Light, Surgical Headlight

Product Code: EBA

Dental 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: 872.4630


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as EBA

1117Light, Surgical HeadlightDental Operating Light.

Total Product Life Cycle (TPLC) Devices

1117Light, Surgical HeadlightDental Operating Light.

Pre-market Notifications for EBA

K070287PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500PHOTONIC OPTISCHE GERATE GMBH & COKG
K893458FIBEROPTIC HEADLIGHT SYSTEMCUDA PRODUCTS CO.
K854646VEGA DENTAL OPERATING LIGHTALPINE DENTAL EQUIPMENT CO.
K842358ISOLIGHTPLANMECA USA, INC.
K842515SURGICAL HEADLIGHTGOOD-LITE CO.
K822265FIBEROPTIC LIGHT SOURCE W/RELATED ITEMSKELLEHER CORP.
K810117HALOGEN HEADLIGHT SYSTEMCOLMED, LTD.
K790807METALITHARRY J. BOSWORTH CO.
K790806PORCELITHARRY J. BOSWORTH CO.

Global Unique Device Identification Database

10614950000071LIGHT, SURGICAL HEADLIGHT
00821925026506LIGHT, SURGICAL HEADLIGHT
00766054002857LIGHT, SURGICAL HEADLIGHT
00860179001020Light, Surgical Headlight
14026704737168LIGHT, SURGICAL HEADLIGHT
10885403067884LIGHT, SURGICAL HEADLIGHT
10885403067877LIGHT, SURGICAL HEADLIGHT
B089B785730LIGHT, SURGICAL HEADLIGHT
B089B785720LIGHT, SURGICAL HEADLIGHT
B089B785710LIGHT, SURGICAL HEADLIGHT
B089B785700LIGHT, SURGICAL HEADLIGHT
B089B785490LIGHT, SURGICAL HEADLIGHT
B089B785480LIGHT, SURGICAL HEADLIGHT
B089B785470LIGHT, SURGICAL HEADLIGHT
B089B785460LIGHT, SURGICAL HEADLIGHT

Maude Adverse Events

LOUPEMETREX RESEARCH LLC DBA ORASCOPTIC, SURGICAL ACUIT2019-08-23
SURGILUX H/L VAR.10-75MM SPOT 8' XLGTELEFLEX MEDICAL2019-04-18
lITHONIA LIGHTING FROM INTEGRASEALLITHONIA LIGHTING/ACUITY BRANDS LIGHTING2019-01-29
LITHONIA LIGHTING FROM INTEGRASEAL SURGERY LIGHT FIXTUREINTEGRASEAL/ACUITY LIGHTING GROUP, INC.2019-01-29
LITHONIA LIGHTING FROM INTEGRASEAL SURGERY LIGHT FIXTUREINTEGRASEAL/ACUITY LIGHTING GROUP, INC.2019-01-29
SKYTRONDKK2015-09-03
SKYTRONDAI-ICHI SHOMEI2015-07-21
SKYTRONMICROTEK2015-06-29
SKYTRONDKK2015-02-12
ZEON DISCOVERYKERR CORPORATION2014-09-16
ZEON APOLLOKERR CORPORATION2014-04-15
ZEON APOLLOKERR CORPORATION2014-03-07
ZEON DISCOVERYKERR CORPORATION2014-02-12
XENON 300 HEADLIGHT BOXUNK2014-01-30
ZEON APOLLOKERR CORPORATION2012-07-12
PILLING HEAD LAMP CABLETELEFLEX MEDICAL2008-10-16
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.