Sun Scientific, Inc.

FDA Regulatory Profile

Sun Scientific, Inc. appears in FDA public data with 0 recalls, 3 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Dec 17, 2024 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Sep 7, 2023.

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Summary

Total Recalls
0
510(k) Clearances
3
Inspections
3
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 17, 2024Dobbs Ferry, NYDevicesNo Action Indicated (NAI)3008773774
Oct 22, 2021Dobbs Ferry, NYDevicesVoluntary Action Indicated (VAI)3008773774
Jan 23, 2020Dobbs Ferry, NYDevicesNo Action Indicated (NAI)3008773774

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K222823AeroDVx Arm SystemSep 7, 2023
K183349AeroDVx SystemJul 19, 2019
K070457SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFABMay 16, 2007