12 results · 27ms · Sources: EU EUDAMED, US FDA

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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