA
SEA - PORT INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515225732·Oral Surgery Exodontia Elevator, #34
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533305·Articulating surface, vitamin E highly crosslin...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533329·Articulating surface, vitamin E highly crosslin...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533275·Articulating surface, vitamin E highly crosslin...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533282·Articulating surface, vitamin E highly crosslin...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533299·Articulating surface, vitamin E highly crosslin...
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575533312·Articulating surface, vitamin E highly crosslin...
CARDIAC MINISCOPE & MINIGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDRAD INTEGO PET INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 30, 2014
REPLY
FDA Adverse Event
Injury
·SORIN BIOMEDICA CRM S.R.L.·Product code NVZ·October 19, 2010
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·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
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017