Spectra Medical Devices, Inc. - FDA 510(k) Cleared Devices
Recent clearances: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle, SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE, STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spectra Medical Devices, Inc. General Hospital ✕
4 devices
Cleared
Jul 29, 2011
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
General Hospital
219d
Cleared
Mar 20, 2009
STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
General Hospital
186d
Cleared
Nov 28, 2008
SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP,...
General Hospital
74d
Cleared
Jul 29, 2008
SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML...
General Hospital
57d