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Synergetics, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 3845 Corporate Centre Dr, O Fallon, MO, 63368
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000119053
DUNS Number: —

Catalogue (580)

Page 12 of 12

Device	Model / Reference	Registries	Class	Status
Synergetics	39.32.25PIN	FDA UDI	Class I	Active
Synergetics	55.26.25L	FDA UDI	Class II	Active
Synergetics	11.20S	FDA UDI	Class I	Active
Synergetics	70025SP	FDA UDI	Class II	Active
Synergetics	56.02.25PS	FDA UDI	Class II	Active
Synergetics	29.22.23	FDA UDI	Class I	Active
Synergetics	BL5820M	FDA UDI	Class II	Active
Synergetics	30.08	FDA UDI	Class I	Active
Synergetics	34.01A	FDA UDI	Class I	Active
Synergetics	OFSP-03162017	FDA UDI	Class I	Active
Synergetics	55.27.25	FDA UDI	Class II	Active
Synergetics	18061	FDA UDI	Class I	Unknown
Stryker Rf Multi-Lesion Generator, Model 0406-900-000	K071482	FDA 510(k)	Class II	Active
Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps	K110924	FDA 510(k)	Class II	Active
Synergetics Synerlight Fiber Optic Lightsource	K964005	FDA 510(k)	Class II	Active
Scrambled Endooto Laser Probe, Straight Tip, Model 59.02, Scrambled Endooto Laser Probe Bent Tip, Model 59.01	K990568	FDA 510(k)	Class II	Active
Stryker Intradiscal Rf Generator	K063489	FDA 510(k)	Class II	Active
Ophthalmic Surgical Pneumatic Scissors Driver	K932668	FDA 510(k)	Class II	Active
Ophthalmic Pharco Needle	K923725	FDA 510(k)	Class II	Active
Spetzler Malis Dual Illuminating Bipolar Forceps	K160103	FDA 510(k)	Class II	Active
Sonotome Ultrasonic Aspirator Tips	K010637	FDA 510(k)	U	Active
Ultrasonic Straight/Ultrasonic Knife/Ultrasonic Ring Currette	K020220	FDA 510(k)	U	Active
Synergetics PHOTON EX	K143123	FDA 510(k)	Class II	Active
Synergetics Adjustable Gas Pressurized Infusion (agpi) Tube Set	K091441	FDA 510(k)	Class II	Active
Synergetics Synerlight Fiber Optic Lightsource	K032598	FDA 510(k)	Class II	Active
Veritas Bipolar, Insulated, 0.5mm Tip, Model N301-005 Veritas Bipolar, Insulated 1.0mm Tip Model N301-010	K982212	FDA 510(k)	Class II	Active
Versavit	K121675	FDA 510(k)	Class II	Active
Synergetics Directional Endoocular Laser Probe	K113857	FDA 510(k)	Class II	Active
Ophthalmic Viscoinjector Drive	K923326	FDA 510(k)	Class II	Active
Aynergetics Disposable Spetzler-Malis Standard Bipolar Forceps	K121426	FDA 510(k)	Class II	Active

Related Companies

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Importers

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Notified Bodies

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FDA Recalls (37)

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
Jun 12, 2024	Z-2253-2024	—	open, classified	Sterilization certificates could not be validated by the supplier
Jun 12, 2024	Z-2254-2024	—	open, classified	Sterilization certificates could not be validated by the supplier
Jun 12, 2024	Z-2252-2024	—	open, classified	Sterilization certificates could not be validated by the supplier
Jun 12, 2024	Z-2251-2024	—	open, classified	Sterilization certificates could not be validated by the supplier
Aug 11, 2016	Z-0120-2017	—	terminated	Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Aug 11, 2016	Z-0122-2017	—	terminated	Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Aug 11, 2016	Z-0121-2017	—	terminated	Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Aug 11, 2016	Z-0119-2017	—	terminated	Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Dec 9, 2013	Z-0899-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0883-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0892-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0876-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0877-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0895-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0872-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0875-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0873-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0882-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0896-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0885-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0894-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0880-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0881-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0891-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0886-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0874-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0897-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0898-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0878-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0889-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0888-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0884-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0887-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0890-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0879-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Dec 9, 2013	Z-0893-2014	—	terminated	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Jul 30, 2013	Z-0051-2014	—	terminated	One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.