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
9097–9120 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 26, 1981
FORDER RETRACTOR
K811693 · KOA
Dacomed Corp.
Gastroenterology & Urology · 11d
Cleared Jun 23, 1981
AUTOMATED GASTRIC LAVAGE
K811061 · KNT
Emergency Medicine
Gastroenterology & Urology · 67d
Cleared Jun 23, 1981
MODEL DM-333 DIALYSIS CONTROL STATION
K811444 · FKQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 32d
Cleared Jun 23, 1981
MODEL RS-8100
K811457 · KOC
Rinal Systems, Inc.
Gastroenterology & Urology · 32d
Cleared Jun 23, 1981
MODEL FUS-1, FLEXIBLE URETEROSCOPE
K811535 · FGB
American Optical Corp.
Gastroenterology & Urology · 22d
Cleared Jun 18, 1981
QUINTON CATHETER FINGER GRIP
K811266 · FKO
Quinton, Inc.
Gastroenterology & Urology · 37d
Cleared Jun 16, 1981
CHEMATIC BICARBONATE DIALYSATE SYSTEM
K810605 · FKR
Trimedyne, Inc.
Gastroenterology & Urology · 102d
Cleared Jun 16, 1981
SUR-FIT LOOP OSTOMY O.R. SET
K811240 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 12, 1981
GAMBRO PERITONEAL DIALYSIS FLUID LINES
K811294 · KDJ
Gambro, Inc.
Gastroenterology & Urology · 32d
Cleared Jun 12, 1981
EXP 200 PARALLEL PLATE DIALYZER
K811439 · FJG
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 21d
Cleared Jun 12, 1981
EXP 600 PARALLEL PLATE DIALYZER
K811440 · FJG
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 21d
Cleared Jun 12, 1981
MMG URINARY DRAINAGE TUBING
K811469 · KNX
Medical Marketing Group
Gastroenterology & Urology · 17d
Cleared Jun 09, 1981
COBE PPD .8
K810066 · FJG
Cobe Laboratories, Inc.
Gastroenterology & Urology · 147d
Cleared Jun 09, 1981
SUR-FIT DISPOSABLE CONVEX INSERT
K811239 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 09, 1981
ECONOMY OPEN END DRAINAGE BAG
K811300 · EXB
Economy Plus
Gastroenterology & Urology · 29d
Cleared Jun 09, 1981
VANCE PROSTATIC ASPIRATION SET
K811454 · KNW
Vance Products, Inc.
Gastroenterology & Urology · 18d
Cleared Jun 02, 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726 · EXB
Howmedica Corp.
Gastroenterology & Urology · 77d
Cleared Jun 02, 1981
ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT
K810979 · KNT
Arrow Intl., Inc.
Gastroenterology & Urology · 53d
Cleared Jun 02, 1981
SUR-FIT IRRIGATION SLEEVE
K811160 · EXD
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 35d
Cleared Jun 02, 1981
PARALLEL PLATE DIALYZER HOLDER
K811292 · FKI
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 22d
Cleared May 21, 1981
SUR-FIT DISPOSABLE FANGE CAP
K811163 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 23d
Cleared May 21, 1981
VASOVASOSTOMY STABILIZER PLATFORM DEV
K811223 · KOA
Biomet, Inc.
Gastroenterology & Urology · 17d
Cleared May 08, 1981
LIXIVITRON
K802828 · LIF
United Medical
Gastroenterology & Urology · 179d
Cleared May 08, 1981
CAPD CATHETER ADAPTER
K810683 · FKX
American Mcgaw
Gastroenterology & Urology · 56d