FDA 510(k) Applications for Medical Device Product Code "FSS"
(Light, Surgical, Floor Standing)

FDA 510(k) Number Applicant Device Name Decision Date
K984124 AESCULAP, INC. AESCULAP XENON LIGHT SOURCE 02/01/1999
K981821 ANGIOLAZ, INC. VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR 07/29/1998
K981469 CUDA PRODUCTS CO. CERMAX300 LIGHTSOURCE 07/09/1998
K981962 CUDA PRODUCTS CO. CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE 08/18/1998
K961074 CUDA PRODUCTS CO. LIGHTSOURCE OR ILLUMINATOR 04/30/1996
K970886 HERAEUS MED GMBH HANAULUX BLUE 80 HOSPITAL 04/16/1997
K003489 MEDICAL ILLUMINATION INTERNATIONAL, INC. NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 02/02/2001
K980044 PERKINELMER OPTOELECTRONICS XENON 300MX 04/03/1998
K961971 Stryker Endoscopy Q-5000 06/28/1996
K091246 TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) 09/28/2009


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