Company ยท CN
Ge Hualun Medical Systems Co. , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2025. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 26, 2025 | K253269 | OEC One CFD Ge Hualun Medical Systems Co. , Ltd., CN | OXO |
| Aug 28, 2025 | K250788 | Definium Tempo Select Ge Hualun Medical Systems Co. , Ltd., CN | KPR |
| Dec 27, 2024 | K240828 | OEC One ASD Ge Hualun Medical Systems Co. , Ltd., CN | OXO |
| Oct 1, 2024 | K242678 | Definium Pace Select ET Ge Hualun Medical Systems Co. , Ltd., CN | KPR |
| Sep 12, 2023 | K231892 | Definium Pace Select Ge Hualun Medical Systems Co. , Ltd., CN | KPR |
| Jul 24, 2019 | K191699 | Discovery XR656 HD with VolumeRad Ge Hualun Medical Systems Co. , Ltd., CN | KPR |
| Nov 16, 2018 | K182626 | OEC One Ge Hualun Medical Systems Co. , Ltd., CN | OXO |
| Dec 11, 2017 | K173612 | Optima XR646 HD Ge Hualun Medical Systems Co. , Ltd., CN | KPR |
| Nov 9, 2017 | K172700 | OEC One Ge Hualun Medical Systems Co. , Ltd., CN | OWB |
| Oct 20, 2017 | K172869 | Discovery XR656 HD Ge Hualun Medical Systems Co. , Ltd., CN | KPR |
| Jul 12, 2017 | K171800 | OEC Elite MiniView Ge Hualun Medical Systems Co. , Ltd., CN | OXO |
| Feb 18, 2015 | K143270 | Optima XR646 Ge Hualun Medical Systems Co. , Ltd., CN | KPR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||