Premarket Submissions

DEVICE NAME APPLICANT K NUMBER SUBMISSION TYPE PRODUCT CODE
OHMEDA INOVENT DELIVERY SYSTEM OHMEDA MEDICAL DEN000001 Post-NSE MRN
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM BOSTON SCIENTIFIC SCIMED, INC. K000001 Traditional JCT
UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE UROSURGE, INC. DEN000002 Post-NSE NAM
MAGNA 5000 PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. K000002 Traditional MOS
TORNIER TOTAL ELBOW PROSTHESIS TORNIER K000003 Traditional JDC
QUICKAIR CHOKE RELIEVER, MODEL 59-001A MAET INDUSTRIES, INC. DEN000004 Post-NSE MZT
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 DAIG CORP. K000004 Traditional DYB
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 DIAGNOSTIC PRODUCTS CORP. K000005 Traditional LEG
EROS-CLITORAL THERAPY DEVICE (CTD) UROMETRICS, INC. DEN000006 Post-NSE NBV
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 DIAGNOSTIC PRODUCTS CORP. K000006 Traditional DIP
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 DIAGNOSTIC PRODUCTS CORP. K000007 Traditional KLT
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA INOVA DIAGNOSTICS, INC. DEN000007 Post-NSE NBT
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. DEN000008 Post-NSE NDS
SPIRAL RADIUS RODDING SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC K000009 Abbreviated KWQ
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED DEN000010 Post-NSE NBC
MODIFIED HYDROPHILIC COATED GUIDEWIRE LAKE REGION MFG., INC. K000011 Special DQX
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 DIAGNOSTIC PRODUCTS CORP. K000012 Traditional DLZ
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 ACIST MEDICAL SYSTEMS K000013 Special DXT
BARCOMED 5MP1H BARCO NV K000014 Traditional LLZ
BARCOMED 2MP2 BARCO NV K000015 Traditional LLZ
© 2023 MedicalDeviceHub, LLC