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
7513–7536 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 23, 1987
HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES
K873487 · FIP
Water Pure, Inc.
Gastroenterology & Urology · 53d
Cleared Oct 23, 1987
ADR-22 AUTOMATIC DIALYZER REPROCESSOR
K874034 · LIF
Biodynamics Corp.
Gastroenterology & Urology · 18d
Cleared Oct 20, 1987
GENERAL PURPOSE COMBINATION PH ELECTRODE
K871921 · FFT
Chemfet Corp.
Gastroenterology & Urology · 155d
Cleared Oct 20, 1987
PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA.
K871922 · FFT
Chemfet Corp.
Gastroenterology & Urology · 155d
Cleared Oct 20, 1987
SECURLINE FRANSEENE NEEDLE
K873369 · KNW
Precision Dynamics Corp.
Gastroenterology & Urology · 60d
Cleared Oct 20, 1987
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
K873984 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 20d
Cleared Oct 14, 1987
STOMACH EVACULATOR - EWALD STYLE
K864963 · KOA
Medovations, Inc.
Gastroenterology & Urology · 296d
Cleared Oct 14, 1987
P. URINE METER, 250CC
K872824 · KNX
Ni-Med, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 14, 1987
LASER OPTICAL FIBERS - DISPOSABLE
K872870 · LNK
Optimed Therapeutics
Gastroenterology & Urology · 86d
Cleared Oct 14, 1987
HUFFMAN BIOPSY UNIT
K873176 · FCL
Penn Medical Devices, Inc.
Gastroenterology & Urology · 63d
Cleared Oct 14, 1987
DEVINE (SUPRAPUBIC SOUND AND GUIDE)
K873177 · KOE
Penn Medical Devices, Inc.
Gastroenterology & Urology · 63d
Cleared Oct 14, 1987
MODIFIED RECTAL NOZZLE
K873948 · KPL
Colon Therapeutics
Gastroenterology & Urology · 16d
Cleared Oct 13, 1987
ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER
K871526 · EXB
Cox Family Laboratories, Inc.
Gastroenterology & Urology · 176d
Cleared Oct 13, 1987
DIALY-NATE SET & DIALY-NATE CATHETER
K872221 · FKO
Gesco Intl., Inc.
Gastroenterology & Urology · 126d
Cleared Oct 13, 1987
HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
K872364 · FII
Travenol Laboratories, S.A.
Gastroenterology & Urology · 117d
Cleared Oct 09, 1987
LOW PROFILE GASTROSTOMY
K872771 · KNT
Microvasive
Gastroenterology & Urology · 87d
Cleared Oct 09, 1987
KAWASUMI A.V. FISTULA SET
K873421 · FKQ
Kawasumi Laboratories Co., Ltd.
Gastroenterology & Urology · 45d
Cleared Oct 05, 1987
HOSPAL DIALYSATE FOR C.A.V.H.D.
K872857 · KPO
Delmed, Inc.
Gastroenterology & Urology · 76d
Cleared Oct 05, 1987
LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET
K873435 · KOD
Level 1 Technologies, Inc.
Gastroenterology & Urology · 40d
Cleared Oct 05, 1987
KAWASUMI BLOOD TUBING LINE
K873516 · FJK
Kawasumi Laboratories Co., Ltd.
Gastroenterology & Urology · 35d
Cleared Sep 30, 1987
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
K872652 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 85d
Cleared Sep 30, 1987
URETERAL BULB DILATORS
K873178 · EZN
Penn Medical Devices, Inc.
Gastroenterology & Urology · 49d
Cleared Sep 22, 1987
LINDEN STONE EXTRACTION BALLOON
K872509 · FGE
Hobbs Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Sep 21, 1987
AN3200 DOUBILET DRAIN
K872458 · FGE
H.W. Andersen Products, Inc.
Gastroenterology & Urology · 90d