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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 43 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Glassman atraumatic grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Juers-Lempert rongeur | FDA UDI | Class I | Active |
| Ambler Surgical | Sella punch Ceramic-Coat rongeur | FDA UDI | Class II | Active |
| Ambler Value Line | Backhaus towel clamp forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Byrd pocket elevator | FDA UDI | Class I | Active |
| Ambler Surgical | Flat back spinal fusion curette | FDA UDI | Class I | Active |
| Ambler Surgical | 17-398 | FDA UDI | Class II | Active |
| Ambler Surgical | W.M. Lemmon Deaver retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Jacobson microsurgical scissors | FDA UDI | Class I | Active |
| Ambler Surgical | 75-495 | FDA UDI | Class II | Active |
| Ambler Surgical | Mixter forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Adson dura nerve hook | FDA UDI | Class I | Active |
| Ambler Surgical | ArthVance® duckbill basket punch forceps | FDA UDI | Class I | Active |
| Ambler Value Line | Adson tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Lumbar axial curette | FDA UDI | Class I | Active |
| Ambler Surgical | Flora utility scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Fine tying forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Farrell applicator | FDA UDI | Class I | Active |
| Ambler Surgical | Cobra grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Thornton suturing forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Bruser-Kelly scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Johans grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Spinal fusion curette | FDA UDI | Class I | Active |
| Ambler Surgical | Hibbs osteotome | FDA UDI | Class I | Active |
| Ambler Surgical | Biopsy forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Micro sharp forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Kahn-Frazier suction tube | FDA UDI | Class I | Active |
| Ambler Surgical | 89-776 | FDA UDI | Class II | Active |
| Ambler Surgical | Kerrison swivel take-a-part rongeur | FDA UDI | Class I | Active |
| Ambler Surgical | Klintmalm-type liver transplant clamp | FDA UDI | Class I | Active |
| Ambler Surgical | Hibbs osteotome | FDA UDI | Class I | Active |
| Ambler Surgical | Cherry osteotome | FDA UDI | Class I | Active |
| Ambler Surgical | Castroviejo needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Cottle mallet | FDA UDI | Class I | Active |
| Ambler Surgical | Hardy transsphenoidal curette | FDA UDI | Class I | Active |
| Ambler Surgical | 31-185 | FDA UDI | Class II | Active |
| Ambler Surgical | 5757E | FDA UDI | Class II | Active |
| Ambler Surgical | Murphy nerve hook | FDA UDI | Class I | Active |
| Ambler Surgical | Crile-Wood needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Russel-Davis tongue blade | FDA UDI | Class I | Active |
| Ambler Surgical | Casper bone curette | FDA UDI | Class I | Active |
| Ambler Surgical | 70-815 | FDA UDI | Class II | Active |
| Ambler Surgical | Balfour abdominal retractor with ratchet bar | FDA UDI | Class I | Active |
| Ambler Surgical | Castroviejo needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Antrum curette | FDA UDI | Class I | Active |
| Ambler Surgical | Ray pituitary curette | FDA UDI | Class I | Active |
| Ambler Surgical | 25-770 | FDA UDI | Class II | Active |
| Ambler Surgical | Barraquer lid speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Machat PRK/LASIK spatula | FDA UDI | Class I | Active |
| Ambler Surgical | Yancoskie facelift (Rhytidectomy) retractor | FDA UDI | Class I | Active |
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