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Data / Medical devices / United States / Anodyne Surgical

Anodyne Surgical: FDA-registered device maker in O Fallon, MO, United States, 1 510(k) clearance

Anodyne Surgical is registered with the FDA (registration 1929756) in O Fallon, MO, United States. It lists 25 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 13, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Anodyne Surgical
FDA registration number
1929756
Address
804 Corporate Centre Dr, O Fallon, MO, United States, 63368
Owner or operator
PSI/EYE-KO, INC. (1929756)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
January 4, 1993
Registered through
2026
Brand names listed
Anodyne Surgical Caliper, ophthalmic, Anodyne Surgical Dilator, lachrymal, Anodyne Surgical Forceps, ophthalmic, Anodyne Surgical Handle, Scalpel, Anodyne Surgical Marker, ocular, Anodyne Surgical PVA Spears, Anodyne Surgical Scissors, Ophthalmic, Anodyne Surgical Tray, Surgical and more

Devices it lists

DeviceProduct codeClassRoleSource
Caliper, OphthalmicHOE1Repackager or relabeleraccessdata.fda.gov
Cannula, OphthalmicHMX1Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalMXY1Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, Trocar, OphthalmicNGY1Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF2Contract manufactureraccessdata.fda.gov
CystotomeHNY1Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Irrigation, Ocular SurgeryKYG1Contract manufacturer, Manufactureraccessdata.fda.gov
Dilator, LachrymalHNW1Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Hook, OphthalmicHNQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Knife, OphthalmicHNN1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Lacrimal Stents And Intubation SetsOKSUManufactureraccessdata.fda.gov
Marker, OcularHMR1Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Contract manufacturer, Manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Contract manufacturer, Manufactureraccessdata.fda.gov
Probe, LachrymalHNL1Contract manufacturer, Manufactureraccessdata.fda.gov
Retractor, OphthalmicHNI1Contract manufacturer, Manufactureraccessdata.fda.gov
Scissors, OphthalmicHNF1Repackager or relabeleraccessdata.fda.gov
Snare, SurgicalGAE1Contract manufacturer, Manufactureraccessdata.fda.gov
Spatula, OphthalmicHND1Contract manufacturer, Manufactureraccessdata.fda.gov
Specula, OphthalmicHNC1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Sponge, OphthalmicHOZ2Repackager or relabeleraccessdata.fda.gov
Surgical Eye TrayPZG1Manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 13, 2016K160710Oasis Lacrimal Intubation SetOKSUnknownAnodyneaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 21, 202187795Class IITerminatedHydrodissection 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 WalcoThe product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.accessdata.fda.gov

Compare with other makers

Updated May 13, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.