Seratronics, Inc. - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Seratronics, Inc. Gastroenterology & Urology ✕
20 devices
Cleared
Oct 21, 1996
DPS 4 DIALYZER PREPARATION SYSTEM
Gastroenterology & Urology
336d
Cleared
Apr 18, 1996
DRS 4 DIALYZER REPROCESSING SYSTEM
Gastroenterology & Urology
1129d
Cleared
Nov 29, 1995
DRS 4 ND DIALYZER REPROCESSING SYSTEM
Gastroenterology & Urology
440d
Cleared
Aug 29, 1994
DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES
Gastroenterology & Urology
774d
Cleared
Feb 24, 1992
DRS-4 DIALYZER REPROCESSING SYSTEM
Gastroenterology & Urology
131d
Cleared
Apr 25, 1988
FRESENIUS PURISTERIL 340 (TM)
Gastroenterology & Urology
172d
Cleared
Feb 19, 1988
FRESENIUS HEMOFLOW F3, F4, F5, F7
Gastroenterology & Urology
84d
Cleared
May 01, 1987
FRESENIUS HEMOFLOW F6 AND F8
Gastroenterology & Urology
66d
Cleared
Apr 01, 1987
FRESENIUS HEMOFLOW F60 AND F80
Gastroenterology & Urology
36d
Cleared
Mar 03, 1987
FRESENIUS ULTRAFLUX AV400, AV600
Gastroenterology & Urology
102d
Cleared
Nov 06, 1986
FRESENIUS HEMOFLOW F50 & F70
Gastroenterology & Urology
13d
Cleared
Apr 07, 1986
DRS-4 DIALYZER REPROCESSING SYSTEM
Gastroenterology & Urology
42d
Cleared
Apr 07, 1986
FRESENIUS HEMOFLOW F80 DIALYZER
Gastroenterology & Urology
14d
Cleared
Jan 21, 1986
FRESENIUS HEMODIALYSIS MACHINE A1008 BSM
Gastroenterology & Urology
39d
Cleared
Nov 12, 1985
FRESENIUS DISPOSABLE BLOOD LINES
Gastroenterology & Urology
57d
Cleared
Jul 25, 1985
FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40
Gastroenterology & Urology
63d
Cleared
Feb 15, 1985
FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD
Gastroenterology & Urology
71d
Cleared
Feb 14, 1985
FRESENIUS HAEMODIALYSIS
Gastroenterology & Urology
78d
Cleared
Oct 14, 1983
DIALYZER PREPARATION SYS DPS-4
Gastroenterology & Urology
95d
Cleared
Oct 18, 1982
DIALYZER REPROCESSING SYSTEM DRS-4
Gastroenterology & Urology
116d