Data / Medical devices / United States / Aspen Surgical Products, Inc.

Aspen Surgical Products, Inc.: FDA-registered device maker in Caledonia, MI, United States, 143 510(k) clearances

Aspen Surgical Products, Inc. is registered with the FDA (registration 1836161) in Caledonia, MI, United States. It lists 655 device types. The FDA files 143 510(k) clearances under its listings, the newest dated January 22, 2019. 8 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number

1836161

FEI number

3002750084

Address

6945 Southbelt DR. S.E., Caledonia, MI, United States, 49316

Owner or operator

Aspen Surgical Products (10061390)

Roles

Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer

First device listed

October 14, 2019

Registered through

2027

Brand names listed

ALC Plus Disposable Light Handle Cover, AMNIHOOK AMNIOTIC MEMBRANE PERFORATOR, Adaptors, Aspen, Aspen Basin, Aspen Needle Container, Aspen Needle Counter, Bard-Parker and more

Devices it lists

255 more device types in the FDA listing

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. Newest 100 of 143.

Recalls

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

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Updated June 27, 2024. 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.