Company
WOM World of Medicine AG
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2024 | WOM World Of Medicine AG WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc.
REF Numbers: T0449-01 Open, Classified |
HRX | K062380 |
| Jan 5, 2024 | WOM World Of Medicine AG 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 flowi Open, Classified |
HIG | K172040 |
| Jun 18, 2021 | WOM World of Medicine AG Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000 Open, Classified |
HIG | K173489 |
| Aug 14, 2019 | WOM World of Medicine AG Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS
Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies. Terminated |
HIG | K172040 |
| Oct 22, 2018 | WOM World of Medicine AG PNEUMOCLEAR Heated High-Flow Tube Set
Product Usage:
The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. Terminated |
HIF | K170784 |