FDA 510(k) Applications for Medical Device Product Code "GAD"
(Retractor)

FDA 510(k) Number Applicant Device Name Decision Date
K050256 APPLE MEDICAL CORP. APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR 04/26/2005
K980588 CLARUS MEDICAL SYSTEMS, INC. CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 08/18/1998
K071775 EZSURGICAL DASH 08/07/2007
K152538 J.R. PARKER, LLC JRP Wound Spreader 04/13/2016
K043602 MEDTRONIC SOFAMOR DANEK QUADRANT RETRACTOR SYSTEM 02/23/2005
K132645 MEDTRONIC, INC. THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES 10/04/2013
K001339 OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. MRI FASTSYSTEM RETRACTOR SYSTEM 05/17/2000
K963006 SCION INTERNATIONAL, INC. SCION SAPHENOUS VEIN HARVESTING SYSTEM 09/20/1996
K151104 SPINEART OTELO LL 01/06/2016


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