Home › Paragon 28, Inc. › Monster Screw System
Monster Screw System
Paragon 28, Inc. · Model P99-998-0014 · UDI-DI 00889795041647
GAH
Prescription
7
510(k) clearances
37
Adverse events
3
Recalls
97
Facilities
Description
Cannulated Cleaning Stylet, 1.4mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-01 | CLINICAL LASERTHERMIA SYSTEMS AB | single use devices labeled as sterile may not have been adequately sterilized |
| 2016-09-01 | Medtronic Navigation, Inc. | Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is plac |
| 2016-09-01 | Medtronic Navigation, Inc. | Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is plac |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.