Spectramed, Inc. - FDA 510(k) Cleared Devices
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spectramed, Inc. Cardiovascular ✕
8 devices
Cleared
Nov 06, 1989
CCO SYSTEM MODEL SP1467,SP5567,SP6267
Cardiovascular
199d
Cleared
Jan 25, 1989
SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
Cardiovascular
36d
Cleared
Sep 28, 1988
MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH
Cardiovascular
152d
Cleared
May 25, 1988
HEPARIN COATED LUMINAL PACING CATHETER
Cardiovascular
147d
Cleared
Jan 12, 1988
SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS
Cardiovascular
154d
Cleared
Sep 16, 1987
CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS
Cardiovascular
147d
Cleared
Apr 20, 1987
SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM
Cardiovascular
111d
Cleared
Mar 06, 1987
V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540
Cardiovascular
112d