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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 45 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Ruskin-mini rongeur | FDA UDI | Class I | Active |
| Ambler Surgical | Gerald-DeBakey tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Cottle columella forceps | FDA UDI | Class I | Active |
| Ambler Surgical | DeBakey atraumatic grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Langenbeck retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Laparoscopic trocar port closure/suture retriever guide cone | FDA UDI | Class II | Active |
| Ambler Surgical | Vienna nasal speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Kaye facelift (Rhytidectomy) scissors | FDA UDI | Class I | Active |
| Ambler Surgical | 76-453 | FDA UDI | Class II | Active |
| Ambler Surgical | 75-220 | FDA UDI | Class II | Active |
| Ambler Surgical | Vidaurri LASIK retreatment spatula | FDA UDI | Class I | Active |
| Ambler Surgical | Castroviejo corneal scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Ambler microsurgical scissors | FDA UDI | Class I | Active |
| Ambler Surgical | 76-103 | FDA UDI | Class II | Active |
| Ambler Surgical | Kleinert-Kutz rasp | FDA UDI | Class I | Active |
| Ambler Surgical | Jako micro laryngeal knife | FDA UDI | Class I | Active |
| Ambler Surgical | Hibbs gouge | FDA UDI | Class I | Active |
| Ambler Surgical | O'Gawa suture-fixation forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Strumpel-Voss nasal forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 31-869 | FDA UDI | Class II | Active |
| Ambler Surgical | Microsurgical forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 75-887 | FDA UDI | Class II | Active |
| Ambler Surgical | Kalt needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Lindstrom lens insertion forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Alm retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Castroviejo needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | 25-758 | FDA UDI | Class II | Active |
| Ambler Surgical | Lalonde skin hook forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Metzenbaum dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Interchangeable-Tip I/A system 90 degrees angled tip | FDA UDI | Class I | Active |
| Ambler Surgical | Cleaning/flushing kit | FDA UDI | Class I | Active |
| Ambler Surgical | Dolphin dissecting/grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Stubbs adenoid curette | FDA UDI | Class I | Active |
| Ambler Surgical | Partsch gouge | FDA UDI | Class I | Active |
| Ambler Surgical | Spencer-Wells artery forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Maryland dissecting forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Levasseur-Merrill retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Kolbel glenoid retractor/level | FDA UDI | Class I | Active |
| Ambler Surgical | Jackson laryngeal alligator grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 75-871 | FDA UDI | Class II | Active |
| Ambler Surgical | 34-356 | FDA UDI | Class II | Active |
| Ambler Surgical | Maryland dissecting forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Collins tissue forceps | FDA UDI | Class I | Active |
| Ambler Value Line | Adson dressing forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 27-308RG | FDA UDI | Class II | Active |
| Ambler Surgical | Microsurgical dressing forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Akahoshi hybrid combo prechopper forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Ambler alligator ear forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Jameson scissors | FDA UDI | Class I | Active |
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