Lamp, Operating-room

Product Code: FQP

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 FQP

5508Lamp, Operating-roomSurgical Lamp.

Total Product Life Cycle (TPLC) Devices

5508Lamp, Operating-roomSurgical Lamp.

Pre-market Notifications for FQP

K001223ACULUX, MODEL AX3001, AX3002ACULUX
K993314SYNTHES LIGHT GUIDESYNTHES (USA)
K781581SURGICAL LIGHT 22 SERIESAMERICAN STERILIZER CO.

Global Unique Device Identification Database

00815871022408Lamp, Operating-Room
00815871021906Lamp, Operating-Room
00815871021890Lamp, Operating-Room
00815871021487Lamp, Operating-Room
00815871021456Lamp, Operating-Room
00815871020756Lamp, Operating-Room
00815871020749Lamp, Operating-Room
00815871020732Lamp, Operating-Room
00815871020718Lamp, Operating-Room
00815871020701Lamp, Operating-Room
00815871020695Lamp, Operating-Room
00815871020688Lamp, Operating-Room
00815871020664Lamp, Operating-Room
00815871020657Lamp, Operating-Room
00815871020640Lamp, Operating-Room

Maude Adverse Events

SYNFRAME HALF RINGOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-18
SYNFRAME LENGTHENEROBERDORF SYNTHES PRODUKTIONS GMBH2020-03-16
SYNFRAME LENGTHENEROBERDORF SYNTHES PRODUKTIONS GMBH2020-03-16
SYNFRAME LENGTHENEROBERDORF SYNTHES PRODUKTIONS GMBH2020-02-07
SYNFRAME CONNECTING RODWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-06
HEADLIGHT VAR 10-75MM SPOT W/8' CABLETELEFLEX MEDICAL2019-08-06
SYNFRAME LENGTHENERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2018-10-17
TRULIGHT 5000/3000 DUOTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-10-09
TRULIGHT 5510TRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-10-04
TRULIGHT DUO TUSMTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-10-04
TRULIGHT 5510TRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-10-04
TRULIGHT 5510TRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-10-04
TRULIGHT 5320TRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-10-04
TRULIGHT 5320TRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-10-04
SYNFRAME HOLDING RING TWO-PIECEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2018-09-24
ILED TRIPLETRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-09-06
ILED 7TRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-07-19
ILED 5K / VIDIAPORT SINGLETRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-06-28
ILED 5K / ILED 3 / VIDIAPORT 2000TRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-06-28
ILED 3K / TRUVIDIA/VIDIAPORTTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-06-28
ILED 5K / VIDIAPORT 2000TRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-06-28
ILEDTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-06-27
ILEDTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-01-04
ILEDTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2018-01-04
ILEDTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2017-06-21
SYNFRAME ANGLED ROD HOLDERSYNTHES HAGENDORF2017-05-25
TRULIGHTTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2017-05-19
ILEDTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2017-02-17
TRUMPF MEDICAL TRULIGHTTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2017-02-06
ILEDTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2016-11-18
TRULIGHTTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2016-11-17
TRULIGHTTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2016-11-16
3611 LITE GLOVECOVIDIEN2016-09-19
SYNFRAME LENGTHENERSYNTHES HAGENDORF2015-12-07
3632 LITE SLEEVECOVIDIEN2015-10-24
3612 LITE GLOVE 2X80COVIDIEN2015-09-21
3613 LITE GLOVECOVIDIEN2015-04-21
CHROMOPHAREBERCHTOLD2014-10-08
3612 LITE GLOVECOVIDIEN2014-09-04
3612 LITE GLOVECOVIDIEN2014-08-19
3612 LITE GLOVECOVIDIEN2014-08-05
OUTPATIENT IIPHILIPS BURTON2014-02-27
MAQUETMAQUET SUZHOU CO. LTD2014-01-09
3612 LITE GLOVECOVIDIEN2013-12-18
AIM LED DOUBLE CEILINGPHILIPS BURTON2013-11-26
SKYTRON SURGICAL LIGHT MODEL ST2323SKYTRON2013-11-21
OPERATING ROOM LIGHTBERCHTOLD2013-10-07
3612 LITE GLOVECOVIDIEN2013-08-23
OUTPATIENT II SINGLE CEILINGPHILIPS BURTON2013-05-02
AIMLED SINGLE CEILINGPHILIPS BURTON2013-04-09

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