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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 3 of 12
DeviceModel / ReferenceRegistriesClassStatus
Synergetics 23.02A
FDA UDI
Class IActive
Synergetics 11.06.25PIN
FDA UDI
Class IActive
Synergetics BL5820D
FDA UDI
Class IIUnknown
Synergetics 55.36.23ETX
FDA UDI
Class IIActive
Synergetics 55.26.25
FDA UDI
Class IIActive
Synergetics 30.08.27
FDA UDI
Class IActive
Synergetics 55.12
FDA UDI
Class IIActive
Synergetics 34.22
FDA UDI
Class IActive
Synergetics 09.10.23
FDA UDI
Class IActive
Synergetics 39.15.23PIN-M
FDA UDI
Class IActive
Synergetics D30.10
FDA UDI
Class IActive
Synergetics 55.21.23
FDA UDI
Class IIActive
Synergetics 56.55.27P
FDA UDI
Class IIActive
Synergetics 58.23SV
FDA UDI
Class IActive
Synergetics 56.12.27P
FDA UDI
Class IIActive
Synergetics 20025E
FDA UDI
Class IIActive
Synergetics BL5820D
FDA UDI
Class IIActive
Synergetics 10.21S
FDA UDI
Class IActive
Synergetics 23.09A
FDA UDI
Class IActive
Synergetics D29.02
FDA UDI
Class IActive
Synergetics 23.56.23S
FDA UDI
Class IActive
Codman 80-1277
FDA UDI
Class IIActive
Synergetics 70933
FDA UDI
Class IIActive
Codman 80-7607
FDA UDI
Class IIActive
Synergetics 31.02
FDA UDI
Class IActive
Synergetics 10.23S
FDA UDI
Class IActive
Synergetics 39.08.23PIN
FDA UDI
Class IActive
Synergetics 56.12.25P
FDA UDI
Class IIActive
Synergetics 20025S
FDA UDI
Class IIActive
Synergetics 70025SID
FDA UDI
Class IIActive
Synergetics 23.21
FDA UDI
Class IActive
Codman 80-7601
FDA UDI
Class IIActive
Synergetics 40.01-6
FDA UDI
Class IActive
Synergetics 19030
FDA UDI
Class IActive
Synergetics 58.20-6
FDA UDI
Class IActive
Synergetics 58.25STH
FDA UDI
Class IActive
Codman 80-7615
FDA UDI
Class IIActive
Synergetics 09.10.25PIN-M
FDA UDI
Class IActive
Photon P2-PHOTON-1X
FDA UDI
Class IIActive
Synergetics 10.23
FDA UDI
Class IActive
Synergetics 52.20
FDA UDI
Class IActive
Synergetics 56.30P
FDA UDI
Class IIActive
Synergetics 39.28
FDA UDI
Class IActive
Synergetics D39.10.25
FDA UDI
Class IActive
Synergetics 56.20.23P
FDA UDI
Class IIActive
Synergetics 17680
FDA UDI
Class IActive
Synergetics 55.26.25S
FDA UDI
Class IIActive
Synergetics 10.24S
FDA UDI
Class IActive
Synergetics 10.24
FDA UDI
Class IActive
Synergetics 58.25S
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.