Andover Medical, Inc. - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Andover Medical, Inc. Cardiovascular ✕
16 devices
Cleared
Feb 07, 1991
CANMED 451
Cardiovascular
45d
Cleared
Jan 12, 1989
MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE
Cardiovascular
30d
Cleared
May 09, 1986
FASTRACE III, ECG ELECTRODE
Cardiovascular
77d
Cleared
May 08, 1986
ECG MONITORING/DEFIBRILLATION ELECTRODE
Cardiovascular
184d
Cleared
Mar 31, 1986
AMI CARDIO-PAD
Cardiovascular
62d
Cleared
Nov 20, 1984
FLOW-DIRECTED PEDIATRIC THERMODIL- CATH
Cardiovascular
81d
Cleared
Nov 20, 1984
FLOW DIRECTED THERMODILUTION CATH W/VEN
Cardiovascular
81d
Cleared
Oct 18, 1984
FLOW-DIRECTED THERMODILUTION CATH
Cardiovascular
48d
Cleared
Oct 18, 1984
THERMAL DILUTION CATHETER
Cardiovascular
48d
Cleared
Dec 30, 1982
HOLTER KIT MODEL #5000 SERIES
Cardiovascular
45d
Cleared
Oct 15, 1982
DISPOSABLE ELECTRODE #1900
Cardiovascular
29d
Cleared
Nov 02, 1981
THE NEW 1600 ELECTRODE
Cardiovascular
19d
Cleared
Sep 25, 1981
DISPOSABLE ELECTRODE, #1610
Cardiovascular
43d
Cleared
Jun 19, 1978
SELF-RETAINING ELECTRODE SER. #4000-100
Cardiovascular
14d
Cleared
Aug 23, 1976
ELECTRODE SERIES 1401
Cardiovascular
31d
Cleared
Aug 23, 1976
ELECTRODE SERIES 1600
Cardiovascular
21d