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US
Last updated May 23, 2026
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- US
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Catalogue (258)
Page 5 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aquas Powerflow | 720-005-002 | FDA UDI | Class II | Unknown |
| GeniLook | 200-005-050 | FDA UDI | Class I | Active |
| Natura | 210-005-051 | FDA UDI | Class I | Active |
| SimplyStrong | 550-000-010 | FDA UDI | Class II | Active |
| GeniPort | 100-105-101 | FDA UDI | Class I | Active |
| Natura | 210-110-151 | FDA UDI | Class I | Active |
| GeniFlow | 700-000-010 | FDA UDI | Class II | Active |
| BiSurge | 633-005-950 | FDA UDI | Class II | Active |
| Probe | 707-010-033 | FDA UDI | Class II | Active |
| GeniShield | 100-105-192 | FDA UDI | Class I | Active |
| BiSurge | 633-105-920 | FDA UDI | Class II | Active |
| GeniPort | 100-005-001 | FDA UDI | Class I | Active |
| Natura | 210-112-151 | FDA UDI | Class I | Active |
| GeniClip | 350-000-101 | FDA UDI | Class II | Active |
| Cannula | 100-115-001 | FDA UDI | Class I | Active |
| Natura | 210-005-150 | FDA UDI | Class I | Active |
| GeniStrong | 550-000-009G | FDA UDI | Class II | Active |
| GeniSurge | 533-005-935 | FDA UDI | Class II | Active |
| GeniSurge | 533-005-915T | FDA UDI | Class II | Active |
| GeniLook | 200-005-052 | FDA UDI | Class I | Active |
| Simply EZee | 550-000-027 | FDA UDI | Class II | Active |
| GeniPalm | 100-012-151 | FDA UDI | Class I | Active |
| Natura | 210-015-151 | FDA UDI | Class I | Active |
| GeniClip | 350-000-103 | FDA UDI | Class II | Active |
| Natura | 210-105-052 | FDA UDI | Class I | Active |
| Natura | 210-105-152 | FDA UDI | Class I | Active |
| GeniLook | 200-005-152 | FDA UDI | Class I | Active |
| GeniSurge | 533-105-910 | FDA UDI | Class II | Active |
| Cannula | 100-115-201 | FDA UDI | Class I | Active |
| Cannula | 100-105-901 | FDA UDI | Class I | Active |
| Hasson | 400-012-131 | FDA UDI | Class I | Active |
| GeniLook | 200-110-151 | FDA UDI | Class I | Active |
| GeniSurge | FX-533-005-920 | FDA UDI | Class II | Active |
| GeniFlow | 700-005-005 | FDA UDI | Class II | Active |
| GeniSurge | 533-005-915 | FDA UDI | Class II | Active |
| Natura | 210-005-050 | FDA UDI | Class I | Active |
| GeniLook | 200-005-051 | FDA UDI | Class I | Active |
| GeniPort | 100-005-100 | FDA UDI | Class I | Active |
| GeniClip Applier | 350-010-000 | FDA UDI | Class I | Active |
| GeniFlow | 710-300-000 | FDA UDI | Class II | Active |
| GeniPort | 100-005-101 | FDA UDI | Class I | Active |
| Cannula | 100-105-921 | FDA UDI | Class I | Active |
| GeniLook | 200-105-251 | FDA UDI | Class I | Active |
| GeniShield | 100-010-192 | FDA UDI | Class I | Active |
| Cap | 100-010-744 | FDA UDI | Class I | Active |
| BiSurge | 633-105-950 | FDA UDI | Class II | Active |
| NanoSurge | 528-063-945 | FDA UDI | Class I | Active |
| Aquas Probes | K190168 | FDA 510(k) | Class II | Active |
| Ezee Retrieval | K162059 | FDA 510(k) | Class II | Active |
| Genicon Suction Irrigation System | K041967 | FDA 510(k) | Class II | Active |
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FDA Recalls (18)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 17, 2020 | Z-0310-2021 | — | open, classified | Device malfunction causing the applier to jam, and clip loading failures. |
| Aug 25, 2020 | Z-0094-2021 | — | open, classified | The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k). |
| Aug 21, 2018 | Z-2267-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2269-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2271-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2270-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2272-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2274-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2268-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2277-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2266-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2276-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2279-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2275-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2273-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Aug 21, 2018 | Z-2278-2020 | — | open, classified | There is potential for the plastic optical tip to become detached from the metal shaft. |
| Jun 27, 2018 | Z-2005-2020 | — | open, classified | Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval. |
| Jul 19, 2017 | Z-1076-2018 | — | terminated | Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. |