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Sign in to claim this brandAmbler Surgical, LLC
US
Last updated September 17, 2026
What Ambler Surgical, LLC makes
Ambler Surgical, LLC manufactures reusable surgical instruments, including needle holders, bipolar electrosurgical handpieces, general-purpose scissors, retractors, forceps, endoscopic forceps, spinal rongeurs, and bone curettes. These tools are designed for open surgery and endoscopic procedures, supporting tissue manipulation, dissection, and spinal applications.
The company’s products are regulated under FDA’s 510(k) premarket notification process, with devices classified as Class I and Class II. They are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.
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 Ambler Surgical, LLC manufacture?
Ambler Surgical, LLC specializes in reusable surgical instruments used in both open-surgery and endoscopic procedures. Their product line includes suturing needle holders, bipolar electrosurgical handpieces, general-purpose surgical scissors, hand-held retractors, dressing/utility forceps, rigid endoscopic tissue manipulation forceps, spinal rongeurs, and bone curettes. These tools are designed for precision tasks like tissue manipulation, dissection, and spinal applications.
Where is Ambler Surgical, LLC based?
Ambler Surgical, LLC is based in the United States. The company’s location aligns with U.S. regulatory requirements, including compliance with FDA guidelines for medical devices.
Which regulatory registries or databases list Ambler Surgical’s devices?
Ambler Surgical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for their reusable surgical instruments, helping healthcare providers verify compliance and product details.
How are Ambler Surgical’s devices classified under FDA regulations?
Ambler Surgical’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require less stringent regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as the 510(k) premarket notification process, which ensures these instruments meet FDA standards before entering the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 436 Creamery Way Ste 300, EXTON, PA, 19341
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3005528784
- DUNS Number
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Catalogue (18102)
Page 46 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Mayo-Sims dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Iris scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Hibbs gouge | FDA UDI | Class I | Active |
| Ambler Surgical | Knapp self-retaining retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Brun (Spratt) bone curette | FDA UDI | Class I | Active |
| Ambler Surgical | 76-802 | FDA UDI | Class II | Active |
| Ambler Surgical | Mayo-Hegar needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Flat nose pliers | FDA UDI | Class I | Active |
| Ambler Surgical | Spinal fusion osteotome | FDA UDI | Class I | Active |
| Ambler Surgical | Deschamps ligature carrier | FDA UDI | Class I | Active |
| Ambler Value Line | DeBakey needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Austin excavator | FDA UDI | Class I | Active |
| Ambler Surgical | Goodhill ear forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Huffman-Graves vaginal speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Tubal dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Metzenbaum dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Duet-style MICS Suh capsulotomy scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Krause ear snare replacement wire | FDA UDI | Class I | Active |
| Ambler Surgical | Metzenbaum dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Zielke rongeur | FDA UDI | Class I | Active |
| Ambler Surgical | Tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Knapp strabismus scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Jacobson microsurgical scissors | FDA UDI | Class I | Active |
| Ambler Value Line | Iris scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Wiltse-Gelpi self-retaining retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Keyes dermal punch | FDA UDI | Class I | Active |
| Ambler Surgical | Deschamps ligature carrier | FDA UDI | Class I | Active |
| Ambler Surgical | Brun (Spratt) bone curette | FDA UDI | Class I | Active |
| Ambler Surgical | Kerrison swivel take-a-part rongeur | FDA UDI | Class I | Active |
| Ambler Surgical | Wullstein-Weitlaner self-retaining retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Ferris-Smith-Sewall orbital retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Kerrison ejector rongeur | FDA UDI | Class II | Active |
| Ambler Surgical | Deaver retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Breisky vaginal retractor | FDA UDI | Class I | Active |
| Ambler Surgical | R-Style micro dissector | FDA UDI | Class I | Active |
| Ambler Surgical | Myringotomy lance blade | FDA UDI | Class I | Active |
| Ambler Surgical | 45-225 | FDA UDI | Class II | Active |
| Ambler Surgical | 17-664 | FDA UDI | Class II | Active |
| Ambler Surgical | Ryder micro needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Barnhill adenoid curette | FDA UDI | Class I | Active |
| Ambler Surgical | Ballenger chisel | FDA UDI | Class I | Active |
| Ambler Surgical | 89-427 | FDA UDI | Class II | Active |
| Ambler Surgical | Metzenbaum dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Kaye facelift (Rhytidectomy) scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Pin pulling pliers | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Cushing tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Flieringa fixation ring | FDA UDI | Class I | Active |
| Ambler Surgical | Metzenbaum dissecting scissors | FDA UDI | Class I | Active |
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