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
9553–9576 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 17, 1978
DIALYZER, DISP., COIL, LUNDIA
K781102 · FHS
Gambro, Inc.
Gastroenterology & Urology · 106d
Cleared Oct 10, 1978
PAPILLOTOME CUTTING SNARE
K781353 · KNS
Cameron-Miller, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 27, 1978
PM 2000 AUTOMATIC PATIENT CHAIR
K781597 · FFG
Time Motion System Co.
Gastroenterology & Urology · 12d
Cleared Sep 26, 1978
DLC 500, DOUBLE LUMEN CATHETER
K781050 · KOC
Hemodialysis, Division of The
Gastroenterology & Urology · 97d
Cleared Sep 20, 1978
OSTOMY APPLIANCE W/DEODORIZING FILTER
K781373 · EXB
Hollister, Inc.
Gastroenterology & Urology · 44d
Cleared Sep 20, 1978
COMFORM ABSORBANT INCONTINENCE PADS
K781375 · EYQ
Kimberly-Clark Corp.
Gastroenterology & Urology · 42d
Cleared Sep 20, 1978
FOLEY CATHETERS
K781457 · KOD
Intermed, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 14, 1978
DISSCAP
K781142 · FJI
Hospal Medical Corp.
Gastroenterology & Urology · 66d
Cleared Sep 07, 1978
PATIENT AID, MODEL DM-351
K781176 · FKQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 57d
Cleared Sep 07, 1978
GAVAGE ADMIN. SET
K781230 · KNT
Mcgaw Laboratories
Gastroenterology & Urology · 51d
Cleared Sep 07, 1978
DOBBHOFF ENTERIC FEEDING BAG
K781385 · FPD
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 27d
Cleared Sep 07, 1978
KWIK-FLO URINAL SYSTEM
K781422 · KNX
The Grace Mfg. Co.
Gastroenterology & Urology · 21d
Cleared Aug 31, 1978
STERILE URETHRAL CATHETER KIT
K760897 · KOD
Diamed Division Ill. Tool Works, Inc.
Gastroenterology & Urology · 674d
Cleared Aug 31, 1978
MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT
K780932 · FIZ
Western Laboratories Corp.
Gastroenterology & Urology · 86d
Cleared Aug 31, 1978
TEST MODULE MODEL DM-352
K781215
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 45d
Cleared Aug 23, 1978
C-DAK 4000 ARTIFICIAL KIDNEY
K781058 · FJI
Cordis Corp.
Gastroenterology & Urology · 61d
Cleared Aug 18, 1978
OSTOMY APPLIANCE BELT
K781088 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 17, 1978
K-Z CONCENTRATE
K781011 · EXB
K-Zyme Labs, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 14, 1978
ENEMA BAG
K780877 · FCE
Abco Dealers, Inc.
Gastroenterology & Urology · 76d
Cleared Aug 14, 1978
HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM
K781038 · KNW
Quinton, Inc.
Gastroenterology & Urology · 56d
Cleared Jul 31, 1978
LEG BAG
K780878 · KNX
Abco Dealers, Inc.
Gastroenterology & Urology · 62d
Cleared Jul 31, 1978
URETHRO CATHETERIZATION TRAY
K780879 · FCM
Abco Dealers, Inc.
Gastroenterology & Urology · 62d
Cleared Jul 28, 1978
NITE TRAIN'R
K780660 · KPN
Nite Train-R Enterprises, Inc.
Gastroenterology & Urology · 99d
Cleared Jul 27, 1978
PAPILLOTOMY KNIVES
K780774 · KNS
Olympus Corp.
Gastroenterology & Urology · 85d