| 2024-05-09 |
Class II
|
Ongoing |
Z-3079-2024 |
Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, R… |
— |
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the devic… |
| 2024-05-09 |
Class II
|
Ongoing |
Z-3078-2024 |
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011L… |
— |
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the devic… |
| 2024-05-09 |
Class II
|
Ongoing |
Z-3077-2024 |
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 810… |
— |
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the devic… |
| 2024-05-09 |
Class II
|
Ongoing |
Z-3076-2024 |
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 818392301013… |
— |
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the devic… |
| 2024-05-09 |
Class II
|
Ongoing |
Z-3075-2024 |
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1… |
— |
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the devic… |
| 2024-05-09 |
Class II
|
Ongoing |
Z-3074-2024 |
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 18102… |
— |
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the devic… |