Panels › General, Plastic Surgery › Product code FTA · Class 2
Light, Surgical, Accessories
Regulation 878.4580
0510(k)s in 12 months (26 all time)
1recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in FTA
| Company | 510(k)s | Recalls |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 3 | 0 |
| Steris Corporation | 0 | 3 |
| Image Stream Medical, Inc. | 2 | 0 |
| Sunnex Inc. | 0 | 2 |
| Transmedical Corp. | 2 | 0 |
| American Medical Mfg., Inc. | 1 | 0 |
| Aspen Surgical Products, Inc. | 1 | 0 |
| Black Diamond Video | 1 | 0 |
| Burton Medical Products Corp. | 1 | 0 |
| Cavitron Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2026 | Steris Corporation HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18 Open, Classified |
FTA | None listed |
| Apr 28, 2023 | Steris Corporation Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for th Open, Classified |
FTA | None listed |
| Apr 28, 2023 | Steris Corporation Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light ha Open, Classified |
FTA | None listed |
| Oct 13, 2017 | Ecolab, Inc. Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a Terminated |
FTA | None listed |
| Jul 24, 2007 | Sunnex Inc. Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (mobile) , TS2015W (wall mount) , TS2035M (mobile) Terminated |
FTA | K930711 |
| Jul 24, 2007 | Sunnex Inc. Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model Numbers: CS2050C (ceiling mount), CS2050W (wall mount). CS2050D (dual mount) , CS2050M (mobile). Terminated |
FTA | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.