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
6313–6336 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 01, 1992
UROLOGICAL BALLOON DILATATION CATHETER
K920946 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 121d
Cleared Jun 30, 1992
SD-200IEHL(TM)
K914517 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 265d
Cleared Jun 24, 1992
AUTOMATIC TUBING CLAMP
K914459 · FIG
Rocky Mountain Research, Inc.
Gastroenterology & Urology · 261d
Cleared Jun 24, 1992
FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT
K915735 · KNT
Abbott Laboratories
Gastroenterology & Urology · 187d
Cleared Jun 16, 1992
VERIMED PERINEOMETER
K913912 · HIR
Verimed Holdings, Inc.
Gastroenterology & Urology · 292d
Cleared Jun 11, 1992
MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION
K913817 · FFT
Synectics-Dantec
Gastroenterology & Urology · 290d
Cleared Jun 11, 1992
OLYMPIC SMART SCALE CARE CENTER
K920423 · FEW
Olympic Medical Corp.
Gastroenterology & Urology · 132d
Cleared Jun 10, 1992
4 SURE TM COLOSTOMY POUCH
K922401 · EZQ
Boston Pacific Medical, Inc.
Gastroenterology & Urology · 20d
Cleared Jun 02, 1992
PHOENIX 5 URODYNAMICS SYSTEM
K914300 · FAP
Aspen Medical , Ltd.
Gastroenterology & Urology · 251d
Cleared May 15, 1992
GIANTURCO-ROSCH BILIARY Z STENT
K921191 · FGE
Cook, Inc.
Gastroenterology & Urology · 78d
Cleared May 11, 1992
DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE
K920409 · LKY
Dacomed Corp.
Gastroenterology & Urology · 101d
Cleared May 11, 1992
KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER
K921055 · KNY
Kendall Healthcare Products Co....
Gastroenterology & Urology · 67d
Cleared May 08, 1992
ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT
K914887 · FRQ
Mallinckrodt Medical
Gastroenterology & Urology · 191d
Cleared May 06, 1992
CHOLANGIOGRAM CATHETER KIT
K920236 · FGE
Mccol Medical,Inc.
Gastroenterology & Urology · 110d
Cleared May 06, 1992
ENTRAC URETHRAL BALLOON DILATATION CATHETER
K920711 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 78d
Cleared May 06, 1992
DOBBHOFF BIPOLAR ADAPTER
K921029 · KNS
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 64d
Cleared May 04, 1992
INSERTION
K920515 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 90d
Cleared Apr 28, 1992
PH METER, MODIFICATION
K914624 · FFT
Synectics-Dantec
Gastroenterology & Urology · 195d
Cleared Apr 28, 1992
DECOMPRESSION TUBES
K920894 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 67d
Cleared Apr 27, 1992
BARD 4-WIRE URETEROSCOPIC STONE
K921233 · FFL
C.R. Bard, Inc.
Gastroenterology & Urology · 45d
Cleared Apr 24, 1992
URETEROMAT 4400
K915751 · EZN
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 123d
Cleared Apr 24, 1992
PRESSURE GAUGE
K921026 · KNT
Hobbs Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Apr 23, 1992
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET
K914936 · LFK
Akcess Medical Products, Inc.
Gastroenterology & Urology · 171d
Cleared Apr 20, 1992
VIVAMED FISTULA NEEDLE
K903440 · FIE
S.S. Ent.
Gastroenterology & Urology · 629d