Anodyne Surgical
O Fallon, MO, US
ANODYNE SURGICAL appears in FDA device records in O Fallon, MO. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1929756 | 1929756 | ANODYNE SURGICAL | 804 Corporate Centre Dr, O Fallon, MO 63368 US | 2026 | and 15 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HOECaliper, Ophthalmic
- HMXCannula, Ophthalmic
- MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
- NGYCannula, Trocar, Ophthalmic
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- HNYCystotome
- KYGDevice, Irrigation, Ocular Surgery
- HNWDilator, Lachrymal
- HNRForceps, Ophthalmic
- GDZHandle, Scalpel
- HNQHook, Ophthalmic
- HNNKnife, Ophthalmic
- OKSLacrimal Stents And Intubation Sets
- HMRMarker, Ocular
- GAANeedle, Aspiration And Injection, Disposable
- GDMNeedle, Aspiration And Injection, Reusable
- HNLProbe, Lachrymal
- HNIRetractor, Ophthalmic
- HNFScissors, Ophthalmic
- GAESnare, Surgical
- HNDSpatula, Ophthalmic
- HNCSpecula, Ophthalmic
- HOZSponge, Ophthalmic
- PZGSurgical Eye Tray
- LRPTray, Surgical
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1852-2021 | Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300 | The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain