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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 39 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Freer septum ''E'' knife | FDA UDI | Class I | Active |
| Ambler Surgical | Gerald-DeBakey tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Sarnicola DALK big bubble spatula | FDA UDI | Class I | Active |
| Ambler Surgical | Barraquer needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Shapleigh ear curette | FDA UDI | Class I | Active |
| Ambler Surgical | 17-326 | FDA UDI | Class II | Active |
| Ambler Surgical | Raney clip applying forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Overholt dissecting/ligature forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 89-780 | FDA UDI | Class II | Active |
| Ambler Surgical | Micro skin hook | FDA UDI | Class I | Active |
| Ambler Surgical | 26-040 | FDA UDI | Class II | Active |
| Ambler Surgical | Kocher-Landenbeck retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Bakes common bile duct dilators | FDA UDI | Class I | Active |
| PST Trays | Plastic scope sterilization tray | FDA UDI | Class I | Active |
| Ambler Surgical | DeBakey vascular scissors | FDA UDI | Class I | Active |
| Ambler Surgical | 26-660 | FDA UDI | Class II | Active |
| Ambler Surgical | Tucker mid-lighted side slide laryngoscope | FDA UDI | Class I | Active |
| Ambler Surgical | Hasson ''S'' retractor | FDA UDI | Class I | Active |
| Ambler Surgical | 75-322 | FDA UDI | Class II | Active |
| Ambler Surgical | Martin tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Hoffer-Stern scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Corneal trephine blade | FDA UDI | Class I | Active |
| Ambler Surgical | Willauer scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Tibolt punctal scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Bellucci miniature scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Beaver knife handle | FDA UDI | Class I | Active |
| Ambler Surgical | Joseph nasal knife | FDA UDI | Class I | Active |
| Ambler Surgical | Kolbel self-retaining retractor blade only | FDA UDI | Class I | Active |
| Ambler Surgical | Henly retractor side blades | FDA UDI | Class I | Active |
| Ambler Surgical | Adson hemostatic forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Ambler vascular/artery scissors | FDA UDI | Class I | Active |
| Ambler Surgical | 70-883 | FDA UDI | Class II | Active |
| Ambler Surgical | Pisacano nucleus rotator | FDA UDI | Class I | Active |
| Ambler Surgical | Buck ear curette | FDA UDI | Class I | Active |
| Ambler Surgical | Gills-Welsh aspirating cannula | FDA UDI | Class I | Active |
| Ambler Surgical | Lahey gall duct forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Dressing forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Spring wire retractor | FDA UDI | Class I | Active |
| Ambler Surgical | LRI diamond knife | FDA UDI | Class I | Active |
| Ambler Value Line | Cushing dressing forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 25-892 | FDA UDI | Class II | Active |
| Ambler Surgical | DeBakey vascular needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | 70-707 | FDA UDI | Class II | Active |
| Ambler Surgical | Freeman areola marker | FDA UDI | Class I | Active |
| Ambler Surgical | Rowe maxillary disimpaction forceps | FDA UDI | Class I | Active |
| Ambler Surgical | 75-816 | FDA UDI | Class II | Active |
| Ambler Surgical | 25-380 | FDA UDI | Class II | Active |
| Ambler Surgical | Catalano micro tying forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Binkhorst irrigating cannula | FDA UDI | Class I | Active |
| Ambler Surgical | Anderson-Neivert osteotome | FDA UDI | Class I | Active |
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