Spire Biomedical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Spire Biomedical, Inc. - FDA 510(k) Cleared Devices
16
Total
12
Cleared
0
Denied
Spire Biomedical, Inc. has 12 FDA 510(k) cleared gastroenterology & urology devices. Based in Bedford, US.
Historical record: 12 cleared submissions from 2002 to 2008.
Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Spire Biomedical, Inc.
16 devices
Cleared
Jan 29, 2008
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS...
Gastroenterology & Urology
89d
Cleared
Jan 22, 2008
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS...
Gastroenterology & Urology
82d
Cleared
Feb 12, 2007
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28,...
Gastroenterology & Urology
90d
Cleared
Jan 29, 2007
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24,...
Gastroenterology & Urology
77d
Cleared
Dec 05, 2006
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
Gastroenterology & Urology
106d
Cleared
Sep 01, 2006
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
Gastroenterology & Urology
207d
Cleared
May 09, 2006
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH...
Gastroenterology & Urology
109d
Cleared
Dec 03, 2004
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
Gastroenterology & Urology
49d
Cleared
Jul 30, 2004
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL...
Gastroenterology & Urology
50d
Cleared
Apr 19, 2004
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28,...
Gastroenterology & Urology
52d
Cleared
Dec 23, 2003
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH,...
Gastroenterology & Urology
173d
Cleared
Nov 06, 2002
RETRO REPAIR KIT, MODEL PRRK5
Gastroenterology & Urology
90d
Cleared
Oct 11, 2002
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND...
Gastroenterology & Urology
65d
Cleared
Jul 19, 2002
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS...
Gastroenterology & Urology
30d
Cleared
May 17, 2002
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED...
Gastroenterology & Urology
30d
Cleared
Apr 11, 2002
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
Gastroenterology & Urology
202d