Beaver-Visitec International, Inc.
United States Last updated 25 Oct 2026
- Devices
- 1,809
- Registries
- EUDAMEDGUDIDFDA PMAFDA
- FDA recalls
- 195181 ongoing
Catalogue
Ophthalmic Blade Handles, Collets & Wrenches Ref 371415
Ophthalmic Blade Handles, Collets & Wrenches Ref 374311
Ophthalmic Blade Handles, Collets & Wrenches Ref 374340
Ophthalmic Blade Handles, Collets & Wrenches Ref 371301
Ophthalmic Blade Handles, Collets & Wrenches Ref 374312
Ophthalmic Blade Handles, Collets & Wrenches Ref 375000
Ophthalmic Blade Handles, Collets & Wrenches Ref 371360
Ophthalmic Blade Handles, Collets & Wrenches Ref 374330
FINEVISION HP Trifocal IOLs Ref P240038
Showing 1,801-1,809 of 1,809
EUDAMED certificates
TÜV SÜD Product Service GmbH 0123 1 certificate
- G15 103871 0011 Supplemented
Quality management system EU MDR
- Issued
- 19 Mar 2026
- Expires
- 9 Nov 2030
- Reason
- Add device or group
Related companies
Authorised representatives
- Bvi Eu B.V. NL
Notified bodies
FDA recalls
2025
- 5 Dec 2025 Z-1008-2026 Class II Ongoing Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).
2024
- 26 Jul 2024 Z-2781-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2782-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2783-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2784-2024 Class II Ongoing Data in RES.
- 26 Jul 2024 Z-2785-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2786-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2787-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2788-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2789-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
Show the 25 most recent of 195 recalls
2024
- 26 Jul 2024 Z-2790-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2791-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2792-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2793-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2794-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2795-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2796-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2797-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2798-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2799-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2800-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2801-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2802-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2803-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
- 26 Jul 2024 Z-2804-2024 Class II Ongoing Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
FDA establishments
- Beaver-Visitec International, Inc. Ciudad Juarez Chihuahua · MX FEI 3013421458
- Beaver-Visitec International, Ltd BIDFORD-ON-AVON Warwickshire · GB FEI 3002808441
What Beaver-Visitec International, Inc. makes
The company manufactures single-use ophthalmic surgical tools and accessories, including non-medicated procedure kits, irrigation/infusion/aspiration cannulas, soft-tissue manipulation forceps, ocular hooks, spatulas, lacrimal punctum plugs, and surgical drapes. It also produces human-derived ENT space-occupying dressings and custom ophthalmic sponges for surgical use.
These devices are classified under FDA’s Class I and Class II categories, with some falling under the exempt (U) classification. They are listed in the FDA’s Unique Device Identifier (UDI) database, adhering to U.S. regulatory requirements.
Frequently asked questions
How many devices does Beaver-Visitec International, Inc. have in the registry?
The registry currently lists 1809 devices for Beaver-Visitec International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Are there FDA recall records for Beaver-Visitec International, Inc.?
FDA recall records list 195 recalls initiated by Beaver-Visitec International, Inc., the most recent initiated on 2025-12-05. 181 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Beaver-Visitec International, Inc.?
EUDAMED lists 1 certificate for Beaver-Visitec International, Inc. (quality management system) under MDR. The most recent was issued on 2026-03-19.
Which FDA establishments are linked to Beaver-Visitec International, Inc.?
2 FDA establishments are linked to Beaver-Visitec International, Inc. in the registry; they are listed on the company page.
Information
- Address
- 6447 Parkland Drive, Sarasota, United States
- Website
- BVIMedical.com
- [email protected]
- PRRC contact
- Chris Brady
- EUDAMED SRN
- US-MF-000011461
- FDA FEI number
- 1211998