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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 2015 | K150532 | Universal Light Handle Cover, Light Handle Cover Key Surgical, Inc. | FTA |
| Sep 29, 2014 | K142386 | Operating Room Light Handle Adapter Litex Manufacturing, Inc. | FTA |
| Apr 8, 2014 | K133554 | SURGICAL LIGHT HANDLE COVER Microtek Medical, Inc. an Ecolab Company | FTA |
| Jan 7, 2014 | K133413 | IDSS SLC Black Diamond Video | FTA |
| Mar 1, 2012 | K112133 | OASYS SURGICAL LIGHT CONTROLLER Oasys Healthcare | FTA |
| Nov 23, 2010 | K102791 | EASYSUITE SURGICAL LIGHT CONTROL (ESLC) Image Stream Medical, Inc. | FTA |
| Jul 30, 2008 | K081698 | MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) Image Stream Medical, Inc. | FTA |
| Jan 19, 2006 | K053321 | LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER Xodus Medical, Inc. | FTA |
| Aug 11, 2005 | K051505 | SCB/STERIS OR-LIGHT INTERFACE BOX KARL STORZ Endoscopy-America, Inc. | FTA |
| Jan 30, 2003 | K023704 | KSEA SCB ACC CONTROL KARL STORZ Endoscopy-America, Inc. | FTA |
| May 28, 2002 | K020640 | KSEA SCB MEDIA CONTROL KARL STORZ Endoscopy-America, Inc. | FTA |
| Feb 14, 2002 | K020304 | DISPOSABLE LIGHT HANDLE AND ADAPTOR Aspen Surgical Products, Inc. | FTA |
| Oct 14, 1999 | K993089 | DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER Deroyal Cardiovascular, Inc. | FTA |
| Jan 17, 1996 | K954940 | MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE Mdt Biologic Co. | FTA |
| Jun 27, 1994 | K935102 | SATURN LIGHT Burton Medical Products Corp. | FTA |
| Feb 6, 1992 | K915068 | PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER American Medical Mfg., Inc. | FTA |
| Mar 20, 1990 | K901154 | MICROTEK'S SURGICAL LAMP HANDLE & COVER Microbio-Medics, Inc. | FTA |
| Aug 10, 1989 | K894397 | WELCON LIGHT HANDLE Welcon, Inc. | FTA |
| Mar 14, 1989 | K890867 | TC SYSTEM-COVER Transmedical Corp. | FTA |
| Mar 14, 1989 | K890866 | TC SYSTEM-HANDLE Transmedical Corp. | FTA |
| Feb 27, 1989 | K890539 | SURE COUNT LIGHT HANDLE COVER Kleen Test Products | FTA |
| Jun 15, 1988 | K882132 | LIGHT, SURGICAL ACCESSORIES Charles Polo & Co., Inc. | FTA |
| Apr 10, 1987 | K871034 | LCA 2000 Vistek Corp. | FTA |
| Jun 9, 1986 | K862010 | CHICK SURGICAL LIGHT Professional Medical Products, Inc. | FTA |
| Mar 4, 1981 | K810292 | CAM-WRAP Medline Industries, Inc. | FTA |
| Mar 27, 1978 | K780162 | DIGAPHOT PHOTOTHERAPY METER MODEL PT 145 Cavitron Corp. | FTA |
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