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Boss Instruments, Ltd.

US

Last updated September 17, 2026

About

BOSS provides the highest quality, German-made surgical instruments and retractor systems, backed by our lifetime guarantee and 30-day easy return policy.

From the manufacturer's own website. Source

What Boss Instruments, Ltd. makes

Boss Instruments, Ltd. manufactures reusable surgical instruments, including spinal rongeurs, hand-held retractors, retraction system blades, scissors-like and tweezers-like forceps, general-purpose surgical scissors, needle holders, and bulldog clamps. These tools are designed for soft-tissue manipulation, retraction, and suturing in surgical procedures.

The company’s products are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Boss Instruments, Ltd. is based in the United States.

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 Boss Instruments, Ltd. manufacture?

Boss Instruments, Ltd. specializes in reusable surgical instruments, including tools like spinal rongeurs for bone removal, hand-held retractors for tissue displacement, retraction system blades for controlled exposure, and various forceps (both scissors-like and tweezers-like) for soft-tissue manipulation. They also produce general-purpose surgical scissors, suturing needle holders, and bulldog clamps, all designed for precision and durability in surgical settings.

Where is Boss Instruments, Ltd. based, and what does that mean for its regulatory standing?

Boss Instruments, Ltd. is headquartered in the United States, which means its devices are subject to FDA regulations. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, indicating compliance with UDI requirements for traceability and transparency in the medical device supply chain. However, regulatory clearance or approval applies to individual devices, not the company itself.

How are Boss Instruments, Ltd.’s devices classified under FDA regulations?

Boss Instruments, Ltd.’s devices fall into two primary FDA classification categories: Class I and Class II. Class I generally includes low-risk devices like basic surgical instruments, while Class II covers those with a moderate risk requiring special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and how it’s used in procedures.

Which regulatory registries or databases list Boss Instruments, Ltd.’s devices?

Boss Instruments, Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device has a unique identifier for tracking, transparency, and compliance with FDA requirements. While the UDI database is a key resource for identifying and verifying devices, it does not indicate regulatory approval—only that the devices meet UDI listing requirements.

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

Information

Country
US
Address
104 Sommerfield Drive, Gordonsville, VA, 22942
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
1000140363
DUNS Number
—

Catalogue (9544)

Page 38 of 191
DeviceModel / ReferenceRegistriesClassStatus
Boss Instruments 70-2281P
FDA UDI
Class IIActive
BOSS Instruments 18-2056
FDA UDI
Class IActive
BOSS Instruments 79-0240
FDA UDI
Class IActive
Boss Instruments 70-0530C
FDA UDI
Class IIActive
BOSS Instruments 77-0823
FDA UDI
Class IActive
BOSS Instruments 81-7071T
FDA UDI
Class IActive
BOSS Instruments 79-0155
FDA UDI
Class IActive
Boss Instruments 70-0694
FDA UDI
Class IIActive
BOSS Instruments 18-4408A
FDA UDI
Class IActive
BOSS Instruments 70-7104
FDA UDI
Class IActive
BOSS Instruments 93-0466
FDA UDI
Class IActive
BOSS Instruments 90-3901
FDA UDI
Class IActive
BOSS Instruments 14-5497
FDA UDI
Class IActive
BOSS Instruments 70-8140
FDA UDI
Class IActive
BOSS Instruments 93-5645
FDA UDI
Class IActive
BOSS Instruments 98-6078
FDA UDI
Class IActive
BOSS Instruments 74-4923T
FDA UDI
Class IActive
Boss Instruments 73-1050
FDA UDI
Class IIActive
BOSS Instruments 50-1157
FDA UDI
Class IActive
BOSS Instruments 73-1514T-1
FDA UDI
Class IIActive
BOSS Instruments 510-6550
FDA UDI
Class IActive
BOSS Instruments 18-4372
FDA UDI
Class IActive
BOSS Instruments 79-0160
FDA UDI
Class IActive
BOSS Instruments 90-4390
FDA UDI
Class IActive
BOSS Instruments 77-1091
FDA UDI
Class IActive
BOSS Instruments 14-1258
FDA UDI
Class IActive
BOSS Instruments 90-7024
FDA UDI
Class IActive
BOSS Instruments 70-8014
FDA UDI
Class IActive
BOSS Instruments 70-7685
FDA UDI
Class IActive
BOSS Instruments 514-1358
FDA UDI
Class IActive
BOSS Instruments 65-6736
FDA UDI
Class IIActive
BOSS Instruments 18-5198
FDA UDI
Class IActive
Boss Instruments 73-1206
FDA UDI
Class IIActive
BOSS Instruments 50-3050
FDA UDI
Class IActive
BOSS Instruments 90-7175
FDA UDI
Class IActive
BOSS Instruments 90-6088
FDA UDI
Class IActive
BOSS Instruments 93-6033
FDA UDI
Class IActive
BOSS Instruments 85-0034
FDA UDI
Class IActive
Boss Instruments 70-0181MP
FDA UDI
Class IIActive
BOSS Instruments 66-1510
FDA UDI
Class IActive
BOSS Instruments 71-5103T
FDA UDI
Class IActive
BOSS Instruments 18-1412
FDA UDI
Class IActive
BOSS Instruments 35-7159
FDA UDI
Class IIActive
BOSS Instruments 98-6345
FDA UDI
Class IActive
BOSS Instruments 93-5632
FDA UDI
Class IActive
BOSS Instruments 93-0160
FDA UDI
Class IActive
BOSS Instruments 96-5704
FDA UDI
Class IActive
BOSS Instruments 70-7722
FDA UDI
Class IActive
Boss Instruments 70-0618P
FDA UDI
Class IIActive
BOSS Instruments 85-0172
FDA UDI
Class IActive

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Boss Instruments, Ltd. has one FDA recall record initiated on 2020-06-26, which is marked as terminated. The recall pertains to a device where the tungsten carbide plate, designed to secure the sewing needle, may break under pressure.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Jun 26, 2020Z-2767-2020—terminated

The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.