Gould, Inc. - FDA 510(k) Cleared Devices
31
Total
31
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gould, Inc. Cardiovascular ✕
29 devices
Cleared
Jul 22, 1991
CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
Cardiovascular
82d
Cleared
Aug 18, 1986
MODEL SP1465 CARDIAC OUTPUT COMPUTER
Cardiovascular
147d
Cleared
May 08, 1986
PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337
Cardiovascular
65d
Cleared
Feb 26, 1986
MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR
Cardiovascular
64d
Cleared
Oct 17, 1985
GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX
Cardiovascular
185d
Cleared
Feb 22, 1985
C/PES 9201, ECG STRESS TESTING SYS
Cardiovascular
39d
Cleared
Feb 08, 1985
C/PES 9103, ECG STRESS TESTING SYSTEM
Cardiovascular
25d
Cleared
Feb 01, 1985
CARDIAC COMPUTER SP1445
Cardiovascular
144d
Cleared
Jan 23, 1985
MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
Cardiovascular
104d
Cleared
Jun 15, 1984
AUTOMATED NON-INVASIVE PRESSURE MODULE
Cardiovascular
107d
Cleared
May 23, 1984
HEPARIN COATED THERMODILUTION CATHETERS
Cardiovascular
89d
Cleared
May 23, 1984
THERMODILUTION CATHETER
Cardiovascular
77d