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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 49 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Adlerkreutz tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Gruenwald-Jansen nasal tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Miniature angled round tip sharp all around blade | FDA UDI | Class I | Active |
| Ambler Surgical | Mermoud schlemm's canal tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Jones I.M.A. diamond knife | FDA UDI | Class I | Active |
| Ambler Surgical | Metzenbaum dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Curette excavator | FDA UDI | Class I | Active |
| Ambler Surgical | Jackson direct or anterior commissure laryngoscope | FDA UDI | Class I | Active |
| Ambler Surgical | Iris/utility scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Kerrison swivel take-a-part rongeur | FDA UDI | Class I | Active |
| Ambler Surgical | 75-390 | FDA UDI | Class II | Active |
| Ambler Surgical | 70-679 | FDA UDI | Class II | Active |
| Ambler Surgical | Swiss osteotome | FDA UDI | Class I | Active |
| Ambler Surgical | Tebbetts-style breast dissector | FDA UDI | Class I | Active |
| Ambler Surgical | 25-431 | FDA UDI | Class II | Active |
| Ambler Surgical | Fletcher sponge forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Wiles MICS hydrodissection cannula | FDA UDI | Class I | Active |
| Ambler Surgical | Sideport/Groove sapphire knife | FDA UDI | Class I | Active |
| Ambler Surgical | Kerrison swivel take-a-part rongeur | FDA UDI | Class I | Active |
| Ambler Surgical | C76-903 | FDA UDI | Class II | Active |
| Ambler Surgical | Feaster lens holding forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Barraquer needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Russel-Davis tongue blade | FDA UDI | Class I | Active |
| Ambler Surgical | Strabismus scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Fukasaku ''hockey'' knife | FDA UDI | Class I | Active |
| Ambler Surgical | Sarot artery forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Schott lid speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Israel retractor | FDA UDI | Class I | Active |
| Ambler Surgical | 5754E | FDA UDI | Class II | Active |
| Ambler Surgical | Jako micro laryngeal scissors | FDA UDI | Class I | Active |
| Ambler Surgical | C76-507 | FDA UDI | Class II | Active |
| Ambler Surgical | 75-682 | FDA UDI | Class II | Active |
| Ambler Surgical | Singley (Tuttle) tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Iris/tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Brun (Spratt) bone curette | FDA UDI | Class I | Active |
| Ambler Surgical | Stille-Type bone chisel | FDA UDI | Class I | Active |
| Ambler Surgical | Rake finger retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Berci fascial closure instrument | FDA UDI | Class I | Active |
| Ambler Surgical | 17-531 | FDA UDI | Class II | Active |
| Ambler Surgical | Maumenee vitreous aspirating needle | FDA UDI | Class I | Active |
| Ambler Surgical | Van-Buren urethral sound | FDA UDI | Class I | Active |
| Ambler Value Line | Pratt fistula probe | FDA UDI | Class I | Active |
| Ambler Surgical | Davis root tip pick | FDA UDI | Class I | Active |
| Ambler Surgical | Freeman facelift (Rhytidectomy) scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Rees bulldog scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Mini-Friedman ronguer | FDA UDI | Class I | Active |
| Ambler Surgical | 17-484 | FDA UDI | Class II | Active |
| Ambler Surgical | Metzenbaum dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Jensen capsule polisher cannula | FDA UDI | Class I | Active |
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