Light, Surgical, Endoscopic
General, Plastic Surgery · 21 CFR 878.4580
Recent MDR events
5 adverse event reports on file
- L300 SURGICAL ILLUMINATORAug 28, 2012MalfunctionIntegra Burlington, Ma Inc.1222895-2012-00025
- CV EVOLUTIONS SAPHLITENov 10, 2008MalfunctionTeleflex Medical1044475-2008-00038
- STRYKERApr 19, 2006MalfunctionStryker Endoscopy709918
- STORZFeb 27, 2006MalfunctionKarl Storz Endoscopy-america, Inc.719666
- LIQUID LIGHT CABLEJun 19, 1997OtherSmith & Nephew, Inc Endoscopy Division1216828-1997-00003
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
Alira Medical Devices Llc
Rancho Cucamonga, CA, US
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Teleflex Llc (nadc)
Olive Branch, MS, US
Long Island Technology Group Llc
Farmingdale, NY, US
Heinrich Medizintechnik Gmbh
Stuttgart Baden-Wurttemberg, DE
Sunoptic Technologies, Llc
JACKSONVILLE, FL, US
Rusun Medical Co., Ltd
Yichun City Jiangxi, CN
Teleflex Medical Llc
Morrisville, NC, US
Eclipse Prism Medical Devices Pvt. Ltd
RABALE, NAVI MUMBAI Maharashtra, IN
510(k) clearances
8 clearances for this product code
- Genzyme BiosurgeryNov 25, 2002
K022989 · RADLITE TISSUE RETRACTOR SYSTEM
- Aculux, Inc.Feb 1, 2002
K013511 · XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)
- M.P. Video, Inc.Oct 17, 1994
K943342 · MEDICAM XENON LIGHT SOURCE
- Cuda Products Co.Nov 18, 1993
K934337 · CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
- Medical Illumination, Inc.Sep 2, 1992
K922279 · ILLUMINATOR IV MINOR SURGERY LIGHT
- Leisegang Medical, Inc.Sep 18, 1991
K913135 · LM-300TWIN
- Medical Dynamics, Inc.Oct 3, 1989
K894319 · MEDICAL DYNAMICS LIGHT SOURCE
- Medline Industries, Inc.Mar 18, 1987
K870898 · ULTRA-LUX LIGHT SOURCE