Data / Medical devices / Needle, Spinal, Short Term
Needle, Spinal, Short Term (MIA): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make Needle, Spinal, Short Term (product code MIA, Class 2, 21 CFR 868.5150). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on June 14, 2018, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MIA
- Device class
- 2
- Regulation
- 868.5150
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Japan | 2 |
| South Korea | 2 |
| Mexico | 1 |
| Honduras | 1 |
Makers of Needle, Spinal, Short Term
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 2 | June 14, 2018 | 0 | 0 | 0 | api.fda.gov |
| Unisis Corp | Kita-Hiroshima-shi Hokkaido, Japan | Contract manufacturer, Manufacturer | 2 | June 14, 2018 | 0 | 0 | 0 | api.fda.gov |
| Epimed International, Inc. | Johnstown, NY, United States | Manufacturer | 1 | August 22, 2005 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Contract manufacturer, Manufacturer | 1 | January 29, 1999 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 1 | December 5, 1994 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 1 | December 5, 1994 | 0 | 0 | 0 | api.fda.gov |
| Spectra Medical Devices, LLC | Wilmington, MA, United States | Manufacturer | 1 | August 1, 1997 | 0 | 0 | 0 | api.fda.gov |
| Custom Tube Manufacturing LLC | Yangju-si Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tae-Chang Industrial Co., Ltd. | Gongju-si Chungnam, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unisis Corp. | Koshigaya-shi Saitama, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 14, 2018. 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.