Data / Medical devices / Tray, Surgical, Needle
Tray, Surgical, Needle (FSH): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make Tray, Surgical, Needle (product code FSH, Class 1, 21 CFR 878.4800). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on December 15, 1988, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- FSH
- Device class
- 1
- Regulation
- 878.4800
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Mexico | 1 |
| Pakistan | 1 |
| Dominican Republic | 1 |
| China | 1 |
Makers of Tray, Surgical, Needle
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 |
|---|---|---|---|---|---|---|---|---|
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Specification developer | 1 | January 28, 1982 | 0 | 0 | 0 | api.fda.gov |
| Carefusion 2200, Inc. | Vernon Hills, IL, United States | Complaint file establishment, Specification developer | 1 | January 28, 1982 | 0 | 1 | 0 | api.fda.gov |
| Bard Reynosa S.A. De C.V. | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carefusion 2200, Inc. | Mannford, OK, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Surgical Instruments | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CareFusion D.R. 203 Ltd. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Shin Yi Healthcare Products Factory | DONG GUAN CITY Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mci Medical Concept Innovation Inc. | Sunrise, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ORIGAMI SURGICAL Inc. | Dover, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Palix Medical, LLC | Keyport, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterizign Precision Technologies | Brunswick, ME, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 15, 1988. 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.