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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 5 of 12
DeviceModel / ReferenceRegistriesClassStatus
Synergetics 39.15.27PIN
FDA UDI
Class IActive
Synergetics 57.41
FDA UDI
Class IIActive
Synergetics 23.76PIN
FDA UDI
Class IActive
Synergetics 58.25
FDA UDI
Class IActive
Synergetics 40.02-2
FDA UDI
Class IActive
Synergetics 09.05.23A
FDA UDI
Class IActive
Synergetics BL7625
FDA UDI
Class IActive
Synergetics 40.02-6
FDA UDI
Class IActive
Synergetics 18069W
FDA UDI
Class IUnknown
Synergetics 09.10.25PIN
FDA UDI
Class IActive
Synergetics 11.04.25PIN
FDA UDI
Class IActive
Synergetics 70937
FDA UDI
Class IIActive
Synergetics 65967
FDA UDI
Class IIActive
Synergetics BL5823M
FDA UDI
Class IIActive
Synergetics 55.62.25P
FDA UDI
Class IIActive
Synergetics 56.02P
FDA UDI
Class IIActive
Synergetics 65025E
FDA UDI
Class IIActive
Synergetics 23.56
FDA UDI
Class IActive
Synergetics 58.27SV
FDA UDI
Class IActive
Synergetics 39.21S
FDA UDI
Class IActive
Synergetics 20.04.27
FDA UDI
Class IActive
Synergetics 23.56.23
FDA UDI
Class IActive
Synergetics 20.01
FDA UDI
Class IActive
Synergetics 17580
FDA UDI
Class IActive
Synergetics 55.36.25E
FDA UDI
Class IIActive
Synergetics 55.69.23P
FDA UDI
Class IIActive
Synergetics 57.40
FDA UDI
Class IIActive
Synergetics 30.08.23
FDA UDI
Class IActive
Synergetics 56.24.23P
FDA UDI
Class IIActive
Synergetics DSYN-LB80-15I
FDA UDI
Class IIActive
Synergetics 20.41.25
FDA UDI
Class IActive
Synergetics 23.22S
FDA UDI
Class IActive
Synergetics 09.08A
FDA UDI
Class IActive
Synergetics 56.65
FDA UDI
Class IIActive
Synergetics 55.21
FDA UDI
Class IIActive
Synergetics 55.25.25TX
FDA UDI
Class IIActive
Synergetics 21.01APXM
FDA UDI
Class IActive
Synergetics 34.72
FDA UDI
Class IActive
Synergetics 11.41.23
FDA UDI
Class IActive
Synergetics 11.27
FDA UDI
Class IActive
Synergetics D23.76.25
FDA UDI
Class IActive
Synergetics 39.07.25PIN
FDA UDI
Class IActive
Synergetics 55.26.231
FDA UDI
Class IIActive
Synergetics 55.69P
FDA UDI
Class IIActive
Synergetics 58.20
FDA UDI
Class IActive
Synergetics 24.01A
FDA UDI
Class IActive
Photon PSPA-A
FDA UDI
Class IIActive
Synergetics 56.54.25P
FDA UDI
Class IIActive
Synergetics D31.08.25
FDA UDI
Class IActive
Synergetics 56.02.25
FDA UDI
Class IIActive

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.