15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Gems Vitrification Set, Gems Warming Set
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
V SET
FDA 510(k)
FDA Class 2
·General Hospital
V SET
FDA 510(k)
FDA Class 2
·General Hospital
V SET
FDA 510(k)
FDA Class 2
·General Hospital
SET PP
FDA 510(k)
FDA Class 2
·Dental
Patient Administration Set
FDA 510(k)
FDA Class 2
·Radiology
Towako Transmyometrial Embryo Transfer Set
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
FDA 510(k)
FDA Class 2
·General Hospital
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
FDA 510(k)
FDA Class 2
·Orthopedic
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
FDA 510(k)
FDA Class 2
·Cardiovascular
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
FDA Enforcement
Class II
·Terminated·Sirtex Medical Limited·March 24, 2021
Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C
FDA Enforcement
Class II
·Ongoing·Kico Knee Innovation Company·June 10, 2026
Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E
FDA Enforcement
Class II
·Ongoing·Kico Knee Innovation Company·June 10, 2026
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·December 18, 2024