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US
Last updated May 23, 2026
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- US
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Catalogue (258)
Page 2 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GeniSurge | 533-005-930 | FDA UDI | Class II | Active |
| Natura | 210-015-150 | FDA UDI | Class I | Active |
| GeniShield | 100-110-191 | FDA UDI | Class I | Active |
| GeniSurge | 533-005-910 | FDA UDI | Class II | Active |
| Natura | 210-005-151 | FDA UDI | Class I | Active |
| GeniLook | 200-012-151 | FDA UDI | Class I | Active |
| GeniLook | 200-108-151 | FDA UDI | Class I | Active |
| Natura | 210-012-151 | FDA UDI | Class I | Active |
| GeniLook | 200-015-250 | FDA UDI | Class I | Active |
| Probe | 707-005-333 | FDA UDI | Class II | Active |
| GeniLook | 200-005-252 | FDA UDI | Class I | Active |
| Natura | 210-105-252 | FDA UDI | Class I | Active |
| Natura | 210-110-152 | FDA UDI | Class I | Active |
| Kit | 120-105-192 | FDA UDI | Class I | Active |
| Aquas Powerflow | 720-005-003 | FDA UDI | Class II | Unknown |
| GeniSurge | 533-005-920 | FDA UDI | Class II | Active |
| X-Surge | 590-005-005 | FDA UDI | Class II | Active |
| GeniPort | 100-005-000 | FDA UDI | Class I | Active |
| GeniLook | 200-110-251 | FDA UDI | Class I | Active |
| Natura | 210-005-252 | FDA UDI | Class I | Active |
| Natura | 210-115-251 | FDA UDI | Class I | Active |
| GeniLook | 200-105-152 | FDA UDI | Class I | Active |
| GeniStrong | 550-000-011G | FDA UDI | Class II | Active |
| GeniPalm | 100-105-052 | FDA UDI | Class I | Active |
| GeniPalm | 100-005-050 | FDA UDI | Class I | Active |
| GeniStrong | 550-000-005G | FDA UDI | Class II | Active |
| Natura | 210-105-051 | FDA UDI | Class I | Active |
| GeniLook | 200-015-150 | FDA UDI | Class I | Active |
| GeniShield | 100-105-191 | FDA UDI | Class I | Active |
| Probe | 707-005-133 | FDA UDI | Class II | Active |
| GeniSurge | FX-533-005-910 | FDA UDI | Class II | Active |
| NanoSurge | 520-063-920 | FDA UDI | Class I | Active |
| Cannula | 100-005-921 | FDA UDI | Class I | Active |
| BiSurge | 620-163-920 | FDA UDI | Class I | Active |
| GeniClip Applier | 350-010-002 | FDA UDI | Class I | Active |
| Natura | 210-005-052 | FDA UDI | Class I | Active |
| GeniShield | 100-110-192 | FDA UDI | Class I | Active |
| BiSurge | 628-163-950 | FDA UDI | Class I | Active |
| Natura | 210-010-250 | FDA UDI | Class I | Active |
| Cannula | 100-110-201 | FDA UDI | Class I | Active |
| Cannula | 100-112-001 | FDA UDI | Class I | Active |
| Natura | 210-012-150 | FDA UDI | Class I | Active |
| NanoSurge | 520-063-945 | FDA UDI | Class I | Active |
| Aquas Powerflow | 720-005-000 | FDA UDI | Class II | Unknown |
| GeniSurge | 533-005-905T | FDA UDI | Class II | Active |
| NanoSurge | 520-063-910 | FDA UDI | Class II | Active |
| NanoSurge | 528-063-910 | FDA UDI | Class I | Active |
| Probe | 700-005-033 | FDA UDI | Class II | Active |
| GeniLook | 200-105-252 | FDA UDI | Class I | Active |
| Natura | 210-005-252 | FDA UDI | Class I | 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. |