Light, Surgical, Accessories

Product Code: FTA

General & Plastic Surgery General Optical Products / Medical

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4580


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as FTA

5521Light, Surgical, AccessoriesSurgical Lamp.

Total Product Life Cycle (TPLC) Devices

5521Light, Surgical, AccessoriesSurgical Lamp.

Pre-market Notifications for FTA

K150532Universal Light Handle Cover, Light Handle CoverKey Surgical, Inc.
K142386Operating Room Light Handle AdapterLitex Manufacturing, Inc.
K133554SURGICAL LIGHT HANDLE COVERMICROTEK MEDICAL, INC. AN ECOLAB COMPANY
K133413IDSS SLCBLACK DIAMOND VIDEO
K112133OASYS SURGICAL LIGHT CONTROLLEROASYS HEALTHCARE
K102791EASYSUITE SURGICAL LIGHT CONTROL (ESLC)IMAGE STREAM MEDICAL, INC.
K081698MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)IMAGE STREAM MEDICAL, INC.
K053321LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERXODUS MEDICAL, INC.
K051505SCB/STERIS OR-LIGHT INTERFACE BOXKARL STORZ ENDOSCOPY-AMERICA, INC.
K023704KSEA SCB ACC CONTROLKARL STORZ ENDOSCOPY-AMERICA, INC.
K020640KSEA SCB MEDIA CONTROLKARL STORZ ENDOSCOPY-AMERICA, INC.
K020304DISPOSABLE LIGHT HANDLE AND ADAPTORASPEN SURGICAL PRODUCTS, INC.
K993089DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTERDEROYAL CARDIOVASCULAR, INC.
K954940MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLEMDT BIOLOGIC CO.
K935102SATURN LIGHTBURTON MEDICAL PRODUCTS CORP.

Global Unique Device Identification Database

50749756873111Light, surgical, accessories
50749756866823Light, surgical, accessories
30749756866812Light, surgical, accessories
30749756866805Light, surgical, accessories
50749756866793Light, surgical, accessories
50749756650804Light, surgical, accessories
50749756581719Light, surgical, accessories
50749756581702Light, surgical, accessories
50749756581696Light, surgical, accessories
50749756581689Light, surgical, accessories
50749756581672Light, surgical, accessories
50749756581665Light, surgical, accessories
50749756581658Light, surgical, accessories
50749756581641Light, surgical, accessories
50749756581634Light, surgical, accessories

Maude Adverse Events

ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2020-03-18
ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2020-02-17
ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2020-02-06
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-12-09
ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-11-25
ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-11-14
ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-11-14
ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-11-14
ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-11-14
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-10-14
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-09-17
SKYTRON RIGID LIGHT HANDLE ADAPTOR WITH PUSH BUTTONASPEN SURGICAL PRODUCTS, CALEDONIA2019-09-09
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-09-03
NALIGHT, SURGICAL, ACCESSORIESSTERIS CORPORATION2019-08-01
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-07-08
LOU TOTAL KNEE PACK LIGHT HANDLE COVERSMEDLINE2019-06-14
LOU MAJOR PROCEDURE LIGHT HANDLE COVERSMEDLINE INDUSTRIES, INC.2019-06-14
ASPEN FLEXIBLE UNBANDED LIGHT HANDLE COVER, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-06-13
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-04-16
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-03-20
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-03-12
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2019-01-25
ASPEN FLEXIBLE UNBANDED LIGHT HANDLE COVER, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-12-17
KEY SURGICAL UNIVERSAL LIGHT HANDLE COVERKEY SURGICAL LLC2018-12-14
KEY SURGICAL UNIVERSAL LIGHT HANDLE COVERKEY SURGICAL LLC2018-12-14
MEDLINE RIGID LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-12-03
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-11-12
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-11-06
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-10-30
RIGID ADAPTOR - STERIS (AMSCO) HARMONY (CENTER FOCUS / SWITCHING)ASPEN SURGICAL PRODUCTS, CALEDONIA2018-09-27
LIGHT HANDLE COVERBRENTWOOD INDUSTRIES, INC.2018-09-06
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-09-05
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-09-05
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-08-20
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-06-18
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-06-18
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-06-18
RIGID ADAPTOR - STERIS (AMSCO) HARMONY (CENTER FOCUS/SWITCHING)ASPEN SURGICAL PRODUCTS, CALEDONIA2018-06-01
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2018-02-28
CAMERA COVER ADAPTOR FOR STRYKER VISIUM LEDASPEN SURGICAL PRODUCTS, CALEDONIA2018-02-22
CAMERA COVER ADAPTOR FOR STRYKER VISIUM LEDASPEN SURGICAL PRODUCTS, CALEDONIA2018-02-21
CAMERA COVER ADAPTOR FOR STRYKER VISIUM LEDASPEN SURGICAL PRODUCTS, CALEDONIA2018-02-21
CAMERA COVER ADAPTOR FOR STRYKER VISIUM LEDASPEN SURGICAL PRODUCTS, CALEDONIA2018-02-21
FLEXIBLE LIGHT HANDLE COVERSDEROYAL INTERCONTINENTAL, S.R.L.2017-12-14
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2017-12-01
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILE (250/BOX)ASPEN SURGICAL PRODUCTS, CALEDONIA2017-11-22
FLEXIBLE LIGHT HANDLE COVERDEROYAL INTERCONTINENTAL, S.R.L.2017-11-10
ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2017-11-04
MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILEASPEN SURGICAL PRODUCTS, CALEDONIA2017-10-18
SURGICLICKDEROYAL INDUSTRIES, INC.2017-10-02
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