Promex, Inc.

FDA Regulatory Profile

Promex, Inc. appears in FDA public data with 0 recalls, 18 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Dec 19, 2002.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K023450BIOPSY SITE TISSUE MARKER DEVICEDec 19, 2002
K022634CO-AXIAL INTRODUCER NEEDLENov 6, 2002
K010400VACUUM ASSISTED CORE BIOPSY DEVICEJul 24, 2001
K011270AUTOMATED CORE BIOPSY DEVICEJun 22, 2001
K001132BONE BIOPSY NEEDLEMay 1, 2000
K994272AUTOMATED CORE BIOPSY DEVICEJan 7, 2000
K993435MANUAL BONE MARROW BIOPSY DEVICEDec 6, 1999
K973184PROSTATE SEEDING NEEDLENov 21, 1997
K972865PROMEX ENT TISSUE REMOVAL SYSTEMSep 29, 1997
K961078AUTOMATED VITRECTOMY DEVICEJun 14, 1996
K960023KIRSHNER WIRES (K-WIRE) & STEINMANN PINSMar 18, 1996
K960405SPINAL NEEDLEFeb 28, 1996
K955168SURGICAL CUTTERJan 22, 1996
K954265TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLESep 29, 1995
K954231AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENTSep 22, 1995
K954155GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLESep 12, 1995
K945146CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLEDec 21, 1994
K945124BREAST LESION LOCALIZATION NEEDLENov 22, 1994