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
5689–5712 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 09, 1995
LIBERTY
K943250 · KPI
Utah Medical Products, Inc.
Gastroenterology & Urology · 218d
Cleared Feb 09, 1995
4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
K945495 · EXY
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 93d
Cleared Feb 07, 1995
RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP
K943879 · FAS
American Urologicals, Inc.
Gastroenterology & Urology · 182d
Cleared Feb 07, 1995
OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
K944391 · FEN
Surgitek
Gastroenterology & Urology · 151d
Cleared Feb 07, 1995
GABRIEL URETERAL ILLUMINATOR SYSTEM II
K945088 · FCS
Gabriel Medical, Inc.
Gastroenterology & Urology · 113d
Cleared Feb 07, 1995
KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP
K945210 · LJH
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 105d
Cleared Feb 07, 1995
QC CAP
K945567 · KDJ
Medionics International, Inc.
Gastroenterology & Urology · 133d
Cleared Feb 07, 1995
BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP
K945813 · FCG
Bd Becton Dickinson Vacutainer...
Gastroenterology & Urology · 71d
Cleared Feb 07, 1995
KARL STORZ BOUGIES AND DILATORS
K950125 · FAX
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 26d
Cleared Feb 07, 1995
PREMIE U-BAG URINE SPECIMEN COLLECTOR
K950176 · FOC
Hollister, Inc.
Gastroenterology & Urology · 21d
Cleared Feb 03, 1995
VISION SYSTEM COLONSCOPE
K943895 · FDF
Vision-Sciences, Inc.
Gastroenterology & Urology · 178d
Cleared Feb 01, 1995
RADIUS ENTERAL FEEDING TUBE
K930510 · BSS
Radius Intl., Inc.
Gastroenterology & Urology · 730d
Cleared Feb 01, 1995
SERIM(TM) BICARB PH REAGENT STRIPS
K945491 · MNV
Serim Research Corp.
Gastroenterology & Urology · 85d
Cleared Feb 01, 1995
ECHO STAR NEEDLE SET
K945921 · FCG
Ideamatrix
Gastroenterology & Urology · 58d
Cleared Jan 31, 1995
ALL SILICONE INTERMITTENT CATHETER
K943851 · GBM
Rochester Medical Corp.
Gastroenterology & Urology · 176d
Cleared Jan 31, 1995
URETHRAL SUTURE GUIDE
K950267 · KOA
Applied Medical Resources
Gastroenterology & Urology · 8d
Cleared Jan 30, 1995
PRISM MEDICAL CUSTOM DIALYSIS KIT
K941803 · KOC
Medical Device Support Services
Gastroenterology & Urology · 293d
Cleared Jan 30, 1995
HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP
K945764 · KNS
Aaron Medical Industries
Gastroenterology & Urology · 90d
Cleared Jan 27, 1995
ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY
K935781 · FEG
Sherwood Medical Co.
Gastroenterology & Urology · 417d
Cleared Jan 25, 1995
GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER
K933818 · KDI
C.G.H. Medical, Inc.
Gastroenterology & Urology · 539d
Cleared Jan 24, 1995
CYBERRX MODEL 7200
K934434 · FFT
Cybermed Control Systems, Inc.
Gastroenterology & Urology · 519d
Cleared Jan 24, 1995
BALLOON DILATION CATHETER
K935094 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 459d
Cleared Jan 24, 1995
PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
K943835 · KNY
Orion Life Systems, Inc.
Gastroenterology & Urology · 172d
Cleared Jan 24, 1995
WILSON COOK MULTIPLE BAND LIGATOR
K944220 · MND
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 148d