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 40 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Simcoe suturing needle | FDA UDI | Class I | Active |
| Ambler Surgical | 17-643 | FDA UDI | Class II | Active |
| Ambler Surgical | Barraquer needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Volkman bone curette | FDA UDI | Class I | Active |
| Ambler Surgical | Cervical axial curette | FDA UDI | Class I | Active |
| Ambler Surgical | 70-811 | FDA UDI | Class II | Active |
| Ambler Surgical | MIS probe | FDA UDI | Class I | Active |
| Ambler Surgical | Bimanual irrigation tip | FDA UDI | Class I | Active |
| Ambler Surgical | Anterior chamber rycroft LASIK cannula | FDA UDI | Class I | Active |
| Ambler Surgical | 31-482-U45 | FDA UDI | Class II | Active |
| Ambler Surgical | Kocher ligature needle | FDA UDI | Class I | Active |
| Ambler Surgical | Dorsey grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Rosenthal-Sinskey reverse hook | FDA UDI | Class I | Active |
| Ambler Surgical | Castroviejo fixation forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Hegar uterine dilator | FDA UDI | Class I | Active |
| Ambler Surgical | Cobb spinal fusion curette | FDA UDI | Class I | Active |
| Ambler Surgical | Brun curette | FDA UDI | Class I | Active |
| Ambler Surgical | Peritoneal scissors | FDA UDI | Class II | Active |
| Ambler Surgical | McPherson-Vannas iris scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Kantrowitz thoracic clamp forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Hook scissors | FDA UDI | Class II | Active |
| Ambler Surgical | Gunderson muscle forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Volkman retractor | FDA UDI | Class I | Active |
| Ambler Surgical | 25-481 | FDA UDI | Class II | Active |
| Ambler Surgical | Chondro micro fracture pick | FDA UDI | Class I | Active |
| Ambler Surgical | LRI slit lamp gravity marker | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical aluminum instrument sterilization tray | FDA UDI | Class I | Active |
| Ambler Surgical | Gruber ear speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Rosen suction tube | FDA UDI | Class I | Active |
| Ambler Surgical | Pylorus spreader forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Kleinsasser-Healy micro laryngeal cup forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Interchangeable-Tip I/A system extra silicone sleeves | FDA UDI | Class I | Active |
| Ambler Surgical | Bone tamper | FDA UDI | Class I | Active |
| Ambler Surgical | Sinskey II lens manipulating hook | FDA UDI | Class I | Active |
| Ambler Surgical | Flat back spinal fusion curette | FDA UDI | Class I | Active |
| Ambler Surgical | 17-475 | FDA UDI | Class II | Active |
| Ambler Surgical | 17-366 | FDA UDI | Class II | Active |
| Ambler Surgical | Webster needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Wilde-type backbitting micro punch forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Jacobson microsurgical scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Casper bone curette | FDA UDI | Class I | Active |
| Ambler Surgical | Minimally invasive heart needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | 70-695 | FDA UDI | Class II | Active |
| Ambler Surgical | 34-345 | FDA UDI | Class II | Active |
| Ambler Surgical | MacGregor conjunctival forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Foerster sponge forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Binkhorst lens holding forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Holinger anterior commissure laryngoscope | FDA UDI | Class I | Active |
| Ambler Value Line | Weitlaner self-retaining retractor | 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.