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
9385–9408 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 26, 1980
TRIEX-2 HOLLOW FIBER DIALYZER
K800270 · FJI
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 20d
Cleared Feb 13, 1980
GAMBRO LUNDIA COIL DIALYZER
K800174 · FHS
Gambro, Inc.
Gastroenterology & Urology · 19d
Cleared Feb 06, 1980
CONTINUOUS AMBULATORY DIALYSIS (CAPD)
K791512 · KDJ
Norton Performance Plastics Corp.
Gastroenterology & Urology · 201d
Cleared Feb 06, 1980
RECTAL LEAKAGE INHIBITOR
K792597 · KNT
Augustin Jones, M.D.
Gastroenterology & Urology · 51d
Cleared Feb 06, 1980
GAMBRO LUNDIA PLATE DIALYZER
K792611 · FJG
Gambro, Inc.
Gastroenterology & Urology · 50d
Cleared Feb 06, 1980
CAPD TRANSFER SET JC9044
K792651 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 47d
Cleared Jan 16, 1980
SURGIFEED
K791714 · KNT
Health Development Corp.
Gastroenterology & Urology · 139d
Cleared Jan 16, 1980
SORB SYSTEM URS
K792137 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 86d
Cleared Jan 16, 1980
MODEL 7620 LINE CLAMP
K792277 · KOC
B-D Drake Willock
Gastroenterology & Urology · 64d
Cleared Jan 16, 1980
BAKER INTESTINAL TUBE, TWIN CUFF
K792333 · KNT
Intl. Hospital Products, Inc.
Gastroenterology & Urology · 58d
Cleared Jan 16, 1980
C-DAK 2100 ARTIFICIAL KIDNEY
K792419 · FJI
Cordis Corp.
Gastroenterology & Urology · 50d
Cleared Jan 16, 1980
3 WAY URETHRAL IRRIGATION CATHETER
K792719 · KOD
Vesta, Inc.
Gastroenterology & Urology · 19d
Cleared Jan 04, 1980
RENAL SYSTEMS HEMODIALYSIS CONCENTRATE
K792213 · KPO
Renal Systems, Inc.
Gastroenterology & Urology · 63d
Cleared Dec 20, 1979
STONE AND RETRIEVAL BASKET
K792344 · FFL
Mill-Rose Laboratory
Gastroenterology & Urology · 31d
Cleared Dec 20, 1979
RETRIEVABLE FORCEPS
K792345 · OCZ
Mill-Rose Laboratory
Gastroenterology & Urology · 31d
Cleared Dec 20, 1979
STOMAHESIVE POWDER
K792382 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 24d
Cleared Dec 20, 1979
POLAROID LAND CAMERA FOR ENDOSCOPY
K792512 · FEM
Polaroid Corp.
Gastroenterology & Urology · 15d
Cleared Dec 10, 1979
PERIDIAL PERITONEAL DIALYSIS TRAY
K792207 · FKG
Cutter Laboratories, Inc.
Gastroenterology & Urology · 38d
Cleared Dec 10, 1979
PENTEX UPPER G.I. SCOPE MODEL FG-28A
K792215 · GCT
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 35d
Cleared Dec 10, 1979
PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34
K792341 · FAM
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 21d
Cleared Dec 10, 1979
BONGORT ODOR BARRIER DRAIN
K792381 · EXB
Howmedica Corp.
Gastroenterology & Urology · 14d
Cleared Dec 06, 1979
PERITONEAL DIALYSIS CYCLER MODEL PDC1000
K791676 · KPF
J.M. Sounds Electronics Co.
Gastroenterology & Urology · 101d
Cleared Dec 06, 1979
ERIKA NEGATIVE PRESSURE ARTERILA BLOOD
K792053 · FJK
Erika, Inc.
Gastroenterology & Urology · 52d
Cleared Dec 06, 1979
ERIKA NEGATIVE PRESSURE VENOUS BL SETS
K792054 · FJK
Erika, Inc.
Gastroenterology & Urology · 52d