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 48 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | McPherson tying forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 76-774 | FDA UDI | Class II | Active |
| Ambler Surgical | Singley (Tuttle) tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Davis grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 76-927 | FDA UDI | Class II | Active |
| Ambler Surgical | 70-880 | FDA UDI | Class II | Active |
| Ambler Surgical | 89-678 | FDA UDI | Class II | Active |
| Ambler Surgical | Metzenbaum dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | 76-652 | FDA UDI | Class II | Active |
| Ambler Surgical | 26-552 | FDA UDI | Class II | Active |
| Ambler Surgical | Kuhn nasal cutting forceps | FDA UDI | Class I | Active |
| Ambler Value Line | Metzenbaum dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | McCulloch-type manipulation hook probe | FDA UDI | Class I | Active |
| Ambler Surgical | 75-681 | FDA UDI | Class II | Active |
| Ambler Surgical | 76-356 | FDA UDI | Class II | Active |
| Ambler Surgical | Blunt jaw pliers | FDA UDI | Class I | Active |
| Ambler Surgical | Jacobson needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Manche LASIK forceps | FDA UDI | Class I | Active |
| Ambler Surgical | D'Assumpcao facelift (Rhytidectomy) marking forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Alligator grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Keratome black diamond knife | FDA UDI | Class I | Active |
| Ambler Surgical | Stille-Type bone chisel | FDA UDI | Class I | Active |
| Ambler Surgical | Tubal microsurgical approximator double clamps | FDA UDI | Class I | Active |
| Ambler Surgical | Sideport/Groove Trapezoid diamond knife | FDA UDI | Class I | Active |
| Ambler Surgical | VATS thoracoscopic dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Matarasso facelift (Rhytidectomy) scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Spencer stitch scissors | FDA UDI | Class I | Active |
| Ambler Surgical | 75-700 | FDA UDI | Class II | Active |
| Ambler Value Line | Weitlaner self-retaining retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Hibbs gouge | FDA UDI | Class I | Active |
| Ambler Surgical | Ziegler knife needle | FDA UDI | Class I | Active |
| Ambler Surgical | Mixter hemostatic forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Johans grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | DeBakey microsurgical tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Jacobson slim-line needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Lambotte osteotome | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical general purpose single clamps | FDA UDI | Class II | Active |
| Ambler Surgical | DeBakey vascular scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Heifetz brain spatula | FDA UDI | Class I | Active |
| Ambler Surgical | 76-920 | FDA UDI | Class II | Active |
| Ambler Surgical | DSAEK descemet's membrane stripper replacement handle only | FDA UDI | Class I | Active |
| Ambler Surgical | Kirby-Barraquer fixation forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 70-882 | FDA UDI | Class II | Active |
| Ambler Surgical | 75-974 | FDA UDI | Class II | Active |
| Ambler Surgical | 76-871 | FDA UDI | Class II | Active |
| Ambler Surgical | 72-556 | FDA UDI | Class II | Active |
| Ambler Surgical | Bimanual aspiration unibody handpiece | FDA UDI | Class I | Active |
| Ambler Surgical | House strut pick | FDA UDI | Class I | Active |
| Ambler Surgical | Uebe applicator | 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.