Pharmaceutical Innovations, Inc.
Newark, NJ, US
Pharmaceutical Innovations, Inc. appears in FDA device records in Newark, NJ. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 8 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Pharmaceutical Innovations, Inc. between 1996 and 2018. The busiest year on record is 2018, with 4. The most recent is 2018, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 2018 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163027 | Ultra/Phonic Free Conductivity Gel | MUI | Substantially Equivalent | |
| K163026 | Ultra/Phonic Scanning Gel | MUI | Substantially Equivalent | |
| K163024 | Ultra/Phonic Conductivity Gel | MUI | Substantially Equivalent | |
| K163023 | Other-Sonic Transmission Gel | MUI | Substantially Equivalent | |
| K961222 | EVRON GEL | KMJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2830-2020 | 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 purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify. | The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission. | Class II | Terminated | |
| Z-1972-2019 | Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution. | Potential for failed stability antimicrobial effectiveness testing. | Class II | Terminated | |
| Z-1971-2019 | ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution. | Potential for failed stability antimicrobial effectiveness testing. | Class II | Terminated | |
| Z-1970-2019 | ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution. | Potential for failed stability antimicrobial effectiveness testing. | Class II | Terminated | |
| Z-1969-2019 | ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution. | Potential for failed stability antimicrobial effectiveness testing. | Class II | Terminated | |
| Z-1968-2019 | Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution. | Potential for failed stability antimicrobial effectiveness testing. | Class II | Terminated | |
| Z-1653-2012 | 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 transducer to the body. | Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012. | Terminated | ||
| Z-1652-2012 | 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 transducer to the body. | Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Pharmaceutical Innovations, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain