Company ยท US
Insight Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2005. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2013 | Insight Instruments, Inc. MLS Torpedo Mini-Light Ophthalmic single-port illumination.
Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired. Terminated |
HNJ | None listed |
| May 10, 2013 | Insight Instruments, Inc. Insight Instruments MIS ( Multi-Port Illumination System)
Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the m Terminated |
HMX | None listed |
| Aug 13, 2010 | Insight Instruments, Inc. BIOM PACK, Contents Individually Sterile. QTY 5 EA. Each Pack Contains: 1 EA. Microscope Drape (REF40100), 1 EA. Cornea Coat (REF 60010), 1 EA. SuperView BIOM Lens Set (REF 40411).
Manufactured Terminated |
KYG | None listed |
| Aug 13, 2010 | Insight Instruments, Inc. CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY.
Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA.
REF 60010.000, QTY 14 - This pa Terminated |
KYG | None listed |