21 results
·
44ms
·
Sources: EU EUDAMED, US FDA
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code GBO·May 19, 2021
EVO/EVO + VISIAN IMPLANTABLE COLLAMER LENS (ICL)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code QCB·November 10, 2025
Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
FDA Recall
Terminated
·Product code ECO·May 1, 2018
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Recall
Open, Classified
·CELLTRION USA INC·Product code QKP·February 25, 2022
Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from commencing irradiation while any parameter is out of conformance with the treatment plan.
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code IYE·June 2, 2008
Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
FDA Recall
Terminated
·Varian Medical Systems Inc.·Product code IYE·July 20, 2010
Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treatment planning systems; Model Number: H51; Reference/PSCA Identifier: CP-03063; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·June 27, 2011
The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The 4D Integrated Treatment Console function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·February 28, 2011