Light, Headband, Surgical

Product Code: FSR

Ophthalmic 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: 886.4335


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as FSR

4135Light, Headband, SurgicalOperating Headlamp.

Total Product Life Cycle (TPLC) Devices

4135Light, Headband, SurgicalOperating Headlamp.

Pre-market Notifications for FSR

K110528INTEGRA LED SURGICAL HEADLIGHT SYSTEMINTEGRA LIFE SCIENCES CORPORATION
K031548LED HEADLIGHTWELCH ALLYN, INC.
K031549SOLID STATE LAMP [LED] HEADLIGHTWELCH ALLYN, INC.
K994362HEADLAMP HL2000.ANGIOLAZ, INC.

Global Unique Device Identification Database

00732094073300Light, headband, surgical
00732094073089Light, headband, surgical
00732094073072Light, headband, surgical
00732094073065Light, headband, surgical
00732094072198Light, headband, surgical
00732094072174Light, headband, surgical
00732094072167Light, headband, surgical
00732094072150Light, headband, surgical
00732094072143Light, headband, surgical
00732094071818Light, headband, surgical
00732094041835Light, headband, surgical
00732094002591Light, headband, surgical
00732094002492Light, headband, surgical
00732094002485Light, headband, surgical
00732094001723Light, headband, surgical

Maude Adverse Events

INTEGRA?INTEGRA YORK PA, INC.2020-01-29
DUO HEADLIGHT 2 BAY SYSTEM - USINTEGRA LIFESCIENCES CORP2019-08-25
BATTERY CHARGER, SINGLE BAYINTEGRA YORK, PA INC.2019-06-14
LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - USINTEGRA YORK, PA INC.2018-08-16
LED HEADLIGHT ONLYINTEGRA YORK, PA INC.2017-02-14
LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - AUINTEGRA YORK, PA INC.2017-01-31
LITHIUM ION BATTERIES - QTY 2INTEGRA YORK, PA INC.2016-05-20
LITHIUM ION BATTERIES - QTY 2INTEGRA YORK, PA INC.2016-05-20
LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - AUINTEGRA YORK, PA INC.2016-05-09
SAPPHIRERIVERPOINT MEDICAL2015-12-02
BATTERY CHARGER, SINGLE BAYINTEGRA BURLINGTON, MA, INC.2015-07-08
BATTERY CHARGER, SINGLE BAYINTEGRA BURLINGTON, MA, INC.2015-04-24
LED HEADLIGHT W/ BATTERIES &AC/DC POWER SUPPLY -USINTEGRA BURLINGTON, MA, INC.2015-03-10
LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - USINTEGRA BURLINGTON, MA, INC2015-02-19
LED HEADLIGHT W/ BATTERIES AND AC/DC POWER SUPPLY - USINTEGRA BURLINGTON, MA, INC.2014-10-16
SOLARMAXX300SUNOPTIC2014-10-13
ANCILLARY, HEADBAND UL PLUS BIINTEGRA BURLINGTON, MA, INC.2014-08-22
ANCILLARY, HEADBAND UL PLUS BIINTEGRA BURLINGTON, MA, INC.2014-08-22
ANCILLARY, HEADBAND UL PLUS BIINTEGRA BURLINGTON, MA, INC.2014-08-22
LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - USINTEGRA BURLINGTON MA, INC.2014-07-15
LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - USINTEGRA BURLINGTON, MA, INC.2012-11-09
ULTRALITE PRO HEADLAMPINTEGRA, BURLINGTON2011-04-29
SUNOPTIC HEADLIGHT CORD/CABLESUNOPTIC TECHNOLOGIES2009-02-11
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