Company ยท US
Aaren Scientific, Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2013. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2017 | Aaren Scientific Inc. AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontario, CA.
Used to fold and insert the fir Terminated |
MSS | K123888 |
| Mar 20, 2015 | Aaren Scientific, Incorporated Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0.
The device is indicated for primary implantation in the capsular bag of the Terminated |
HQL | None listed |
| Feb 22, 2012 | Aaren Scientific, Incorporated UV-Absorbing Posterior Chamber IOL
Model: SP-65A2,
Serial Number:
1168471106, 1168481106, 1168491106, 1168501106, 1168511106, 1168521106, 1168531106, 1168541106, 1168551106, 1168561106, 1168571106, Terminated |
HQL | None listed |
| Feb 22, 2012 | Aaren Scientific, Incorporated UV-Absorbing Posterior Chamber IOL
Model: RS-55B,
Serial Number:
1167121106, 1167131106, 1167141106, 1167151106, 1167161106, 1167171106, 1167181106, 1167191106, 1167201106, 1167211106, 1167221106, 11 Terminated |
HQL | None listed |
| Feb 22, 2012 | Aaren Scientific, Incorporated Precision Aspheric Lens (PAL) Intraocular Lens
Model: EC-3 PAL,
Serial Number: 1169381106, 1169391106, 1169421106
The device is indicated for primary implantation in the capsular bag of the eye for t Terminated |
HQL | None listed |
| Feb 22, 2012 | Aaren Scientific, Incorporated Intraocular Lens (IOL).
Model: EC-3,
Serial Number: 1169371106, 1169401106, 1169471106
The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aph Terminated |
HQL | None listed |