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Promex, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K023450BIOPSY SITE TISSUE MARKER DEVICEDecember 19, 2002
K022634CO-AXIAL INTRODUCER NEEDLENovember 6, 2002
K010400VACUUM ASSISTED CORE BIOPSY DEVICEJuly 24, 2001
K011270AUTOMATED CORE BIOPSY DEVICEJune 22, 2001
K001132BONE BIOPSY NEEDLEMay 1, 2000
K994272AUTOMATED CORE BIOPSY DEVICEJanuary 7, 2000
K993435MANUAL BONE MARROW BIOPSY DEVICEDecember 6, 1999
K973184PROSTATE SEEDING NEEDLENovember 21, 1997
K972865PROMEX ENT TISSUE REMOVAL SYSTEMSeptember 29, 1997
K961078AUTOMATED VITRECTOMY DEVICEJune 14, 1996
K960023KIRSHNER WIRES (K-WIRE) & STEINMANN PINSMarch 18, 1996
K960405SPINAL NEEDLEFebruary 28, 1996
K955168SURGICAL CUTTERJanuary 22, 1996
K954265TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLESeptember 29, 1995
K954231AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENTSeptember 22, 1995
K954155GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLESeptember 12, 1995
K945146CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLEDecember 21, 1994
K945124BREAST LESION LOCALIZATION NEEDLENovember 22, 1994