Light, Surgical, Ceiling Mounted

Product Code: FSY

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 FSY

5519Light, Surgical, Ceiling MountedSurgical Lamp.

Total Product Life Cycle (TPLC) Devices

5519Light, Surgical, Ceiling MountedSurgical Lamp.

Pre-market Notifications for FSY

K142984Leo MinorSUNNEX, INC.
K142076CLAVEGUARD FREEDOM SURGICAL LIGHTDICKSON & DICKSON HEALTHCARE (US), INC
K140930VIDA LED SURGICAL LIGHTING SYSTEM, V SERIESCONVIDA HEALTHCARE & SYSTEMS CORPORATION
K140812MI-750 PROCEDURAL/MINOR SURGICAL LIGHTMEDICAL ILLUMINATION INTERNATIONAL, INC.
K140461MACH LED 2MCDR. MACH GMBH & CO. KG
K140460MACH LED 2SCDR. MACH GMBH & CO. KG
K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMSTRYKER COMMUNICATIONS
K132551ZF 720UMBEL CORPORATION
K132307VIDA LED SURGICAL LIGHTING SYSTEMCONVIDA HEALTHCARE & SYSTEMS CORPORATION
K131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAJW TECHNOLOGY CONSULTANTS, INC.
K122875ORICARE L2700ORICARE, INC.
K120392CHROMOPHARE F 628 AND F 528BERCHTOLD GMBH & CO. KG
K102758TRULIGHT 5520 AND TRULIGHT 5320TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG
K101537AIM 200, MAJOR SURGICAL LIGHTBURTON MEDICAL PRODUCTS CORP.
K100702STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODSHUOT INSTRUMENTS, LLC

Global Unique Device Identification Database

00684706000825Light, Surgical, Ceiling Mounted
00684706000818Light, Surgical, Ceiling Mounted
00684706000801Light, Surgical, Ceiling Mounted
00684706000795Light, Surgical, Ceiling Mounted
00684706000788Light, Surgical, Ceiling Mounted
00684706000771Light, Surgical, Ceiling Mounted
00684706000764Light, Surgical, Ceiling Mounted
00684706000757Light, Surgical, Ceiling Mounted
00684706000740Light, Surgical, Ceiling Mounted
00684706000733Light, Surgical, Ceiling Mounted
00684706000726Light, Surgical, Ceiling Mounted
00684706000719Light, Surgical, Ceiling Mounted
00684706000702Light, Surgical, Ceiling Mounted
00684706000696Light, Surgical, Ceiling Mounted
00684706000689Light, Surgical, Ceiling Mounted

Maude Adverse Events

POWERLEDMAQUET SAS2020-03-31
ILED DUOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-25
ILED DUOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-25
ILED DUOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-25
ILED DUOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-25
ILED DUOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-25
ILED DUOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-25
ILED DUOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-25
ILED DUOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-25
ILED DUOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-17
TRULIGHT SINGLE TUSMTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-16
MODUTECMAQUET SAS2020-03-16
MODUTECMAQUET SAS2020-03-16
CHROMOPHARE OR LIGHT CEILING-MOUNTEDBERCHTOLD GMBH & CO. KG2020-03-13
POWERLEDMAQUET SAS2020-03-12
POWERLEDMAQUET SAS2020-03-11
POWERLEDMAQUET SAS2020-03-11
POWERLEDMAQUET SAS2020-03-11
POWERLEDMAQUET SAS2020-03-11
POWERLEDMAQUET SAS2020-03-11
POWERLEDMAQUET SAS2020-03-11
POWERLEDMAQUET SAS2020-03-11
POWERLEDMAQUET SAS2020-03-11
TRULIGHT TRIBLE TUSMTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-10
TRULIGHT TRIBLE TUSMTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-10
TRULIGHT TRIBLE TUSMTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-10
TRULIGHT TRIBLE TUSMTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-06
TRULIGHT TRIBLE TUSMTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-06
ILED DUOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-03-06
FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KGSTRYKER-COMMUNICATIONS2020-03-03
POWERLEDMAQUET SAS2020-03-03
POWERLEDMAQUET SAS2020-03-02
HARMONYAIR M SERIES SURGICAL LIGHTING SYSTEMSTERIS CORPORATION - MONTGOMERY2020-02-28
POWERLEDMAQUET SAS2020-02-24
BLUELINEMAQUET SAS2020-02-24
BLUELINEMAQUET SAS2020-02-21
ILED 7 TRIOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-02-21
VOLISTA STANDOPMAQUET SAS2020-02-19
VOLISTA STANDOPMAQUET SAS2020-02-19
VOLISTA STANDOPMAQUET SAS2020-02-19
VOLISTA STANDOPMAQUET SAS2020-02-19
VOLISTA STANDOPMAQUET SAS2020-02-19
HANAULUXMAQUET SAS2020-02-18
POWERLEDMAQUET SAS2020-02-18
SURGICAL LIGHTMAQUET SAS2020-02-18
POWERLEDMAQUET SAS2020-02-18
POWERLEDMAQUET SAS2020-02-14
3631 LITE SLEEVECOVIDIEN2020-02-13
3631 LITE SLEEVECOVIDIEN2020-02-13
ILED 7 TRIOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-02-13

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