13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ROP Resorbable Hemostasis Material
FDA 510(k)
FDA Unclassified
·Unknown
HONEY ALGINATE DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
FDA 510(k)
FDA Class 2
·Cardiovascular
ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM
FDA Adverse Event
Injury
·LDR MEDICAL·Product code OVD·November 13, 2019
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 8, 2013
ASR UNI FEMORAL IMPL SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 12, 2011
ACCU-THERM
FDA Adverse Event
Malfunction
·MEDLINE INDUSTRIES, INC.·Product code IMD·September 8, 2008
SENTRANT INTRODUCER SHEATH
FDA Adverse Event
Injury
·MEDTRONIC VASCULAR·Product code DYB·May 18, 2026
ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·April 23, 2019
ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·January 27, 2023
ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code MAX·May 13, 2023
DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023