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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 42 of 363| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ambler Surgical | Troutman-Katzin corneal transplant scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Stevens tenotomy scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Castroviejo corneal section scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Utrata capsulorhexis forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Buie pile clamp | FDA UDI | Class I | Active |
| Ambler Surgical | Hu femtosecond laser forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Kelly dissecting forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Ambler elevator | FDA UDI | Class I | Active |
| Ambler Surgical | 75-767 | FDA UDI | Class II | Active |
| Ambler Surgical | Tupper's universal hand retractor chain holder hooks | FDA UDI | Class I | Active |
| Ambler Surgical | Hamra retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Castroviejo needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Gripper #1 grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Shepard incision irrigating cannula | FDA UDI | Class I | Active |
| Ambler Surgical | Myringotomy sickle blade | FDA UDI | Class I | Active |
| Ambler Surgical | Tupper's universal hand retractor oval box for spare parts | FDA UDI | Class I | Active |
| Ambler Surgical | Weisman-Graves vaginal speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Mayo dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Brophy scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Lempert rongeur | FDA UDI | Class I | Active |
| Ambler Surgical | Mixter dissecting forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Johans grasping forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Adson tissue forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Hook scissors | FDA UDI | Class II | Active |
| Ambler Surgical | 75-976 | FDA UDI | Class II | Active |
| Ambler Surgical | Laryngeal mirror | FDA UDI | Class I | Active |
| Ambler Surgical | Payr ligature guide | FDA UDI | Class I | Active |
| Ambler Surgical | Jackson vaginal retractor | FDA UDI | Class I | Active |
| Ambler Surgical | Mayo dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Stille-Type osteotome | FDA UDI | Class I | Active |
| Ambler Surgical | Jacobson needle holder | FDA UDI | Class I | Active |
| Ambler Surgical | Lalonde skin hook forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Foerster sponge forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Microsurgical artery approximator clamps | FDA UDI | Class II | Active |
| Ambler Surgical | Davis-Mayer mouth gag blade | FDA UDI | Class I | Active |
| Ambler Surgical | Sideport/Groove economy diamond knife | FDA UDI | Class I | Active |
| Ambler Surgical | Lowe-Breck cartilage knife | FDA UDI | Class I | Active |
| Ambler Surgical | Takahashi nasal forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Mannerfelt hook | FDA UDI | Class I | Active |
| Ambler Surgical | Tubal dissecting scissors | FDA UDI | Class I | Active |
| Ambler Value Line | Bowman lacrimal probe | FDA UDI | Class I | Active |
| Ambler Surgical | Lieberman lid speculum | FDA UDI | Class I | Active |
| Ambler Surgical | Dissecting scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Overholt dissecting/ligature forceps | FDA UDI | Class I | Active |
| Ambler Surgical | Nasal sinus scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Ambler microsurgical scissors | FDA UDI | Class I | Active |
| Ambler Surgical | Bimanual irrigation unibody handpiece | FDA UDI | Class I | Active |
| Medin Corporation | Sterilization tray | FDA UDI | Class I | Active |
| Ambler Surgical | Echlin rongeurs | FDA UDI | Class II | Active |
| Ambler Surgical | Rochester-Ochsner hemostatic artery forceps | FDA UDI | Class I | Active |
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