3 results
·
6ms
·
Sources: EU EUDAMED, US FDA
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
FDA Enforcement
Class II
·Ongoing·WOM World Of Medicine AG·October 4, 2023
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
FDA Enforcement
Class II
·Ongoing·Synthes USA HQ, Inc.·August 7, 2013
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Corp. Hq.)·October 2, 2024