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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 47 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Corneal trephine blade | FDA UDI | Class I | Active |
| Ambler Surgical | Brain spatula | FDA UDI | Class I | Active |
| Ambler Surgical | Vienna nasal speculum | FDA UDI | Class I | Active |
| Ambler Surgical | 75-431 | FDA UDI | Class II | Active |
| Ambler Surgical | Henly retractor | FDA UDI | Class I | Active |
| Ambler Surgical | 70-854 | FDA UDI | Class II | Active |
| Ambler Value Line | Weil-Blakesley sinus forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Cushing vein retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Allis-Judd tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Girard tying forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Quervian elevator | FDA UDI | Class I | Active |
| Ambler Surgical | Williger curette | FDA UDI | Class I | Active |
| Ambler Surgical | Fox dermal curette | FDA UDI | Class I | Active |
| Ambler Surgical | Cobb spinal fusion curette | FDA UDI | Class I | Active |
| Ambler Surgical | Cushing bipolar forceps | FDA UDI | Class II | Active |
| Ambler Surgical | Karlin microdiscectomy cervical curette | FDA UDI | Class I | Active |
| Ambler Surgical | Yasargil-Samii forceps | FDA UDI | Class I | Active |
| PST Trays | Replacement silicone bar | FDA UDI | Class I | Active |
| Ambler Surgical | Iris scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Westcott stitch scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Adventitia microsurgical dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | 75-875 | FDA UDI | Class II | Active |
| Ambler Surgical | Watson skin graft knife replacement blade | FDA UDI | Class I | Active |
| Ambler Surgical | Hibbs gouge | FDA UDI | Class I | Active |
| Ambler Surgical | Grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | MicroGlide MIS bipolar forceps | FDA UDI | Class II | Active |
| Ambler Surgical | Retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Jacobson needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | French eye needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Williger curette | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical general purpose approximator clamps | FDA UDI | Class II | Active |
| Ambler Surgical | Rochester-Pean hemostatic artery forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Arruga capsule forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 76-680 | FDA UDI | Class II | Active |
| Ambler Surgical | Middledorpf retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Ambler microsurgical scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Echlin rongeurs | FDA UDI | Class II | Active |
| Ambler Surgical | Mayo-Hegar needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Sedillot periosteal elevator | FDA UDI | Class I | Active |
| Ambler Surgical | Spinal fusion curette | FDA UDI | Class I | Active |
| Ambler Surgical | 89-366 | FDA UDI | Class II | Active |
| Ambler Surgical | Frazier cord knife | FDA UDI | Class I | Active |
| Ambler Surgical | Sickle knife | FDA UDI | Class I | Active |
| Ambler Surgical | Alexander mastoid gouge | FDA UDI | Class I | Active |
| Ambler Surgical | Marques grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Griffiths-Brown tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Irrigating cystotome | FDA UDI | Class I | Active |
| Ambler Surgical | Katzin-Barraquer colibri corneal utility forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 76-654 | FDA UDI | Class II | Active |
| Ambler Surgical | Utility and sterilizer forceps | FDA UDI | Class I | Active |
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