Premarket Submissions

DEVICE NAME APPLICANT K NUMBER SUBMISSION TYPE PRODUCT CODE
INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED INDUS MEDICARE LTD. K000039 Abbreviated HIS
INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED INDUS MEDICARE LTD. K000040 Abbreviated HIS
ELECSYS B-CROSSLAPS CALCHECK ROCHE DIAGNOSTICS CORP. K000042 Traditional JJX
DRG AURICA ELISA TESTOSTERONE KIT DRG INTL., INC. K000043 Traditional CDZ
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINEWANDS ARTHROCARE CORP. K000044 Special GEI
POSITUBE PARAPRODUCTS, INC. K000045 Traditional BTR
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) RICHARD WOLF MEDICAL INSTRUMENTS CORP. K000046 Traditional HRX
SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1 BIOSURGICAL CORP. K000048 Special FMF
SUNI MAX SATELEC K000049 Traditional EFB
TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES TOP QUALITY MFG., INC. K000050 Traditional LYY
ACTICOAT FOAM DRESSING WESTAIM BIOMEDICAL, INC. K000051 Traditional FRO
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 DYNARAD CORP. K000052 Traditional ITY
ACL 9000 SYSTEM INSTRUMENTATION LABORATORY CO. K000053 Traditional JPA
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN ADRI K000054 Traditional KGN
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 DIAGNOSTIC CHEMICALS LTD. K000055 Traditional CGX
BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS BIOCELL LABORATORIES, INC. K000056 Traditional JJX
RADIONICS LUMBOPERITONEAL SHUNT RADIONICS, INC. K000057 Traditional JXG
BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES KAOHSIUNG BROTHERS PRODUCTS CORP. K000058 Traditional LYZ
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007 SENORX, INC. K000060 Traditional GDW
MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT MINXRAY, INC. K000061 Traditional EHD
© 2023 MedicalDeviceHub, LLC