Data / Medical devices / United States / Scanlan International, Inc.
Scanlan International, Inc.: FDA-registered device maker in Saint Paul, MN, United States, 1 510(k) clearance
Scanlan International, Inc. is registered with the FDA (registration 2126670) in Saint Paul, MN, United States. It lists 43 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 5, 1994. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2126670
- Address
- 1 Scanlan PLZ, Saint Paul, MN, United States, 55107
- Owner or operator
- SCANLAN INTERNATIONAL, INC. (2126670)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 12, 1977
- Registered through
- 2026
- Brand names listed
- A/C LOCATOR, A/V Fistula Retractor, Adson Retractor, Bailey Finochietto Titanium Pediatric Retractor, Bailey Pediatric Retractor, Bryant Mitral Hook, Chaux Valve Retractor, Cochran Pediatric Retractor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Chisel (Osteotome) | KDG | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Contractor, Surgical | FZR | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dilator, Vessel, Surgical | DWP | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator | HTE | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps | HTD | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hemostat, Surgical | EMD | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Microsurgical | GZX | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ligator, Hemorrhoidal | FHN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Loupe, Diagnostic/Surgical | FSP | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Marker, Cardiopulmonary Bypass (Vein Marker) | MAB | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Mirror, General & Plastic Surgery | FTX | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Saw | HSO | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Snare, Surgical | GAE | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Valvulotome | MGZ | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 5, 1994 | K945474 | SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER | GCJ | Substantially Equivalent | Scanlan Intl., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 19, 2007 | 37596 | Not yet classified | Terminated | SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Lot AZ115806. | Incorrectly assembled by manufacturer | accessdata.fda.gov |
| July 27, 2005 | 32790 | Not yet classified | Terminated | Scanlan Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled micro fine blades, 6-1/4'', 16 cm. Catalog Number 7007-449. | Some scissors purchased before May 1, 2005 may not perform properly. They may have a crack in the blade that could break. | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Vessel, Surgical
- All makers of Rongeur
- All makers of Instrument, Surgical, Non-Powered
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Holder, Needle, Gastroenterologic
- All makers of Instrument, Manual, Surgical, General Use
Updated April 3, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.