15 results · 20ms · Sources: EU EUDAMED, US FDA

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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