Andover Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K905729CANMED 451February 7, 1991
K903427NORTECH MODEL 86901000 ELECTRODEAugust 17, 1990
K885171MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLEJanuary 12, 1989
K860636FASTRACE III, ECG ELECTRODEMay 9, 1986
K854433ECG MONITORING/DEFIBRILLATION ELECTRODEMay 8, 1986
K860535UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)April 1, 1986
K860283AMI CARDIO-PADMarch 31, 1986
K843412FLOW DIRECTED THERMODILUTION CATH W/VENNovember 20, 1984
K843410FLOW-DIRECTED PEDIATRIC THERMODIL- CATHNovember 20, 1984
K843411THERMAL DILUTION CATHETEROctober 18, 1984
K843409FLOW-DIRECTED THERMODILUTION CATHOctober 18, 1984
K831785NEURO EASEJune 30, 1983
K823414HOLTER KIT MODEL #5000 SERIESDecember 30, 1982
K822798DISPOSABLE ELECTRODE #1900October 15, 1982
K812878THE NEW 1600 ELECTRODENovember 2, 1981
K812276DISPOSABLE ELECTRODE, #1610September 25, 1981
K810271DIRECT CURRENT BONE GROWTH STIM. AN. PADFebruary 19, 1981
K790316ELECTRODE, ELECTROFLEXMarch 27, 1979
K780908SELF-RETAINING ELECTRODE SER. #4000-100June 19, 1978
K760280ELECTRODE SERIES 1401August 23, 1976