Medical Device Manufacturer · US , Bedford , MA

Spire Biomedical, Inc.

16 submissions · 12 cleared · Since 2002
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.

16 devices
1–12 of 16
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
K073092 · MSD Catheter, Hemodialysis, Implanted · Gastroenterology & Urology
Jan 2008 89d
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,
K073093 · MSD Catheter, Hemodialysis, Implanted · Gastroenterology & Urology
Jan 2008 82d
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55
K063441 · MSD Catheter, Hemodialysis, Implanted · Gastroenterology & Urology
Feb 2007 90d
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
K063431 · MSD Catheter, Hemodialysis, Implanted · Gastroenterology & Urology
Jan 2007 77d
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
K062435 · NFK Kit, Repair, Catheter, Hemodialysis · Gastroenterology & Urology
Dec 2006 106d
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
K060288 · MSD Catheter, Hemodialysis, Implanted · Gastroenterology & Urology
Sep 2006 207d
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS
K060155 · MSD Catheter, Hemodialysis, Implanted · Gastroenterology & Urology
May 2006 109d
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
K042858 · MSD Catheter, Hemodialysis, Implanted · Gastroenterology & Urology
Dec 2004 49d
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55
K041559 · MSD Catheter, Hemodialysis, Implanted · Gastroenterology & Urology
Jul 2004 50d
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40
K040509 · MSD Catheter, Hemodialysis, Implanted · Gastroenterology & Urology
Apr 2004 52d
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH
K032061 · MSD Catheter, Hemodialysis, Implanted · Gastroenterology & Urology
Dec 2003 173d
RETRO REPAIR KIT, MODEL PRRK5
K022644 · NFK Kit, Repair, Catheter, Hemodialysis · Gastroenterology & Urology
Nov 2002 90d
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