Premarket Submissions

DEVICE NAME APPLICANT K NUMBER SUBMISSION TYPE PRODUCT CODE
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT CORDIS CORP. K000062 Traditional DTK
CAMLOG CYLINDER IMPLANT SYSTEM ALTATEC BIOTECHNOLOGIES K000065 Special DZE
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM SYNTHES (USA) K000066 Traditional HRS
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H TECO DIAGNOSTICS K000067 Special CJE
COMPUMEDICS E-SERIES EEG SYSTEM COMPUMEDICS NEURO SCIENCE PTY LTD. K000068 Traditional OLT
FLOCATH RUSCH INTL. K000070 Traditional KOD
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT EAGLE PLASTIC PRODUCTS CO., LTD K000071 Traditional LYZ
DORNIER MEDILAS D SKINPULSE DORNIER SURGICAL PRODUCTS, INC. K000072 Traditional GEX
MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA MERCURY MEDICAL K000073 Traditional GXI
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS ARTHROCARE CORP. K000074 Special GEI
CELL-CHEX STRECK LABORATORIES, INC. K000076 Traditional GJR
STERIS AMSCO MILLENNIUM STEAM STERILIZER STERIS Corporation K000077 Special FLE
JETLITE 4000 J. MORITA USA, INC. K000078 Traditional EBZ
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M NIKOMED U.S.A., INC. K000079 Special HAM
ASNIS III CANNULATED SCREW SYSTEM HOWMEDICA OSTEONICS CORP. K000080 Traditional HWC
MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM ISOTOPES AND METALS LTD. K000081 Traditional JAQ
EBI XFIX DFS RAIL SYSTEM EBI, L.P. K000083 Special KTT
ENRAF-NONIUS SONOPULS 190 SYSTEM HENLEY HEALTHCARE, INC. K000084 Traditional IMI
PORTSETT PORTSETT, INC. K000085 Traditional FMI
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS WILSON-COOK MEDICAL, INC. K000086 Traditional KGE
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