Lamp, Surgical

Product Code: FTD

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 FTD

5523Lamp, SurgicalSurgical Lamp.

Total Product Life Cycle (TPLC) Devices

5523Lamp, SurgicalSurgical Lamp.

Pre-market Notifications for FTD

K133425SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHTENGINEERED MEDICAL SOLUTIONS CO. LLC.
K130513VOLISTA 400; VOLISTA 600MAQUET SAS
K123776POLARIS 100/200DRAGER MEDICAL GMBH
K111020ATRICURE DISSECTORATRICURE, INC.
K100884STRYKER KNIFELIGHTHOWMEDICA OSTEONICS CORP.
K100234HM-LAMP IIHILLUSA, INC.
K071180SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001ENGINEERED MEDICAL SOLUTIONS CO. LLC
K053364HALUX IRIS EXAMINATION AND SURGICAL LAMPWALDMANN LIGHTING
K041681ATRICURE DISSECTORATRICURE, INC.
K013242AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEMSTERIS Corporation
K010724SOLA 700,SOLA 500, SOLA 300DRAGER MEDIZINTECHNIK GMBH
K003423ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055ST. FRANCIS MEDICAL EQUIPMENT CO., LTD.
K981717STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTORSTRYKER INSTRUMENTS
K961122STRYKER KNIFELIGHTSTRYKER INSTRUMENTS
K954263XE-LITEOPHTHALMIC TECHNOLOGIES, INC.

Global Unique Device Identification Database

04048675416562Lamp, Surgical
04048675295495Lamp, Surgical
04048675268109Lamp, Surgical
34546540060113Lamp, surgical
M710SL122Lamp, Surgical
07898027903601Lamp, Surgical
03700712400903Lamp, surgical
03700712400880Lamp, surgical
03700712400873Lamp, surgical
03700712400842Lamp, surgical
03700712400835Lamp, surgical
03700712400811Lamp, surgical
08050705890415Lamp, Surgical
03700712415709Lamp, Surgical
00887761995956Lamp, surgical

Maude Adverse Events

HANAULUXMAQUET SAS2020-03-13
POWERLED IIMAQUET SAS2020-03-13
2020-02-18
2020-02-18
2020-02-18
2020-02-18
2020-02-18
POWERLED IIMAQUET SAS2019-12-12
VOLISTA STANDOPMAQUET SAS2019-12-10
VOLISTA STANDOPMAQUET SAS2019-12-10
HANAULUX 2000MAQUET SAS2019-12-05
POWERLED IIMAQUET SAS2019-11-25
POWERLED IIMAQUET SAS2019-11-25
CENTURION LIGHTMEDICAL ILLUMINATION INTRNATION INC.2019-11-04
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-28
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-28
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-24
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-23
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-23
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-10-23
TRIANGO 30WALDMANN LIGHTING2019-10-07
WOLF LUMITIP DISSECTORATRICURE, INC.2019-08-28
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18
UNKNOWN KNIFELIGHTSTRYKER GMBH2019-07-18

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