14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EDS Universal Cement
FDA 510(k)
FDA Class 2
·Dental
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100615·KATENA DOUBLE-X SPECULUM K-WIRE
BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
APOLLO GENERATOR
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code GWG·June 11, 2015
SYRINGE 30ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 27, 2025
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 8, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 7, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·March 13, 2018
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 3, 2018
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·May 22, 2018
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Enforcement
Class II
·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019