Light, Surgical, Floor Standing

Product Code: FSS

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 FSS

5515Light, Surgical, Floor StandingSurgical Lamp.

Total Product Life Cycle (TPLC) Devices

5515Light, Surgical, Floor StandingSurgical Lamp.

Pre-market Notifications for FSS

K091246ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
K003489NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8MEDICAL ILLUMINATION INTERNATIONAL, INC.
K984124AESCULAP XENON LIGHT SOURCEAESCULAP, INC.
K981962CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCECUDA PRODUCTS CO.
K981821VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORANGIOLAZ, INC.
K981469CERMAX300 LIGHTSOURCECUDA PRODUCTS CO.
K980044XENON 300MXPERKINELMER OPTOELECTRONICS
K970886HANAULUX BLUE 80 HOSPITALHERAEUS MED GMBH
K961971Q-5000Stryker Endoscopy
K961074LIGHTSOURCE OR ILLUMINATORCUDA PRODUCTS CO.
K930711TRI*STARLIGHT TECHNOLOGY SYSTEMS
K910942AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHTMDT BIOLOGIC CO.
K895950MODEL FEL5100 FLOOR LIGHTF.W. LANG CO.
K893813FLOOR STANDING, OPERATING AND EXAMINING LIGHTASTRALITE CORP.
K891758KINETIC MODEL 132KINETIC BIOMEDICAL SERVICES, INC.

Global Unique Device Identification Database

00724995150303Light, surgical, floor standing
00724995150297Light, surgical, floor standing
00811889031319Light, Surgical, Floor Standing
00811889031302Light, Surgical, Floor Standing
00811889031296Light, Surgical, Floor Standing
00811889031289Light, Surgical, Floor Standing
00815871020725Light, Surgical, Floor Standing
00815871020671Light, Surgical, Floor Standing
00815871020602Light, Surgical, Floor Standing
00815871020510Light, Surgical, Floor Standing
00815871020497Light, Surgical, Floor Standing
00860292000306Light, Surgical, Floor Standing
07613327296228Light, surgical, floor standing
04046963903848Light, surgical, floor standing
04046963730109Light, surgical, floor standing

Maude Adverse Events

LIGHTCABLE DIAM.4.8 LENGTH:2,5MAESCULAP AG2020-02-26
TRULIGHT MOBILETRUMPF MEDIZIN SYSTEME GMBH + CO. KG2020-02-13
LUCEAMAQUET SAS2020-01-28
BLUE 80MAQUET SAS2019-12-05
BLUELINEMAQUET SAS2019-09-23
LUCEA 40 MOBILEMAQUET S.A.S.2019-08-05
LUCEA 40 MOBILEMAQUET S.A.S.2019-08-05
LUCEA 40 MOBILEMAQUET S.A.S.2019-08-05
LUCEA 40 MOBILEMAQUET S.A.S.2019-08-05
LUCEA 40 MOBILEMAQUET S.A.S.2019-08-05
LUCEA 40 MOBILEMAQUET S.A.S.2019-08-05
LUCEA 40 MOBILEMAQUET S.A.S.2019-08-05
LUCEA LED 40 MOBILEMAQUET S.A.S.2019-08-05
LIGHT SOURCE, 500XL, XENONSMITH & NEPHEW, INC.2017-07-31
VOLISTAMAQUET SAS2017-06-19
TRULIGHTTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2016-12-20
HARMONY LEDSTERIS CORPORATION2016-10-31
AXEL XENON LIGHT SOURCE 180WAESCULAP AG2015-11-18
TRULIGHTTRUMPF MEDIZIN SYSTEME GMBH + CO. KG2015-11-11
LUCEA LEDMAQUET SAS2015-10-21
UNKNOWN_ENDOSCOPY_PRODUCTSTRYKER ENDOSCOPY-SAN JOSE2015-07-28
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2015-06-11
L9000 LIGHT SOURCESTRYKER ENDOSCOPY-SAN JOSE2015-04-10
X8000 LIGHTSOURCESTRYKER ENDOSCOPY-SAN JOSE2015-04-10
UNKNOWN_ENDOSCOPY_PRODUCTSTRYKER ENDOSCOPY-SAN JOSE2015-03-20
UNKNOWN_ENDOSCOPY_PRODUCTSTRYKER ENDOSCOPY-SAN JOSE2015-03-13
UNKNOWN_ENDOSCOPY_PRODUCTSTRYKER ENDOSCOPY-SAN JOSE2015-03-03
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2014-12-19
X8000 LIGHTSOURCESTRYKER ENDOSCOPY-SAN JOSE2014-12-19
BLUE 30MAQUET SAS2014-10-14
PKG,FIBEROPTIC UNIVERSAL 5MM X 10FT (3.05M)STRYKER ENDOSCOPY-SAN JOSE2014-09-29
X7000 XENON LIGHTSOURCESTRYKER ENDOSCOPY-SAN JOSE2014-08-05
HANAULUX 3000MAQUET S.A.S2014-07-25
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2014-06-20
BLUE 30MAQUET S.A.S.2014-06-04
5.0MM X 10FT FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2014-05-06
5.0MM X 7.5FT NON-TRANSPARENT FIBEROPTIC CABLESTRYKER ENDOSCOPY-SAN JOSE2014-04-07
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2014-03-18
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2014-02-24
X8000 LIGHTSOURCESTRYKER ENDOSCOPY-SAN JOSE2014-01-31
BLUE 30MAQUET SAS2014-01-17
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2013-12-03
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2013-12-03
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2013-11-12
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2013-10-22
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2013-07-01
X8000 LIGHTSOURCESTRYKER ENDOSCOPY-SAN JOSE2013-06-03
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2013-06-03
X7000 XENON LIGHTSOURCESTRYKER ENDOSCOPY-SAN JOSE2013-03-28
5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLESTRYKER ENDOSCOPY-SAN JOSE2013-03-08

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