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Beaver-Visitec International, Inc.

United States US-MF-000011461 Last updated 23 Oct 2026

Devices
1,785
Registries
EUDAMEDFDA
FDA recalls
195181 ongoing

Catalogue1,785

Page 1 of 36

Showing 1-50 of 1,785

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

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

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Notified bodies

FDA recalls195

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Showing the 10 most recent of 195 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).via FDA establishment Beaver-Visitec International, Inc.

  • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 26 Jul 2024 Z-2784-2024 Class II Ongoing Data in RES.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.
    • 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.via FDA establishment Beaver-Visitec International, Inc.

FDA establishments2

Registered with the FDA under this company group, matched by name.

  • 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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Beaver-Visitec International, Inc. manufacture?

Beaver-Visitec International, Inc. specializes in single-use ophthalmic surgical tools and accessories. These include non-medicated surgical procedure kits, irrigation/infusion/aspiration cannulas, soft-tissue manipulation forceps, ocular hooks, spatulas, lacrimal punctum plugs, surgical drapes, and custom ophthalmic sponges. The company also produces human-derived ENT space-occupying dressings for surgical applications. All devices are designed for one-time use to minimize infection risks.

Where is Beaver-Visitec International, Inc. based?

Beaver-Visitec International, Inc. is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards, including those governing medical device manufacturing and distribution.

Which regulatory registries list Beaver-Visitec International, Inc.’s devices?

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical for tracking and transparency in the U.S. healthcare system, ensuring traceability of medical devices from manufacturing to patient use. Listing in the UDI database is required for compliance with FDA regulations.

How are Beaver-Visitec International, Inc.’s devices classified under FDA regulations?

Beaver-Visitec International, Inc.’s devices fall under FDA’s Class I and Class II categories, with some classified as exempt (U). Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls. The exempt (U) classification means these devices are subject to fewer regulatory requirements, typically due to minimal risk or existing regulatory oversight. Classification depends on factors like device purpose, intended use, and potential patient risk.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
6447 Parkland Drive, Sarasota, United States
PRRC contact
Chris Brady
EUDAMED SRN
US-MF-000011461
FDA FEI number
1211998