Hem Con Medical Technologies, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Prometheus ChitoGauze XR PRO, HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO, GUARDACARE
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hem Con Medical Technologies, Inc. General & Plastic Surgery ✕
9 devices
Cleared
May 25, 2016
Prometheus ChitoGauze XR PRO
General & Plastic Surgery
162d
Cleared
CT
Nov 10, 2015
HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First...
General & Plastic Surgery
218d
Cleared
Jun 16, 2011
GUARDACARE
General & Plastic Surgery
185d
Cleared
May 17, 2011
CHITOGAUZE FUSION
General & Plastic Surgery
21d
Cleared
Nov 17, 2010
CHITOGAUZE
General & Plastic Surgery
75d
Cleared
Aug 25, 2009
CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4...
General & Plastic Surgery
21d
Cleared
Mar 31, 2009
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
General & Plastic Surgery
85d
Cleared
Aug 06, 2008
MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
General & Plastic Surgery
337d
Cleared
May 15, 2008
HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING
General & Plastic Surgery
52d