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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 1 of 12
DeviceModel / ReferenceRegistriesClassStatus
Synergetics 12.01
FDA UDI
Class IActive
Synergetics 20.51
FDA UDI
Class IActive
Photon PSPA-P2
FDA UDI
Class IIActive
Synergetics 39.27.23
FDA UDI
Class IActive
Synergetics 09.25.25
FDA UDI
Class IActive
Synergetics 12.13
FDA UDI
Class IActive
Synergetics 09.11.23PIN
FDA UDI
Class IActive
Synergetics P2-PLAMP
FDA UDI
Class IIActive
Synergetics 23.29.23
FDA UDI
Class IActive
Synergetics 30.22
FDA UDI
Class IActive
Synergetics 55.21.27
FDA UDI
Class IIActive
Synergetics 55.23.23
FDA UDI
Class IIActive
Synergetics D00.01SL
FDA UDI
Class IActive
Synergetics D23.76.23
FDA UDI
Class IActive
Synergetics 56.34.25P
FDA UDI
Class IIActive
Synergetics 55.70.23P
FDA UDI
Class IIActive
Synergetics 52.00
FDA UDI
Class IActive
Synergetics 11.28S
FDA UDI
Class IActive
Synergetics OFSP-01202017
FDA UDI
Class IActive
Synergetics 11.23
FDA UDI
Class IActive
Synergetics 56.00.25P
FDA UDI
Class IIActive
Synergetics 10.25S
FDA UDI
Class IActive
Synergetics D31.08.23
FDA UDI
Class IActive
Synergetics 11.20PIN
FDA UDI
Class IActive
Codman 80-7605
FDA UDI
Class IIActive
Synergetics 39.23.25S
FDA UDI
Class IActive
Synergetics BL5825M
FDA UDI
Class IIActive
Synergetics 56.21.23
FDA UDI
Class IIActive
Synergetics BL7610
FDA UDI
Class IActive
Synergetics 56.51.25P
FDA UDI
Class IIActive
Synergetics 55.26.23E
FDA UDI
Class IIActive
Synergetics 09.25.23
FDA UDI
Class IActive
Synergetics 23.07A
FDA UDI
Class IActive
Synergetics 56.55.23P
FDA UDI
Class IIActive
Synergetics 70020S
FDA UDI
Class IIActive
Synergetics 28.30
FDA UDI
Class IActive
Synergetics 58.23STH
FDA UDI
Class IActive
Synergetics 23.28
FDA UDI
Class IActive
Synergetics 56.53.23P
FDA UDI
Class IIActive
Synergetics 70025E
FDA UDI
Class IIActive
Synergetics 28.07
FDA UDI
Class IActive
Synergetics 56.12.23P
FDA UDI
Class IIActive
Synergetics 20.02.23
FDA UDI
Class IActive
Synergetics 23.03A
FDA UDI
Class IActive
Synergetics 11.06PIN
FDA UDI
Class IActive
Synergetics 20.31
FDA UDI
Class IActive
Synergetics 56.52.25P
FDA UDI
Class IIActive
Synergetics 23.26
FDA UDI
Class IActive
Synergetics 30.35
FDA UDI
Class IActive
Synergetics 09.08.23A
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.