Data / Medical devices / Neurosurgical Paddie
Neurosurgical Paddie (HBA): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Neurosurgical Paddie (product code HBA, Class 2, 21 CFR 882.4700). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on November 20, 2020, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HBA
- Device class
- 2
- Regulation
- 882.4700
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Dominican Republic | 2 |
| Israel | 1 |
| China | 1 |
Makers of Neurosurgical Paddie
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 |
|---|---|---|---|---|---|---|---|---|
| American Surgical Company, LLC | Beverly, MA, United States | Manufacturer | 3 | March 27, 1991 | 0 | 2 | 0 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Manufacturer, Specification developer | 2 | November 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Euroband Bioline LTD. | INDUSTRIAL PARK EMEK HEFER Central, Israel | Specification developer | 1 | December 30, 1992 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | September 26, 2014 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 1 | August 28, 1992 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Mystic, CT, United States | Manufacturer | 1 | August 28, 1992 | 0 | 0 | 0 | api.fda.gov |
| Omt, LLC | Fort Lauderdale, FL, United States | Specification developer | 1 | June 3, 2002 | 0 | 0 | 0 | api.fda.gov |
| Allmed Medical Products Co., Ltd. | ZHIJIANG CITY Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carwild Corp. | New London, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medsorb Dominicana, S.A. | San Pedro De Macoris, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Watauga Opportunities, Inc. | Boone, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 20, 2020. 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.