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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 43 of 191
DeviceModel / ReferenceRegistriesClassStatus
BOSS Instruments 90-1075
FDA UDI
Class IActive
BOSS Instruments 93-8036
FDA UDI
Class IActive
BOSS Instruments 70-7502
FDA UDI
Class IActive
BOSS Instruments 514-5817
FDA UDI
Class IActive
BOSS Instruments 70-7691
FDA UDI
Class IActive
BOSS Instruments 50-1544
FDA UDI
Class IActive
BOSS Instruments 14-1536
FDA UDI
Class IActive
BOSS Instruments 77-0352
FDA UDI
Class IActive
BOSS Instruments 510-6481
FDA UDI
Class IActive
BOSS Instruments 65-5098
FDA UDI
Class IActive
BOSS Instruments 77-0474
FDA UDI
Class IActive
BOSS Instruments 74-5242
FDA UDI
Class IActive
BOSS Instruments 70-7131
FDA UDI
Class IActive
Stealth Surgical SS7362
FDA UDI
Class IIActive
BOSS Instruments 73-0986
FDA UDI
Class IActive
Stealth Surgical SS6039
FDA UDI
Class IIActive
BOSS Instruments 73-3008TB
FDA UDI
Class IIActive
BOSS Instruments 70-8802
FDA UDI
Class IActive
BOSS Instruments 74-4878
FDA UDI
Class IActive
Boss Instruments 70-0969
FDA UDI
Class IIActive
BOSS Instruments 93-1726
FDA UDI
Class IActive
Boss Instruments 67-2150
FDA UDI
Class IIActive
BOSS Instruments 65-2220T
FDA UDI
Class IActive
BOSS Instruments 73-6102
FDA UDI
Class IIActive
BOSS Instruments 73-6126T
FDA UDI
Class IIActive
BOSS Instruments 73-5033
FDA UDI
Class IActive
BOSS Instruments 70-7182-11
FDA UDI
Class IActive
BOSS Instruments 73-6115H
FDA UDI
Class IIActive
BOSS Instruments 73-6060H
FDA UDI
Class IIActive
BOSS Instruments 50-1191
FDA UDI
Class IActive
BOSS Instruments 73-5007
FDA UDI
Class IActive
BOSS Instruments 98-6335
FDA UDI
Class IActive
BOSS Instruments 95-4241
FDA UDI
Class IActive
BOSS Instruments 50-1110
FDA UDI
Class IActive
Boss Instruments 70-1010
FDA UDI
Class IIActive
Boss Instruments 70-2153
FDA UDI
Class IIActive
BOSS Instruments 56-9072
FDA UDI
Class IActive
BOSS Instruments 90-1018
FDA UDI
Class IActive
Boss Instruments 70-0368SC
FDA UDI
Class IIActive
Boss Instruments 65-6410
FDA UDI
Class IIActive
BOSS Instruments 14-5003
FDA UDI
Class IActive
BOSS Instruments 50-2412
FDA UDI
Class IActive
BOSS Instruments 96-5720
FDA UDI
Class IActive
BOSS Instruments 93-6011
FDA UDI
Class IActive
BOSS Instruments 93-0105
FDA UDI
Class IActive
BOSS Instruments 73-6119AH
FDA UDI
Class IIActive
BOSS Instruments 74-5525
FDA UDI
Class IActive
BOSS Instruments 73-0985
FDA UDI
Class IActive
BOSS Instruments 90-3429
FDA UDI
Class IActive
BOSS Instruments 95-9330
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

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.