Insight Instruments, Inc.
Medical device manufacturer in Stuart, FL.
1510(k) clearances
0PMA approvals
4recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K051630 | Super View Disposable Biom Lens SetHJK · Traditional | 06/29/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0144-2014 Class II | MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge…The product was registered and distributed as a Class I medical device and was subsequently determined to be… | 06/27/2013Terminated |
| Z-1281-2013 Class II | Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work…Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic… | 03/15/2013Terminated |
| Z-2221-2010 | BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope…Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in… | 05/12/2010Terminated |
| Z-2220-2010 | CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. Manufactured…Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in… | 05/12/2010Terminated |