Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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 7 of 12
DeviceModel / ReferenceRegistriesClassStatus
Synergetics 10.24.25S
FDA UDI
Class IActive
Synergetics 55.21.25S
FDA UDI
Class IIActive
Synergetics 39.08.27PIN
FDA UDI
Class IActive
Synergetics 65035E
FDA UDI
Class IIActive
Synergetics 54.06
FDA UDI
Class IIActive
Photon P2-PHOTON-2X
FDA UDI
Class IIActive
Codman 80-1270
FDA UDI
Class IIActive
Synergetics 11.28.23
FDA UDI
Class IActive
Synergetics 09.10.25A
FDA UDI
Class IActive
Synergetics 56.21.23P
FDA UDI
Class IIActive
Synergetics 39.07.23PIN
FDA UDI
Class IActive
Synergetics 70123B
FDA UDI
Class IIActive
Synergetics 58.23
FDA UDI
Class IActive
Synergetics 16579
FDA UDI
Class IActive
Synergetics 09.07.25A
FDA UDI
Class IActive
Synergetics 09.50.25
FDA UDI
Class IActive
Synergetics 15.01
FDA UDI
Class IActive
Synergetics 65963
FDA UDI
Class IIActive
Synergetics 56.50.25P
FDA UDI
Class IIActive
Synergetics 11.40S
FDA UDI
Class IActive
Synergetics 20.02
FDA UDI
Class IActive
Synergetics 55.27.27
FDA UDI
Class IIActive
Synergetics 20.02.25
FDA UDI
Class IActive
Synergetics BL5241
FDA UDI
Class IActive
Synergetics 09.03.23A
FDA UDI
Class IActive
Synergetics 55.26.251
FDA UDI
Class IIActive
Synergetics D31.08
FDA UDI
Class IActive
Synergetics 23.76.25PIN
FDA UDI
Class IActive
Synergetics BL5823F
FDA UDI
Class IIActive
Synergetics 56.45.23P
FDA UDI
Class IIActive
Synergetics 09.11.25PIN
FDA UDI
Class IActive
Synergetics 10.25
FDA UDI
Class IActive
Synergetics 09.05A
FDA UDI
Class IActive
Synergetics 10.24.23PIN
FDA UDI
Class IActive
Synergetics 56.54.27P
FDA UDI
Class IIActive
Synergetics 55.62.23P
FDA UDI
Class IIActive
Synergetics 40.01-2
FDA UDI
Class IActive
Synergetics 20.03
FDA UDI
Class IActive
Synergetics 39.27.25
FDA UDI
Class IActive
Synergetics 10.04A
FDA UDI
Class IActive
Synergetics 09.25.25S
FDA UDI
Class IActive
Codman 80-7610
FDA UDI
Class IIActive
Synergetics D31.06
FDA UDI
Class IActive
Synergetics 65020E
FDA UDI
Class IIActive
Synergetics 30.32.25
FDA UDI
Class IActive
Synergetics 23.23S
FDA UDI
Class IActive
Synergetics 41.00
FDA UDI
Class IActive
Synergetics 70935
FDA UDI
Class IIActive
Synergetics BL5625S
FDA UDI
Class IIActive
Synergetics 56.21.25PS
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.