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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 41 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Alligator microsurgical scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Quickert lacrimal intubation set | FDA UDI | Class I | Active |
| Ambler Surgical | 25-280 | FDA UDI | Class II | Active |
| Ambler Surgical | Male to male cannula adapter | FDA UDI | Class I | Active |
| Ambler Surgical | Adson tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Farrior ear speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Boucheron ear speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Operating scissors | FDA UDI | Class I | Active |
| Ambler Surgical | 89-436 | FDA UDI | Class II | Active |
| Ambler Surgical | Millard hook and forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Utrata-Kershner capsulorhexis forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Schuknecht stapes hook | FDA UDI | Class I | Active |
| Ambler Surgical | Replacement silicone tubing | FDA UDI | Class I | Active |
| Ambler Surgical | 89-172 | FDA UDI | Class II | Active |
| PST Trays | Mini plastic instrument sterilization tray | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical aluminum instrument sterilization tray | FDA UDI | Class I | Active |
| Ambler Surgical | Rumel tourniquet | FDA UDI | Class I | Active |
| Ambler Surgical | Grooved director | FDA UDI | Class I | Active |
| Ambler Surgical | K-P ring forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Dressing forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Boies septum repositioning elevator | FDA UDI | Class I | Active |
| Ambler Surgical | Flat back spinal fusion curette | FDA UDI | Class I | Active |
| Ambler Surgical | Cobb spinal fusion curette | FDA UDI | Class I | Active |
| Ambler Surgical | Ambler lens manipulator | FDA UDI | Class I | Active |
| Ambler Surgical | Buratto LASIK cannula | FDA UDI | Class I | Active |
| Ambler Surgical | Bone impactor | FDA UDI | Class I | Active |
| Ambler Value Line | Foerster sponge forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Tessier periosteal elevator | FDA UDI | Class I | Active |
| Ambler Surgical | Lexer chisel | FDA UDI | Class I | Active |
| Ambler Surgical | Lewicky anterior chamber maintainer | FDA UDI | Class I | Active |
| Ambler Surgical | Henderson LRI marker | FDA UDI | Class I | Active |
| Ambler Surgical | Langenbeck retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Lamb rasp | FDA UDI | Class I | Active |
| Ambler Surgical | Tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Mini-Thoracotomy retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Friedman micro rongeur | FDA UDI | Class I | Active |
| Ambler Surgical | 76-406 | FDA UDI | Class II | Active |
| Ambler Surgical | Rochester-Pean hemostatic artery forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Mixter dissecting forceps | FDA UDI | Class II | Active |
| Ambler Surgical | Jeweler's-type forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Gelpi self-retaining retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Lieberman tying forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Shoulder percussion awl | FDA UDI | Class I | Active |
| Ambler Surgical | Jacobs chuck drill bit | FDA UDI | Class I | Active |
| Ambler Surgical | Rumel tourniquet | FDA UDI | Class I | Active |
| Ambler Surgical | Grooved director | FDA UDI | Class I | Active |
| Ambler Surgical | Toric combo gravity marker | FDA UDI | Class I | Active |
| Ambler Surgical | Dilator forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Antrum curette | FDA UDI | Class I | Active |
| Ambler Surgical | Faulkner lens folding forceps | FDA UDI | Class I | Active |
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