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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 179 of 191
DeviceModel / ReferenceRegistriesClassStatus
BOSS Instruments 90-3428
FDA UDI
Class IActive
BOSS Instruments 56-9088
FDA UDI
Class IActive
BOSS Instruments 26-1001
FDA UDI
Class IActive
BOSS Instruments 73-6058H
FDA UDI
Class IIActive
BOSS Instruments 80-6260
FDA UDI
Class IActive
Boss Instruments 70-0394
FDA UDI
Class IIActive
BOSS Instruments 55-9017
FDA UDI
Class IActive
Boss Instruments 70-0370SC
FDA UDI
Class IIActive
BOSS Instruments 550-1503
FDA UDI
Class IActive
BOSS Instruments 50-1535
FDA UDI
Class IActive
BOSS Instruments 93-1019
FDA UDI
Class IActive
BOSS Instruments 73-3375P
FDA UDI
Class IActive
Boss Instruments 73-1062
FDA UDI
Class IIActive
BOSS Instruments 72-6301
FDA UDI
Class IActive
BOSS Instruments 70-6906
FDA UDI
Class IActive
BOSS Instruments 80-8182
FDA UDI
Class IActive
BOSS Instruments 73-8060T
FDA UDI
Class IIActive
BOSS Instruments 70-7200A
FDA UDI
Class IActive
Boss Instruments 70-2845
FDA UDI
Class IIActive
BOSS Instruments 65-5194T
FDA UDI
Class IActive
BOSS Instruments 26-1204
FDA UDI
Class IActive
BOSS Instruments 65-5066
FDA UDI
Class IActive
BOSS Instruments 18-3252
FDA UDI
Class IActive
BOSS Instruments 14-1322
FDA UDI
Class IActive
Stealth Surgical SS0850T
FDA UDI
Class IIActive
BOSS Instruments 93-7120
FDA UDI
Class IActive
BOSS Instruments 93-0060
FDA UDI
Class IActive
BOSS Instruments 90-3302
FDA UDI
Class IActive
Boss Instruments 70-1231
FDA UDI
Class IIActive
BOSS Instruments 90-7104
FDA UDI
Class IActive
BOSS Instruments 88-0364
FDA UDI
Class IActive
BOSS Instruments 73-8032
FDA UDI
Class IIActive
BOSS Instruments 70-4106
FDA UDI
Class IActive
Boss Instruments 70-1347
FDA UDI
Class IIActive
BOSS Instruments 593-0227
FDA UDI
Class IActive
BOSS Instruments 26-0992
FDA UDI
Class IActive
BOSS Instruments 65-9200
FDA UDI
Class IActive
BOSS Instruments 14-1358
FDA UDI
Class IActive
BOSS Instruments 90-7120P
FDA UDI
Class IActive
BOSS Instruments 90-4550
FDA UDI
Class IActive
BOSS Instruments 88-0395
FDA UDI
Class IActive
BOSS Instruments 35-9157L
FDA UDI
Class IActive
BOSS Instruments 90-7070
FDA UDI
Class IActive
Boss Instruments 70-0730SC
FDA UDI
Class IIActive
BOSS Instruments 90-3202
FDA UDI
Class IActive
BOSS Instruments 50-1135
FDA UDI
Class IActive
BOSS Instruments 90-2045
FDA UDI
Class IActive
BOSS Instruments 70-3609
FDA UDI
Class IActive
BOSS Instruments 73-6147H
FDA UDI
Class IIActive
BOSS Instruments 70-3947
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.