12 results
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27ms
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Sources: EU EUDAMED, US FDA
ARGYLE SILICONE THORACIC CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113318·PHACO KNIFE 1.8MM ANGLED (BX/5)
UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
CENTRICITY PACS IW
FDA 510(k)
FDA Class 2
·Radiology
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·October 5, 2007
STATSPIN EXPRESS 4
FDA Adverse Event
Malfunction
·IRIS INTERNATIONAL·Product code JQC·February 21, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·October 23, 2012
PERIARTICULAR AIMING ARM FOR 4.5MM LCP PROX TIBIA PL-RT
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code FZX·February 23, 2015
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·October 14, 2015
BARDIA® FOLEY CATHETER SILICONE COATED
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code KOD·May 23, 2024
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
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015