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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 44 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Slade LASIK lid speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Freeman brow lift retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Jacobson needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | 44-546 | FDA UDI | Class II | Active |
| Ambler Surgical | Krause nasal snare replacement cannula | FDA UDI | Class I | Active |
| Ambler Surgical | Thudichum nasal speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Kelly retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Frazier suction tube | FDA UDI | Class II | Active |
| Ambler Surgical | 76-034 | FDA UDI | Class II | Active |
| Ambler Surgical | Mixter forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Jackson tracheal tube | FDA UDI | Class I | Active |
| Ambler Surgical | Duval grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Hugonnier-Gobin strabismus hook | FDA UDI | Class I | Active |
| Ambler Surgical | Micro-S curette | FDA UDI | Class I | Active |
| Ambler Surgical | Snitman self-retaining enduaral retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Caspar nerve root retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Jayes osteotome | FDA UDI | Class I | Active |
| Ambler Surgical | 17-705 | FDA UDI | Class II | Active |
| Ambler Surgical | Castroviejo suturing forceps | FDA UDI | Class I | Active |
| Medin Corporation | Replacement silicone finger mat | FDA UDI | Class I | Active |
| Ambler Surgical | Ferguson-Frazier suction tube | FDA UDI | Class I | Active |
| Ambler Surgical | Jameson scissors | FDA UDI | Class I | Active |
| Ambler Surgical | 2045E | FDA UDI | Class II | Active |
| Ambler Surgical | 25-846 | FDA UDI | Class II | Active |
| Ambler Surgical | Bimanual aspiration tip | FDA UDI | Class I | Active |
| Ambler Surgical | Potts-Smith dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Tonsil forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Kerrison ejector rongeur | FDA UDI | Class II | Active |
| Ambler Surgical | MicroGlide MIS bipolar forceps | FDA UDI | Class II | Active |
| Ambler Surgical | Intraocular scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Hough stapedectomy foot plate pick | FDA UDI | Class I | Active |
| Ambler Surgical | House cutoff adapter | FDA UDI | Class I | Active |
| Ambler Surgical | Diethrich coronary artery scissors | FDA UDI | Class I | Active |
| Ambler Value Line | Volkman retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Lambotte bone holding forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 30-963 | FDA UDI | Class II | Active |
| Ambler Surgical | Weil-Blakesley sinus forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 15 degree stab knife | FDA UDI | Class I | Active |
| Ambler Surgical | 17-431 | FDA UDI | Class II | Active |
| Ambler Surgical | Gross ear hook and spoon | FDA UDI | Class I | Active |
| Ambler Surgical | Sideport/Groove sapphire knife | FDA UDI | Class I | Active |
| Ambler Surgical | 89-591 | FDA UDI | Class II | Active |
| Ambler Surgical | Epker osteotome | FDA UDI | Class I | Active |
| Ambler Surgical | 89-773 | FDA UDI | Class II | Active |
| Ambler Surgical | Enucleation scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Metzenbaum dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Myringotomy spear micro-point blade | FDA UDI | Class I | Active |
| Ambler Surgical | Duet-style MICS Ahmed needle holder | FDA UDI | Class I | Active |
| PST Trays | Plastic scope sterilization tray | FDA UDI | Class I | Active |
| Ambler Surgical | Gorney plastic surgery scissors | FDA UDI | Class I | Active |
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