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
7153–7176 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 31, 1989
LEONARD TUBE
K892334 · KDH
Surgidyne, Inc.
Gastroenterology & Urology · 56d
Cleared May 30, 1989
URODEC 500
K890284 · FES
Ferguson Medical
Gastroenterology & Urology · 131d
Cleared May 30, 1989
TECNOL NASO-GASTRIC TUBE HOLDER
K891187 · BSS
Tecnol New Jersey Wound Care, Inc.
Gastroenterology & Urology · 85d
Cleared May 24, 1989
HEALTHSHIELD
K885345 · KPN
Jonas, Inc.
Gastroenterology & Urology · 147d
Cleared May 24, 1989
MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177
K892648 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 42d
Cleared May 23, 1989
ENTERAL BAG/SET
K890151 · KNT
Ashley Health Care, Inc.
Gastroenterology & Urology · 130d
Cleared May 23, 1989
EXTERNAL FEEDING SET FOR PUMP USE
K890396 · FPD
Multi-Med, Inc.
Gastroenterology & Urology · 119d
Cleared May 23, 1989
CLOSED SYSTEM URINARY DRAINAGE BAG
K890465 · EYZ
Cypress Medical Products, Ltd.
Gastroenterology & Urology · 112d
Cleared May 23, 1989
TECNOL SECURE-ALL TUBE HOLDER
K891178 · EYZ
Tecnol New Jersey Wound Care, Inc.
Gastroenterology & Urology · 78d
Cleared May 19, 1989
KENDALL CURITY FEEDING TUBES
K892431 · FPD
The Kendal Co.
Gastroenterology & Urology · 39d
Cleared May 18, 1989
NEW AM-SERIES DIALYZERS
K892374 · FJI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 48d
Cleared May 18, 1989
MODIFIED AM-SERIES DIALYZERS
K892375 · FJI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 48d
Cleared May 18, 1989
PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD
K892870 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 29d
Cleared May 18, 1989
PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD
K892871 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 29d
Cleared May 18, 1989
PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD
K892872 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 29d
Cleared May 15, 1989
ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA
K892887 · FIQ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 25d
Cleared May 11, 1989
FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM
K890329 · FIL
Fresenius USA, Inc.
Gastroenterology & Urology · 108d
Cleared May 11, 1989
FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM
K890824 · FKP
Fresenius USA, Inc.
Gastroenterology & Urology · 83d
Cleared May 11, 1989
GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY
K892523 · FJI
Gambro, Inc.
Gastroenterology & Urology · 30d
Cleared May 10, 1989
NICKLE-TITANIUM ORTHODONTIC WIRE
K891327 · FJF
American Orthodontics
Gastroenterology & Urology · 61d
Cleared May 09, 1989
RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU
K892542 · FFN
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 28d
Cleared May 09, 1989
BEST COLON CLAMP
K892550 · FFN
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 28d
Cleared May 08, 1989
LIGHT SOURCE, ENDOSCOP, XENON ARC
K890448 · FFS
Mira, Inc.
Gastroenterology & Urology · 101d
Cleared May 08, 1989
PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE
K891109 · KNT
Concept, Inc.
Gastroenterology & Urology · 67d