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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

DeviceProduct codeClassRoleSource
Cannula, Surgical, General & Plastic SurgeryGEA1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Chisel (Osteotome)KDG1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Manufacturer, Specification developeraccessdata.fda.gov
Clamp, VascularDXC2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Contractor, SurgicalFZR1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
CuretteHTF1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Cutter, SurgicalFZT1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Cutter, WireHXZ1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Dilator, Vessel, SurgicalDWP2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
ElevatorHTE1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
ForcepsHTD1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Hemostat, SurgicalEMD1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Manufacturer, Specification developeraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Knife, SurgicalEMF1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Manufacturer, Specification developeraccessdata.fda.gov
Loupe, Diagnostic/SurgicalFSP1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Marker, Cardiopulmonary Bypass (Vein Marker)MAB2Manufacturer, Specification developeraccessdata.fda.gov
Marker, SkinFZZ1Manufacturer, Specification developeraccessdata.fda.gov
Mirror, General & Plastic SurgeryFTX1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
RaspHTR1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
RetractorGAD1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
RongeurHTX1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
SawHSO1Manufacturer, Specification developeraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Snare, SurgicalGAE1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Speculum, EntEPY1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
ValvulotomeMGZ2Manufacturer, Repackager or relabeler, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 5, 1994K945474SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDERGCJSubstantially EquivalentScanlan Intl., Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
February 19, 200737596Not yet classifiedTerminatedSCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Lot AZ115806.Incorrectly assembled by manufactureraccessdata.fda.gov
July 27, 200532790Not yet classifiedTerminatedScanlan 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

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.