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Data / Medical devices / United States / Synergetics, Inc.

Synergetics, Inc.: FDA-registered device maker in O Fallon, MO, United States, 10 510(k) clearances

Synergetics, Inc. is registered with the FDA (registration 1932402) in O Fallon, MO, United States. It lists 17 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 23, 2012. 4 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Synergetics, Inc.
FDA registration number
1932402
FEI number
1000119053
Address
3845 Corporate Centre Dr, O Fallon, MO, United States, 63368
Owner or operator
SYNERGETICS, INC. (9005675)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
First device listed
June 12, 1992
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Cautery, Radiofrequency, Ac-PoweredHQR2Manufactureraccessdata.fda.gov
Cannula, OphthalmicHMX1Manufactureraccessdata.fda.gov
Cannula, Trocar, OphthalmicNGY1Manufacturer, Specification developeraccessdata.fda.gov
Clip, Iris RetractorHOC1Manufactureraccessdata.fda.gov
EndoilluminatorMPA2Manufactureraccessdata.fda.gov
Forceps, OphthalmicHNR1Complaint file establishment, Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufacturer, Specification developeraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Contract manufacturer, Manufactureraccessdata.fda.gov
Instrument, Vitreous Aspiration And Cutting, Ac-PoweredHQE2Manufactureraccessdata.fda.gov
Knife, OphthalmicHNN1Manufactureraccessdata.fda.gov
Magnet, PermanentHPN1Manufactureraccessdata.fda.gov
Photocoagulator And AccessoriesHQB2Manufactureraccessdata.fda.gov
Pump, Infusion, OphthalmicMRH2Specification developeraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufactureraccessdata.fda.gov
Scissors, OphthalmicHNF1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Unit, PhacofragmentationHQC2Contract manufactureraccessdata.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
April 23, 2012K113857SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBEHQBSubstantially EquivalentSynergetics, Inc.accessdata.fda.gov
January 7, 2000K993039VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)MRHSubstantially EquivalentBausch & Lomb, Inc.accessdata.fda.gov
January 5, 1996K952585GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATORMPASubstantially EquivalentGamp & Assoc.accessdata.fda.gov
January 5, 1996K952569GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATORHQRSubstantially EquivalentGamp & Assoc.accessdata.fda.gov
December 22, 1995K954308GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBEHQBSubstantially EquivalentGamp & Assoc.accessdata.fda.gov
December 22, 1995K954307GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBEHQBSubstantially EquivalentGamp & Assoc.accessdata.fda.gov
December 22, 1995K954306GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBEHQBSubstantially EquivalentGamp & Assoc.accessdata.fda.gov
September 1, 1995K952586GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATORMPASubstantially EquivalentGamp & Assoc.accessdata.fda.gov
September 1, 1995K952584GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICKMPASubstantially EquivalentGamp & Assoc.accessdata.fda.gov
February 23, 1994K932668OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVERHQESubstantially EquivalentSynergetics, Inc.accessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
June 12, 202494793Class IOngoingBAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)Sterilization certificates could not be validated by the supplieraccessdata.fda.gov
August 11, 201674918Class IITerminated25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.accessdata.fda.gov
December 9, 201367147Class IITerminatedStandard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.accessdata.fda.gov
July 30, 201365969Class IITerminatedSynergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.accessdata.fda.gov

Compare with other makers

Updated July 11, 2024. 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.