Company ยท US
Pharmaceutical Innovations, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2018. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 2018 | K163027 | Ultra/Phonic Free Conductivity Gel Pharmaceutical Innovations, Inc. | MUI |
| Jan 9, 2018 | K163026 | Ultra/Phonic Scanning Gel Pharmaceutical Innovations, Inc. | MUI |
| Jan 8, 2018 | K163024 | Ultra/Phonic Conductivity Gel Pharmaceutical Innovations, Inc. | MUI |
| Jan 8, 2018 | K163023 | Other-Sonic Transmission Gel Pharmaceutical Innovations, Inc. | MUI |
| Jun 26, 1996 | K961222 | EVRON GEL Pharmaceutical Innovations, Inc. | KMJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2020 | Pharmaceutical Innovations, Inc. Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary pur Terminated |
MUI | None listed |
| Jun 19, 2019 | Pharmaceutical Innovations, Inc. Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution. Terminated |
GYB | None listed |
| Jun 19, 2019 | Pharmaceutical Innovations, Inc. ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution. Terminated |
GYB | None listed |
| Jun 19, 2019 | Pharmaceutical Innovations, Inc. ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution. Terminated |
GYB | None listed |
| Jun 19, 2019 | Pharmaceutical Innovations, Inc. ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution. Terminated |
GYB | None listed |
| Jun 19, 2019 | Pharmaceutical Innovations, Inc. Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution. Terminated |
GYB | None listed |
| May 24, 2012 | Pharmaceutical Innovations, Inc. Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic
Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the Terminated |
MUI | None listed |
| May 24, 2012 | Pharmaceutical Innovations, Inc. Other-Sonic Generic Ultrasound Transmission Gel 250 mL
Hypoallergenic
Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the tr Terminated |
MUI | None listed |