Premarket Submissions

DEVICE NAME APPLICANT K NUMBER SUBMISSION TYPE PRODUCT CODE
BARCOMED 5MP2 BARCO NV K000016 Traditional LLZ
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400 RD MEDICAL MFG., INC. K000017 Abbreviated FPA
BRANEMARK NOVUM NOBEL BIOCARE UAS INC K000018 Traditional DZE
SINGLE SIZE TENDON SPACER MEDIST INTERNATIONAL K000019 Traditional HXA
MODIFICATION TO ISOBAR SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. K000020 Special MNH
AESCULAP BONE WAX AESCULAP, INC. K000021 Traditional MTJ
HARDYDISK CEFAMANDOLE, 30MCG HARDY DIAGNOSTICS K000022 Traditional JTN
FRIENDLY LIGHT ER:YAG PULSED LASER INNOTECH USA, INC. K000023 Traditional GEX
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER APPLE MEDICAL CORP. K000026 Traditional HHK
INSUFFLATION NEEDLE, MODEL R65-933 A & A MEDICAL, INC. K000027 Traditional HIF
RENAFLO II HF 2000 HEMOFILTER MINNTECH CORP. K000028 Traditional KDI
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS ELA MEDICAL, INC. K000029 Traditional DTB
SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. K000030 Traditional IYO
AQUANET, MODEL EC 2000 PRIME PACIFIC HEALTH INNOVATIONS CORPORATION K000031 Traditional KPL
LEVEEN NEEDLE ELECTRODE RADIOTHERAPEUTICS CORP. K000032 Traditional GEI
OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM OPTIMAL IMAGING SYSTEMS, INC. K000034 Traditional IYN
OMNICARE DENTAL IMPLANT SYSTEM OMNICARE DENTAL IMPLANT CENTER K000035 Traditional DZE
ENTEC REFLEX WAND 55, MODEL E4055-00 ARTHROCARE CORP. K000036 Traditional GEI
MONOFILAMENT BIOSYN SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC K000037 Traditional GAM
INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED INDUS MEDICARE LTD. K000038 Abbreviated HIS
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