FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Gastroenterology & Urology ×
9,870 results
5449–5472 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 15, 1995
GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS
K952342 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 119d
Cleared Sep 15, 1995
BIOACCESS BONE BIOPSY SYSTEM
K954151 · KNW
Bioaccess, Inc.
Gastroenterology & Urology · 10d
Cleared Sep 13, 1995
DILATATION CATHETER, BALLOON
K953004 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 77d
Cleared Sep 13, 1995
CONVEEN LEG BAG STRAP
K953783 · FAQ
Coloplast Corp.
Gastroenterology & Urology · 30d
Cleared Sep 12, 1995
INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS
K945498 · FGE
Instent, Inc.
Gastroenterology & Urology · 308d
Cleared Sep 12, 1995
GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE
K954155 · FCG
Promex, Inc.
Gastroenterology & Urology · 7d
Cleared Sep 08, 1995
INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS
K924387 · FGE
Instent, Inc.
Gastroenterology & Urology · 1103d
Cleared Sep 08, 1995
ANALGRAPH
K941801 · KLA
Sandhill Scientific, Inc.
Gastroenterology & Urology · 514d
Cleared Sep 08, 1995
GAMBRO LUNDIA 94-500 DIALYZER
K945746 · FJI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 289d
Cleared Sep 08, 1995
GAMBRO LUNDIA 94-600 DIALYZER
K945747 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 289d
Cleared Sep 08, 1995
REDDY ILLUMINATOR
K950960 · FFS
Luxtec Corp.
Gastroenterology & Urology · 190d
Cleared Sep 08, 1995
UROVISION JANUS
K953353 · FEN
Life-Tech Intl., Inc.
Gastroenterology & Urology · 53d
Cleared Sep 08, 1995
NG SECURE
K953375 · KNT
M.C. Johnson Co., Inc.
Gastroenterology & Urology · 52d
Cleared Sep 08, 1995
BIOPSY NEEDLE
K953880 · KNW
Biopsys Medical, Inc.
Gastroenterology & Urology · 21d
Cleared Sep 08, 1995
URESIL INTRODUCING NEEDLE
K953923 · KNW
Uresil Corp.
Gastroenterology & Urology · 21d
Cleared Sep 01, 1995
GIP/MEDI-GLOBE ERCP CATHETERS
K953827 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 17d
Cleared Aug 30, 1995
MANAN NEPHROSTOMY DRAINAGE CATHETER
K953547 · LJE
Manan Medical Products, Inc.
Gastroenterology & Urology · 33d
Cleared Aug 28, 1995
DIALYZER REPROCESSING SYSTEM
K944492 · LIF
G.E.M. Water Systems
Gastroenterology & Urology · 349d
Cleared Aug 28, 1995
MOSS(R) STEEL BREAKAWAY(R) INTRODUCER
K945480 · KOB
Harry A. Schlakman
Gastroenterology & Urology · 293d
Cleared Aug 28, 1995
PRG BUTTON
K946140 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 255d
Cleared Aug 24, 1995
ASEPTECH PORTABLE RO+ SYSTEM
K924695 · FIP
Dayton Water Systems
Gastroenterology & Urology · 1071d
Cleared Aug 24, 1995
FLOLAB
K951442 · EXY
Synectics Medical, Inc.
Gastroenterology & Urology · 148d
Cleared Aug 24, 1995
SWISS LITHOCLAST LITHOTRIPTER
K951531 · FFK
Electro Medical Systems SA
Gastroenterology & Urology · 143d
Cleared Aug 24, 1995
ROLLER ELECTRODE
K951863 · FAS
Olympus America, Inc.
Gastroenterology & Urology · 125d