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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
—
EUDAMED SRN
—
FDA FEI Number
1000119053
DUNS Number
—

Catalogue (580)

Page 9 of 12
DeviceModel / ReferenceRegistriesClassStatus
Synergetics 64.22S
FDA UDI
Class IActive
Synergetics 34.71
FDA UDI
Class IActive
Synergetics 34.74
FDA UDI
Class IActive
Synergetics 12.40
FDA UDI
Class IActive
Synergetics 65023E
FDA UDI
Class IIActive
Synergetics 10.24.23S
FDA UDI
Class IActive
Synergetics 39.32.23PIN
FDA UDI
Class IActive
Synergetics 70027SP
FDA UDI
Class IIActive
Synergetics 10.21
FDA UDI
Class IActive
Synergetics 55.70.25P
FDA UDI
Class IIActive
Synergetics 39.28.23S
FDA UDI
Class IActive
Synergetics 23.56.25
FDA UDI
Class IActive
Synergetics BL5235S
FDA UDI
Class IIActive
Synergetics D39.15.23
FDA UDI
Class IActive
Synergetics 23.26S
FDA UDI
Class IActive
Synergetics 58.23S
FDA UDI
Class IActive
Synergetics 65033E
FDA UDI
Class IIActive
Codman 80-7613
FDA UDI
Class IIActive
Codman 80-7603
FDA UDI
Class IIActive
Synergetics 55.26.25TX
FDA UDI
Class IIActive
Synergetics 23.26.23S
FDA UDI
Class IActive
Synergetics 55.22
FDA UDI
Class IIActive
Synergetics 56.02.23P
FDA UDI
Class IIActive
Synergetics 56.22.23P
FDA UDI
Class IIActive
Synergetics 12.21S
FDA UDI
Class IActive
Synergetics BL5820M
FDA UDI
Class IIUnknown
Synergetics 56.21P
FDA UDI
Class IIActive
Synergetics 30.02
FDA UDI
Class IActive
Synergetics 11.22
FDA UDI
Class IActive
Codman 80-1273
FDA UDI
Class IIActive
Synergetics 23.01A
FDA UDI
Class IActive
Synergetics 55.47.25P
FDA UDI
Class IIActive
Synergetics 56.07
FDA UDI
Class IIActive
Synergetics DSYN-LB90-10I
FDA UDI
Class IIActive
Synergetics 34.70
FDA UDI
Class IActive
Synergetics 30.21
FDA UDI
Class IActive
Synergetics 56.01
FDA UDI
Class IIActive
Synergetics 39.23.23
FDA UDI
Class IActive
Synergetics 23.26.23
FDA UDI
Class IActive
Synergetics 10.03A
FDA UDI
Class IActive
Synergetics 09.12PIN
FDA UDI
Class IActive
Synergetics 18069
FDA UDI
Class IUnknown
Synergetics 09.12.25PIN
FDA UDI
Class IActive
Synergetics 10.04.25A
FDA UDI
Class IActive
Synergetics 09.04PIN
FDA UDI
Class IActive
Synergetics 58.2023-3MM
FDA UDI
Class IActive
Synergetics 56.20.25P
FDA UDI
Class IIActive
Synergetics 30.90
FDA UDI
Class IActive
Synergetics 23.06A
FDA UDI
Class IActive
Synergetics 09.03.25A
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.