Is this your brand? Sign in to claim ownership.
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
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3005528784
- DUNS Number
- —
Catalogue (18102)
Page 37 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Killian-Walter nasal speculum 5 1/2'' | FDA UDI | Class I | Active |
| Ambler Surgical | Tissue nipper forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Joseph nasal bone saw | FDA UDI | Class I | Active |
| Ambler Surgical | 89-641 | FDA UDI | Class II | Active |
| Ambler Surgical | Metzenbaum dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Petelin dissecting forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Jako micro laryngeal alligator forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Cummings universal retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Gorney-Freeman facelift (Rhytidectomy) scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Landolt enucleator | FDA UDI | Class I | Active |
| Ambler Surgical | 26-056 | FDA UDI | Class II | Active |
| Ambler Surgical | Malis-type forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Dandy hemostatic forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Stevens tenotomy scissors | FDA UDI | Class I | Active |
| Ambler Surgical | 76-601 | FDA UDI | Class II | Active |
| Ambler Surgical | Farabeuf periosteal raspatory | FDA UDI | Class I | Active |
| Ambler Surgical | 33-289 | FDA UDI | Class II | Active |
| Ambler Surgical | Rochester-Pean hemostatic artery forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Gripper #1 grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | IOL lens manipulator | FDA UDI | Class I | Active |
| Ambler Surgical | Collin-Duval grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Tebbetts-style breast retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Hall III lens inserting forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 76-934 | FDA UDI | Class II | Active |
| Ambler Surgical | Ambler vascular/artery scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Martin tornado plaster shears | FDA UDI | Class I | Active |
| Ambler Surgical | 75-531 | FDA UDI | Class II | Active |
| Ambler Surgical | Hydrodissection cannula | FDA UDI | Class I | Active |
| Ambler Surgical | Cottle retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Euphrate-Pasqu needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Biopsy and grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Colibri forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Volkman retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Mayo-Hegar needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Kocher-Landenbeck retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Lester fixation forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Shepard tying forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Harms colibri forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Gerald-DeBakey tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Breisky vaginal retractor | FDA UDI | Class I | Active |
| Ambler Surgical | 75-370 | FDA UDI | Class II | Active |
| Ambler Surgical | Heiss wound retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Intra-Cardiac needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | 71-112 | FDA UDI | Class II | Active |
| Ambler Surgical | Microsurgical forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Lester lens manipulator | FDA UDI | Class I | Active |
| Ambler Surgical | Bishop-Harmon irrigating cannula | FDA UDI | Class I | Active |
| Ambler Surgical | Van-Buren urethral sound | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.