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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 8 of 12
DeviceModel / ReferenceRegistriesClassStatus
Synergetics 13.01
FDA UDI
Class IActive
Synergetics 09.50
FDA UDI
Class IActive
Synergetics VFIHP
FDA UDI
Class IActive
Synergetics 70027E
FDA UDI
Class IIActive
Synergetics 55.26.25E
FDA UDI
Class IIActive
Synergetics 39.12.25PIN
FDA UDI
Class IActive
Synergetics 55.26.27
FDA UDI
Class IIActive
Codman 80-7612
FDA UDI
Class IIActive
Synergetics 34.02A
FDA UDI
Class IActive
Synergetics 28.30.23
FDA UDI
Class IActive
Synergetics BL7623
FDA UDI
Class IActive
Synergetics DSYN-LB90-05I
FDA UDI
Class IIActive
Synergetics 09.10.23S
FDA UDI
Class IActive
Synergetics 20.22
FDA UDI
Class IActive
Synergetics 70023SID
FDA UDI
Class IIActive
Synergetics 12.03
FDA UDI
Class IActive
Synergetics D39.03.25
FDA UDI
Class IActive
Synergetics 70023SP
FDA UDI
Class IIActive
Synergetics 64.22
FDA UDI
Class IActive
Synergetics 10.05A
FDA UDI
Class IActive
Synergetics 31.01
FDA UDI
Class IActive
Codman 80-7600
FDA UDI
Class IIActive
Synergetics 12.21
FDA UDI
Class IActive
Synergetics 29.22
FDA UDI
Class IActive
Synergetics 21.21
FDA UDI
Class IActive
Synergetics 11.04PIN
FDA UDI
Class IActive
Synergetics 30.08.25
FDA UDI
Class IActive
Synergetics 28.22
FDA UDI
Class IActive
Synergetics 23.56.25S
FDA UDI
Class IActive
Codman 80-1271
FDA UDI
Class IIActive
Synergetics 20.04
FDA UDI
Class IActive
Synergetics 28.06
FDA UDI
Class IActive
Synergetics D09.04
FDA UDI
Class IActive
Synergetics D39.08.25
FDA UDI
Class IActive
Synergetics 02.03
FDA UDI
Class IActive
Synergetics 30.01
FDA UDI
Class IActive
Synergetics 11.26
FDA UDI
Class IActive
Synergetics 70023E
FDA UDI
Class IIActive
Synergetics 55.26.23TX
FDA UDI
Class IIActive
Synergetics BL5237S
FDA UDI
Class IIActive
Synergetics D39.08
FDA UDI
Class IActive
Synergetics 10.24PIN
FDA UDI
Class IActive
Synergetics 56.61P
FDA UDI
Class IIActive
Synergetics 70025S
FDA UDI
Class IIActive
Synergetics 20.04.23
FDA UDI
Class IActive
Synergetics 55.47P
FDA UDI
Class IIActive
Synergetics 20027S
FDA UDI
Class IIActive
Synergetics 39.23.23S
FDA UDI
Class IActive
Synergetics 55.48.23P
FDA UDI
Class IIActive
Synergetics 55.36E
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.