Premarket Submissions

DEVICE NAME APPLICANT K NUMBER SUBMISSION TYPE PRODUCT CODE
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST ADVANTAGE DIAGNOSTICS CORP K023712 Traditional DKZ
SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 SONTRA MEDICAL INC. K023713 Traditional KRC
REPROCESSED EXTERNAL FIXATION DEVICE ALLIANCE MEDICAL CORP. K023714 Traditional KTT
STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM STARMATRIX SDN BHD K023715 Traditional LYY
SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP SPS MEDICAL SUPPLY CORP. K023716 Special FRC
SPERM WASH MEDIUM WITH GENTAMICIN CONCEPTION TECHNOLOGIES K023717 Traditional MQL
QUICKSET MIMIX BONE VOID FILLER WALTER LORENZ SURGICAL, INC. K023718 Special GXP
MP-1 MICRO PERIMETER NIDEK TECHNOLOGIES SRL K023719 Traditional HKI
SONOLINE ANTARES ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. K023720 Traditional IYN
BONART ART-L2 LIGHT CURING UNIT BONART CO. LTD. K023721 Traditional EBZ
SAFETYWAND DISPOSABLE HANDPIECE SPINTECH, INC. K023722 Traditional EJI
FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 FMS, FINAPRES MEDICAL SYSTEMS BV K023723 Traditional DXN
DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT HOWMEDICA OSTEONICS CORP. K023724 Traditional JWH
HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 MARINA MEDICAL INSTRUMENTS, INC. K023725 Traditional GDW
TENS PRO 900 ACUMED MEDICAL SUPPLIES, LTD. K023726 Traditional GZJ
TEMPORARY CEMENT-DC010002 GC AMERICA, INC. K023727 Traditional EMA
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR CANOPUS MEDICAL SUPPLY CO., LTD. K023728 Traditional LYZ
SIASCOPE II ASTRON CLINICA LIMITED K023729 Traditional PSN
QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 CONSOLIDATED TECHNOLOGY K023731 Traditional JJY
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR CIBA VISION CORPORATION K023732 Traditional LPL
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