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Synergetics, Inc.

US

Last updated September 17, 2026

Information

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

Catalogue (580)

Page 2 of 12
DeviceModel / ReferenceRegistriesClassStatus
Synergetics 20.07
FDA UDI
Class IActive
Synergetics 70023S
FDA UDI
Class IIActive
Synergetics 11.23S
FDA UDI
Class IActive
Synergetics 23.21S
FDA UDI
Class IActive
Synergetics 56.21
FDA UDI
Class IIActive
Synergetics 53.00.25
FDA UDI
Class IIActive
Synergetics 23.29
FDA UDI
Class IActive
Synergetics 55.25.25
FDA UDI
Class IIActive
Synergetics BL7600
FDA UDI
Class IIActive
Synergetics 56.22.27P
FDA UDI
Class IIActive
Synergetics DSYN-LB80-05I
FDA UDI
Class IIActive
Synergetics D39.15.25
FDA UDI
Class IActive
Synergetics 11.20
FDA UDI
Class IActive
Synergetics SE5625
FDA UDI
Class IIActive
Synergetics 09.01A
FDA UDI
Class IActive
Synergetics 55.47.23P
FDA UDI
Class IIActive
Synergetics 11.03.23A
FDA UDI
Class IActive
Synergetics 39.15.25PIN
FDA UDI
Class IActive
Synergetics 20020E
FDA UDI
Class IIActive
Synergetics 55.26
FDA UDI
Class IIActive
Synergetics 39.28S
FDA UDI
Class IActive
Codman 80-7604
FDA UDI
Class IIActive
Synergetics D23.76
FDA UDI
Class IActive
Synergetics SE5623
FDA UDI
Class IIActive
Synergetics 55.26TX
FDA UDI
Class IIActive
Synergetics 11.40PIN
FDA UDI
Class IActive
Synergetics 10.04.23A
FDA UDI
Class IActive
Synergetics DSYN-LB80-10I
FDA UDI
Class IIActive
Synergetics 11.02A
FDA UDI
Class IActive
Synergetics D28.30.23
FDA UDI
Class IActive
Synergetics 56.65.23
FDA UDI
Class IIActive
Synergetics 55.63P
FDA UDI
Class IIActive
Synergetics 30.09
FDA UDI
Class IActive
Synergetics BL7620
FDA UDI
Class IActive
Synergetics 18063
FDA UDI
Class IUnknown
Synergetics 39.28.23
FDA UDI
Class IActive
Synergetics 20.04.25S
FDA UDI
Class IActive
Synergetics 65960
FDA UDI
Class IIActive
Photon PSPA
FDA UDI
Class IIActive
Synergetics 56.07.23P
FDA UDI
Class IIActive
Synergetics 11.26S
FDA UDI
Class IActive
Synergetics 34.76
FDA UDI
Class IActive
Synergetics 11.08A
FDA UDI
Class IActive
Synergetics 17570
FDA UDI
Class IActive
Synergetics 12.03.25
FDA UDI
Class IActive
Synergetics 55.29
FDA UDI
Class IIActive
Synergetics 58.23-3MMV
FDA UDI
Class IActive
Synergetics BL5827D
FDA UDI
Class IIActive
Synergetics D31.01
FDA UDI
Class IActive
Synergetics 39.23
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Jun 12, 2024Z-2253-2024—open, classified

Sterilization certificates could not be validated by the supplier

Jun 12, 2024Z-2254-2024—open, classified

Sterilization certificates could not be validated by the supplier

Jun 12, 2024Z-2252-2024—open, classified

Sterilization certificates could not be validated by the supplier

Jun 12, 2024Z-2251-2024—open, classified

Sterilization certificates could not be validated by the supplier

Aug 11, 2016Z-0120-2017—terminated

Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.

Aug 11, 2016Z-0122-2017—terminated

Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.

Aug 11, 2016Z-0121-2017—terminated

Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.

Aug 11, 2016Z-0119-2017—terminated

Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.

Dec 9, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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, 2013Z-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.