Pharmaceutical Innovations, Inc.
Medical device manufacturer in Newark, NJ.
5510(k) clearances
0PMA approvals
8recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K163027 | Ultra/Phonic Free Conductivity GelMUI · Traditional | 01/09/2018SE |
| K163026 | Ultra/Phonic Scanning GelMUI · Traditional | 01/09/2018SE |
| K163024 | Ultra/Phonic Conductivity GelMUI · Traditional | 01/08/2018SE |
| K163023 | Other-Sonic Transmission GelMUI · Traditional | 01/08/2018SE |
| K961222 | Evron GelKMJ · Traditional | 06/26/1996SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2830-2020 Class II | Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028…The firm registered the product as a Class I device, but has since been informed by FDA that the device is… | 08/13/2020Terminated |
| Z-1972-2019 Class II | Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode…Potential for failed stability antimicrobial effectiveness testing. | 06/19/2019Terminated |
| Z-1971-2019 Class II | ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray…Potential for failed stability antimicrobial effectiveness testing. | 06/19/2019Terminated |
| Z-1970-2019 Class II | ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray…Potential for failed stability antimicrobial effectiveness testing. | 06/19/2019Terminated |
| Z-1969-2019 Class II | ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray…Potential for failed stability antimicrobial effectiveness testing. | 06/19/2019Terminated |
| Z-1968-2019 Class II | Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode…Potential for failed stability antimicrobial effectiveness testing. | 06/19/2019Terminated |
| Z-1653-2012 | Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is…Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination.… | 03/02/2012Terminated |
| Z-1652-2012 | Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a…Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination.… | 03/02/2012Terminated |