12 results
·
25ms
·
Sources: EU EUDAMED, US FDA
STORC INTRAUTERINE PRESSURE CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
K-DEFIB/PACE ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
CONSUMER SENSORY PRODUCTS BIO-LOG 8000
FDA 510(k)
FDA Class 2
·General Hospital
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·June 16, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·February 11, 2013
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011
UNKNOWN TRIFLANGE CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·July 24, 2014
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
FDA Enforcement
Class II
·Terminated·Ra Medical Systems Inc·August 6, 2014
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024