Pharmaceutical Innovations, Inc.

FDA Regulatory Profile

Pharmaceutical Innovations, Inc. appears in FDA public data with 6 recalls, 5 510(k) clearances, 5 FDA inspections, and 3 compliance actions on record. Its most recent recall (Z-2830-2020, Class II) was initiated on August 13, 2020. Its most recent 510(k) clearance was granted on January 9, 2018.

Summary

Total Recalls
6
510(k) Clearances
5
Inspections
5
Compliance Actions
3

Recent Recalls

NumberClassProductDate
Z-2830-2020Class IIUltra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - August 13, 2020
Z-1969-2019Class IIElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.June 19, 2019
Z-1972-2019Class IIAlpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray June 19, 2019
Z-1971-2019Class IIElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.June 19, 2019
Z-1970-2019Class IIElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.June 19, 2019
Z-1968-2019Class IIAlpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray soJune 19, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K163027Ultra/Phonic Free Conductivity GelJanuary 9, 2018
K163026Ultra/Phonic Scanning GelJanuary 9, 2018
K163024Ultra/Phonic Conductivity GelJanuary 8, 2018
K163023Other-Sonic Transmission GelJanuary 8, 2018
K961222EVRON GELJune 26, 1996