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
5809–5832 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 29, 1994
KLEIN RECTAL TAMPNADE BALLOON
K933842 · KNT
Cook Urological, Inc.
Gastroenterology & Urology · 419d
Cleared Sep 29, 1994
MASTER ALERT
K934848 · FIP
Master Hydro Systems, Inc.
Gastroenterology & Urology · 343d
Cleared Sep 29, 1994
TECHNA-CUT ASPIRATION NEEDLE
K943651 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 63d
Cleared Sep 28, 1994
MIC TRANSGASTRIC JEJUNAL TUBE
K926581 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 727d
Cleared Sep 28, 1994
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
K930623 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 597d
Cleared Sep 28, 1994
SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE
K931963 · FFT
Sandhill Scientific, Inc.
Gastroenterology & Urology · 525d
Cleared Sep 28, 1994
GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS
K935198 · KNT
Lake Region Mfg., Inc.
Gastroenterology & Urology · 336d
Cleared Sep 28, 1994
KARL STORZ ENDOVISION UROCAM/HYSTEROCAM
K940283 · FET
Medical Concepts, Inc.
Gastroenterology & Urology · 252d
Cleared Sep 26, 1994
THE BIOPSY TOOL
K941563 · FCG
Citation Medical Corp.
Gastroenterology & Urology · 178d
Cleared Sep 23, 1994
CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS...
K934610 · FJS
Tabex Industries, Inc.
Gastroenterology & Urology · 361d
Cleared Sep 21, 1994
KSEA CONTINOUS FLOW CYSTOSCOPE
K943668 · FBO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 55d
Cleared Sep 21, 1994
UROLOGICAL GUIDWIRE
K944135 · KNY
Applied Medical Resources
Gastroenterology & Urology · 28d
Cleared Sep 20, 1994
WALLSTENT ESOPHAGEAL PROSTHESIS
K940395 · ESW
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 236d
Cleared Sep 20, 1994
THE KARL STORZ UROMAT(TM)
K940983 · LJH
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 203d
Cleared Sep 16, 1994
BARD URINE COLLECTION PRODUCTS MODIFICATION
K940206 · KNX
C.R. Bard, Inc.
Gastroenterology & Urology · 245d
Cleared Sep 14, 1994
TROCARS,CANNULAE,SHEATHS,OBTURATORS
K943697 · ODB
Karl Storz Endoskop GmbH
Gastroenterology & Urology · 47d
Cleared Sep 12, 1994
HEMODIALYSIS BATH
K922990 · KPO
Medi-Tech, Inc.
Gastroenterology & Urology · 812d
Cleared Sep 12, 1994
PASSPORT
K941853 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 151d
Cleared Sep 09, 1994
KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
K940594 · FGA
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 212d
Cleared Sep 08, 1994
NON-BALLOON REPLACEMENT GASTROSTOMY KIT
K932295 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 485d
Cleared Sep 08, 1994
CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
K934072 · KNY
Contour Fabricators of Florida, Inc.
Gastroenterology & Urology · 384d
Cleared Sep 08, 1994
FOLEY CATHETERIZATION TRAY
K942177 · FCM
Customed, Inc.
Gastroenterology & Urology · 127d
Cleared Sep 08, 1994
NAVARRE 600 ML DRAINAGE BAG
K943663 · EXF
Navarre Biomedical , Ltd.
Gastroenterology & Urology · 42d
Cleared Sep 07, 1994
MICROCYCLER
K915166 · FCN
Medical Inventors Corp., Inc.
Gastroenterology & Urology · 1027d