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Sign in to claim this brandBoss 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
- Website
- bossinstruments.com/
- facebook.com/bossinstruments
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000140363
- DUNS Number
- —
Catalogue (9544)
Page 173 of 191| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BOSS Instruments | 70-7108-11 | FDA UDI | Class I | Active |
| BOSS Instruments | 96-5121 | FDA UDI | Class I | Active |
| BOSS Instruments | 70-8826 | FDA UDI | Class I | Active |
| BOSS Instruments | 93-8036S | FDA UDI | Class I | Active |
| BOSS Instruments | 73-6166 | FDA UDI | Class II | Active |
| BOSS Instruments | 93-0218 | FDA UDI | Class I | Active |
| BOSS Instruments | 73-2557-30 | FDA UDI | Class II | Active |
| BOSS Instruments | 70-4140 | FDA UDI | Class I | Active |
| BOSS Instruments | 70-3504 | FDA UDI | Class I | Active |
| Boss Instruments | 573-1140 | FDA UDI | Class II | Active |
| BOSS Instruments | 30-1019 | FDA UDI | Class I | Active |
| BOSS Instruments | 93-6000 | FDA UDI | Class I | Active |
| BOSS Instruments | 65-6984B | FDA UDI | Class II | Active |
| BOSS Instruments | 65-3031 | FDA UDI | Class I | Active |
| Stealth Surgical | SS4936 | FDA UDI | Class II | Active |
| BOSS Instruments | 90-2112 | FDA UDI | Class I | Active |
| BOSS Instruments | 73-2554 | FDA UDI | Class II | Active |
| BOSS Instruments | 70-3624 | FDA UDI | Class I | Active |
| BOSS Instruments | 70-3500 | FDA UDI | Class I | Active |
| BOSS Instruments | 85-0596 | FDA UDI | Class I | Active |
| BOSS Instruments | 85-0136 | FDA UDI | Class I | Active |
| Boss Instruments | 70-0690SC | FDA UDI | Class II | Active |
| BOSS Instruments | 12-1383 | FDA UDI | Class I | Active |
| BOSS Instruments | 35-8016 | FDA UDI | Class II | Active |
| BOSS Instruments | 18-2017 | FDA UDI | Class I | Active |
| BOSS Instruments | 55-9018 | FDA UDI | Class I | Active |
| BOSS Instruments | 93-0574 | FDA UDI | Class I | Active |
| BOSS Instruments | 50-1537 | FDA UDI | Class I | Active |
| Boss Instruments | 70-0418 | FDA UDI | Class II | Active |
| BOSS Instruments | 65-4050 | FDA UDI | Class I | Active |
| Boss Instruments | 70-0074 | FDA UDI | Class II | Active |
| BOSS Instruments | 93-1301 | FDA UDI | Class I | Active |
| Boss Instruments | 70-1556 | FDA UDI | Class II | Active |
| BOSS Instruments | 66-1512 | FDA UDI | Class I | Active |
| BOSS Instruments | 26-1053-7 | FDA UDI | Class I | Active |
| Stealth Surgical | SS1671941 | FDA UDI | Class II | Active |
| BOSS Instruments | 90-7218 | FDA UDI | Class I | Active |
| BOSS Instruments | 56-9114 | FDA UDI | Class I | Active |
| BOSS Instruments | 71-5108 | FDA UDI | Class I | Active |
| BOSS Instruments | 79-0310 | FDA UDI | Class I | Active |
| BOSS Instruments | 70-7472 | FDA UDI | Class I | Active |
| Boss Instruments | 67-2138 | FDA UDI | Class II | Active |
| BOSS Instruments | 80-8272 | FDA UDI | Class I | Active |
| BOSS Instruments | 80-6155 | FDA UDI | Class I | Active |
| BOSS Instruments | 70-3800 | FDA UDI | Class I | Active |
| BOSS Instruments | 46-2780 | FDA UDI | Class I | Active |
| BOSS Instruments | 80-6114 | FDA UDI | Class I | Active |
| BOSS Instruments | 79-0350 | FDA UDI | Class I | Active |
| BOSS Instruments | 70-7198A | FDA UDI | Class I | Active |
| Boss Instruments | 70-0753SC | FDA UDI | Class II | Active |
Related Companies
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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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 26, 2020 | Z-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. |