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
- 510(k)K133425Substantially equivalent (SESE) · 2013-12-05clearance family
Predicate lineage
- K133425
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
- A-dec A-DEC, INC.
- Alite Revelle Aesthetics, Inc.
- Aveli Revelle Aesthetics, Inc.
- Aveli Revelle Aesthetics, Inc.
- BURKHART DENTAL NORDENT MANUFACTURING INC
- BURKHART DENTAL NORDENT MANUFACTURING INC
- BURKHART DENTAL NORDENT MANUFACTURING INC
- BURKHART DENTAL NORDENT MANUFACTURING INC
- Beamer QED, INC.
- Dissector ATRICURE, INC.
- Dissector ATRICURE, INC.
- Dissector ATRICURE, INC.
Select up to two to place side-by-side with this device.