Company
Beaver Visitec
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2019 | Beaver Visitec Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel,
Ophthalmic-utilized in Cataract and Glaucoma procedures
REF # 370824
Product Usage:
Ophthalmic techniques-utilized in Cataract and Glaucoma proc Terminated |
HNN | None listed |
| Feb 19, 2019 | Beaver Visitec Micro Knife 5.0mm 30, Part Number 0001522
The Beaver Micro Knife 5.0mm 30 is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techn Terminated |
HNN | None listed |
| Nov 30, 2018 | Beaver Visitec BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in).
The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove mater Terminated |
HMX | None listed |
| Jul 19, 2018 | Beaver Visitec Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000
Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arre Terminated |
HQP | K771189 |
| Jun 18, 2018 | Beaver Visitec Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery. Terminated |
HNN | None listed |
| May 14, 2018 | Beaver Visitec Safety Sideport Knife 1.0mm 45, REF 378210
Product Usage:
Indicated to make stab incisions during ophthalmic surgery Terminated |
EMF | None listed |