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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 4 of 12
DeviceModel / ReferenceRegistriesClassStatus
Synergetics 18067
FDA UDI
Class IActive
Synergetics 20023E
FDA UDI
Class IIActive
Synergetics 09.50.25A
FDA UDI
Class IActive
Synergetics 09.10.25
FDA UDI
Class IActive
Codman 80-1276
FDA UDI
Class IIActive
Agpi 17565-10
FDA UDI
Class IIUnknown
Synergetics 55.36.25ETX
FDA UDI
Class IIActive
Synergetics 34.80
FDA UDI
Class IActive
Synergetics 56.02.23
FDA UDI
Class IIActive
Synergetics D00.01SS
FDA UDI
Class IActive
Synergetics 09.10.25S
FDA UDI
Class IActive
Codman 80-7608
FDA UDI
Class IIActive
Synergetics 34.21S
FDA UDI
Class IActive
Synergetics 20.16
FDA UDI
Class IActive
Synergetics 65965
FDA UDI
Class IIActive
Synergetics 21.01HPXM
FDA UDI
Class IActive
Synergetics D39.03.23
FDA UDI
Class IActive
Synergetics 57.20
FDA UDI
Class IIActive
Synergetics D39.08.23
FDA UDI
Class IActive
Synergetics 30.07
FDA UDI
Class IActive
Synergetics 11.28
FDA UDI
Class IActive
Synergetics 09.50A
FDA UDI
Class IActive
Synergetics 29.05A
FDA UDI
Class IActive
Synergetics 39.21
FDA UDI
Class IActive
Synergetics 30.06
FDA UDI
Class IActive
Synergetics 58.23STHV
FDA UDI
Class IActive
Synergetics 56.65.27
FDA UDI
Class IIActive
Synergetics 56.12
FDA UDI
Class IIActive
Synergetics 09.04A
FDA UDI
Class IActive
Synergetics 23.76.23PIN
FDA UDI
Class IActive
Synergetics 30.18.25
FDA UDI
Class IActive
Synergetics 11.23.23
FDA UDI
Class IActive
Synergetics 12.02
FDA UDI
Class IActive
Synergetics 11.24S
FDA UDI
Class IActive
Synergetics 39.03.27PIN
FDA UDI
Class IActive
Synergetics 30.11.23
FDA UDI
Class IActive
Synergetics 30.10
FDA UDI
Class IActive
Synergetics 18060
FDA UDI
Class IUnknown
Synergetics 58.27S
FDA UDI
Class IActive
Synergetics VFIMOD
FDA UDI
Class IActive
Synergetics 55.27.23
FDA UDI
Class IIActive
Synergetics BL5825D
FDA UDI
Class IIActive
Synergetics 34.75
FDA UDI
Class IActive
Synergetics 23.22
FDA UDI
Class IActive
Synergetics 30.10.23
FDA UDI
Class IActive
Synergetics 09.25S
FDA UDI
Class IActive
Synergetics 70020SP
FDA UDI
Class IIActive
Synergetics 11.40
FDA UDI
Class IActive
Synergetics 20.41
FDA UDI
Class IActive
Synergetics 09.10.23PIN
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.