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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 38 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Kratz lens manipulating cannula | FDA UDI | Class I | Active |
| Ambler Surgical | Cooley atrial valve retractor | FDA UDI | Class I | Active |
| Ambler Surgical | 6225E | FDA UDI | Class II | Active |
| Ambler Surgical | Tonsil forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Tennant tying forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Rochester-Ochsner hemostatic artery forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Gerald tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Hill prechopper forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 70-361 | FDA UDI | Class II | Active |
| Ambler Surgical | Kratz lens holding forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 17-422 | FDA UDI | Class II | Active |
| Ambler Value Line | Bowman lacrimal probe | FDA UDI | Class I | Active |
| Ambler Surgical | Karlin microdiscectomy cervical curette | FDA UDI | Class I | Active |
| Ambler Surgical | Quick coupling tap | FDA UDI | Class I | Active |
| Ambler Surgical | 17-471 | FDA UDI | Class II | Active |
| Ambler Surgical | Hegar uterine dilator | FDA UDI | Class I | Active |
| Ambler Surgical | 25-680 | FDA UDI | Class II | Active |
| Ambler Surgical | O'Gawa-Utrata capsulorhexis forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Potts-Smith scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Wullstein-Weitlaner self-retaining retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Quickert lacrimal intubation probe | FDA UDI | Class I | Active |
| Ambler Surgical | 34-336 | FDA UDI | Class II | Active |
| Ambler Surgical | Stainless steel breakable blades | FDA UDI | Class I | Active |
| Ambler Surgical | Cobb spinal fusion curette | FDA UDI | Class I | Active |
| Ambler Surgical | Zenker ligature forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Spinal fusion osteotome | FDA UDI | Class I | Active |
| Ambler Surgical | McCulloch-type elevator | FDA UDI | Class I | Active |
| Ambler Value Line | Crile-Wood needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | 17-575 | FDA UDI | Class II | Active |
| Ambler Surgical | Tendon stripper | FDA UDI | Class I | Active |
| Ambler Surgical | Brun curette | FDA UDI | Class I | Active |
| Ambler Surgical | Kratz-Barraquer lid speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Air injection cannula | FDA UDI | Class I | Active |
| Ambler Surgical | Hump osteotome | FDA UDI | Class I | Active |
| Ambler Surgical | Tebbetts-style breast dissector | FDA UDI | Class I | Active |
| Ambler Surgical | Providence hospital artery forceps | FDA UDI | Class I | Active |
| Ambler Surgical | DeBakey needle holder | FDA UDI | Class I | Active |
| Ambler Value Line | DeBakey vascular tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Anis radial marker | FDA UDI | Class I | Active |
| Ambler Surgical | 18-291 | FDA UDI | Class II | Active |
| Ambler Surgical | 89-444 | FDA UDI | Class II | Active |
| Ambler Surgical | Utility plaster shears | FDA UDI | Class I | Active |
| Ambler Surgical | 29-252 | FDA UDI | Class II | Active |
| Ambler Surgical | Kerrison swivel take-a-part rongeur | FDA UDI | Class I | Active |
| Ambler Surgical | Jacobson slim-line needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Endarterectomy spatula | FDA UDI | Class I | Active |
| Ambler Surgical | Arnold lid speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Vannas scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Initial incision retractor long blade only | FDA UDI | Class I | Active |
| Ambler Surgical | McCapherty pusher | FDA UDI | Class I | Active |
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