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Sign in to claim this brandAmerican Surgical Company, LLC
United States·US-MF-000007259
Last updated September 17, 2026
About
Absorbent, single-use surgical tools, for use across a wide array of medical specialties. Our patties are all made in the United States.
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 100 , Cummings Center, Beverly, United States
- Website
- www.americansurgical.com
- —
- [email protected]
- Phone
- 1 781 592 7200
- PRRC Contact
- Amanda Lemus
- EUDAMED SRN
- US-MF-000007259
- FDA FEI Number
- 1221144
- DUNS Number
- —
Catalogue (192)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Telfa | 80-22 | FDA UDI | Class II | Active |
| Peanut | 40-03A | FDA UDI | Class I | Active |
| Delicot | 63-07 | FDA UDI | Class II | Active |
| Uniqcot | 67-05 | FDA UDI | Class II | Active |
| Comfort Pack | 110-01 | FDA UDI | N/A | Active |
| Uniqcot | 67-13 | FDA UDI | Class II | Active |
| Cylindrical Sponge | 70-05 | FDA UDI | Class I | Active |
| Ultracot | 23-24 | FDA UDI | Class II | Active |
| Cotton Balls | 30-00 | FDA UDI | Class I | Active |
| Ultracot | 23-16 | FDA UDI | Class II | Active |
| Tapered Delicot | 63-11T | FDA UDI | Class II | Active |
| ArmourSorb | 88-29 | FDA UDI | Class II | Active |
| Ultracot | 23-15 | FDA UDI | Class II | Active |
| Ultracot | 23-09 | FDA UDI | Class II | Active |
| Ray-Cot | 60-12 | FDA UDI | Class II | Active |
| Ray-Cot | 61-04 | FDA UDI | Class II | Active |
| ArmourSorb | 88-05 | FDA UDI | Class II | Active |
| Custom Telfa Pack | 82-01 | FDA UDI | Class II | Active |
| Telfa | 81-06 | FDA UDI | Class II | Active |
| Tonsil Sponges | 50-01 | FDA UDI | U | Active |
| ArmourSorb | 88-09 | FDA UDI | Class II | Active |
| Tapered Delicot | 63-07T | FDA UDI | Class II | Active |
| Telfa | 81-11 | FDA UDI | Class II | Active |
| Ray-Cot | 60-05 | FDA UDI | Class II | Active |
| Kittner | 45-01 | FDA UDI | U | Active |
| Atlas Choice Cranial Pattie Collection | 300-01 | FDA UDI | Class II | Active |
| Telfa | 81-13 | FDA UDI | Class II | Active |
| Americot | 20-01S | EUDAMEDFDA UDI | Class III | Active |
| ASM-301 Level 3 Surgical Mask | K211440 | FDA 510(k) | Class II | Active |
| Amer. Surgical Corp. Extra Plus Pak | K841738 | FDA 510(k) | Class II | Active |
| American Surgical Company/ Neurosurgical Sponges (brand) | K112598 | FDA 510(k) | Class II | Active |
| Extra Plus Tm | K833617 | FDA 510(k) | Class II | Active |
| Vitreonic Plus | K834160 | FDA 510(k) | Class II | Active |
| Universal Pac | K834161 | FDA 510(k) | Class II | Active |
| Extra Sensory Plus | K834158 | FDA 510(k) | Class II | Active |
| Vit Pac | K834162 | FDA 510(k) | Class II | Active |
| Phacotron Plus | K834159 | FDA 510(k) | Class II | Active |
| Extra Sensory Pak-Dispos. Access | K833697 | FDA 510(k) | Class II | Active |
| Ultravit | K834163 | FDA 510(k) | Class II | Active |
| Delicot | K121822 | FDA 510(k) | Class II | Active |
| Cotton Balls | 31-07 | EUDAMEDFDA UDI | Class IIa | Active |
| Uniqcot | 67-07 | EUDAMEDFDA UDI | Class III | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (92)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 18, 2024 | Z-0287-2025 | — | open, classified | Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field. |
| Mar 31, 2016 | Z-1789-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1731-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1761-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1754-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1795-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1728-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1776-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1751-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1764-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1757-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1811-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1803-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1763-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1780-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1739-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1753-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1765-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1779-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1732-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1730-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1749-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1782-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1721-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1777-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1796-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1727-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1785-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1758-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1747-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1786-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1726-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1724-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1772-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1787-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1793-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1768-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1775-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1790-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1760-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1755-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1778-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1774-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1759-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1788-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1797-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1735-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1767-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1805-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1762-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1792-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1733-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1807-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1736-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1771-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1722-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1794-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1804-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1798-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1750-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1723-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1748-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1773-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1746-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1808-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1743-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1800-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1781-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1745-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1801-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1744-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1737-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1769-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1783-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1742-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1725-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1752-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1756-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1784-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1806-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1809-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1741-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1770-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1810-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1729-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1766-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1799-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1738-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1802-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1740-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1734-2016 | — | terminated | Product packaging defective compromising sterility |
| Mar 31, 2016 | Z-1791-2016 | — | terminated | Product packaging defective compromising sterility |