Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
Predicate lineage
K063587
Cited as predicate by: K182080
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
None in the loaded window.
Similar devices
- ActiFog™ MEDICAL ACTION INDUSTRIES INC.
- Anti-Fog Kit Batrik Medical Manufacturing Inc
- Anti-Fog w/ Pad XODUS MEDICAL, INC.
- Anti-Fog w/ Pad; Non Sterile XODUS MEDICAL, INC.
- Anti-Fog w/ Pad; PL XODUS MEDICAL, INC.
- Anti-Fog w/ Pad; in Tray XODUS MEDICAL, INC.
- Anti-Fog w/ Pad; in Tray XODUS MEDICAL, INC.
- Anti-fog w/Pad XODUS MEDICAL, INC.
- AntiFogOR THE O R COMPANY PTY LTD
- ArcRoyal Anti-Fog, Regular Solution, Sterile ASPEN SURGICAL PRODUCTS, INC.
- Aspen® Anti-fog Solution ASPEN SURGICAL PRODUCTS, INC.
- Aspen® Anti-fog Solution ASPEN SURGICAL PRODUCTS, INC.
Select up to two to place side-by-side with this device.