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
4441–4464 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 23, 1999
DUCPREP BREAST ASPIRATOR, MODEL PMPO2
K993342 · KNW
Windy Hill Technology, Inc.
Gastroenterology & Urology · 79d
Cleared Dec 23, 1999
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
K993651 · GBM
Sc Hennig Enterprises Europe Srl
Gastroenterology & Urology · 55d
Cleared Dec 23, 1999
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K994068 · FGE
Cordis Corp.
Gastroenterology & Urology · 21d
Cleared Dec 22, 1999
HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED...
K992390 · KGE
Telemed Systems, Inc.
Gastroenterology & Urology · 156d
Cleared Dec 22, 1999
5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X...
K992402 · KNS
Telemed Systems, Inc.
Gastroenterology & Urology · 156d
Cleared Dec 22, 1999
SPACE-OR RETRACTOR
K993544 · FFO
Advanced Surgical Concepts (Asc)
Gastroenterology & Urology · 64d
Cleared Dec 17, 1999
BIOTEQUE A.V. FISTULA NEEDLE SET
K993118 · FIE
Bioteque Corp.
Gastroenterology & Urology · 88d
Cleared Dec 15, 1999
TRIP TONOMETRY CATHETER, 14F
K993296 · KNT
Datex-Ohmeda, Inc.
Gastroenterology & Urology · 75d
Cleared Dec 15, 1999
AED CYSTOSCOPE
K993689 · FAJ
National Advanced Endoscopy Devices,...
Gastroenterology & Urology · 44d
Cleared Dec 10, 1999
CUSTODIOL
K992209 · KDN
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 163d
Cleared Dec 10, 1999
ENDOSCOPES,10MM DIAMETER 0 DEGREES
K993103 · GCM
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 85d
Cleared Dec 10, 1999
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006
K993226 · EZD
Memcath Technologies, LLC
Gastroenterology & Urology · 74d
Cleared Dec 10, 1999
BARDEX I.C. PEDIATRIC FOLEY CATHETER
K993464 · MJC
C.R. Bard, Inc.
Gastroenterology & Urology · 58d
Cleared Dec 09, 1999
RUSCH BRILLANT SILICONE FOLEY
K993063 · EZL
Rusch Intl.
Gastroenterology & Urology · 87d
Cleared Dec 07, 1999
BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
K984168 · FCF
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 382d
Cleared Dec 07, 1999
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
K990643 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 284d
Cleared Dec 06, 1999
MANUAL BONE MARROW BIOPSY DEVICE
K993435 · KNW
Promex, Inc.
Gastroenterology & Urology · 55d
Cleared Dec 06, 1999
OMNISONIC ENDOSCOPIC DEFLECTOR
K993445 · GCM
Omnisonics Medical Technologies
Gastroenterology & Urology · 55d
Cleared Nov 30, 1999
CKHEMO, MODEL CKHEMO VERSION 1.0
K992255 · FKP
Csam, Inc.
Gastroenterology & Urology · 147d
Cleared Nov 29, 1999
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
K993721 · KPI
Laborie Medical Tech Corp.
Gastroenterology & Urology · 26d
Cleared Nov 28, 1999
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K993646 · FGE
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Nov 26, 1999
PBN DILATORS
K990808 · FGE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 260d
Cleared Nov 24, 1999
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K992894 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 89d
Cleared Nov 22, 1999
FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
K993046 · FEO
Fibra Sonics, Inc.
Gastroenterology & Urology · 73d