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
2809–2832 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 12, 2009
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
K083838 · MNW
Fook Tin Technologies Limited
Gastroenterology & Urology · 140d
Cleared May 11, 2009
FSC 2
K090601 · NTN
Schoelly Imaging, Inc.
Gastroenterology & Urology · 67d
Cleared May 08, 2009
ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
K090338 · MSY
Reprocessing Products Corp
Gastroenterology & Urology · 87d
Cleared May 08, 2009
MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
K091257 · FCG
Medi-Globe Corporation
Gastroenterology & Urology · 9d
Cleared May 07, 2009
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
K091152 · OTM
Coloplast A/S
Gastroenterology & Urology · 17d
Cleared May 04, 2009
FOOTPRINT MEDICAL SILICONE FEEDING TUBE
K090559 · KNT
Footprint Medical
Gastroenterology & Urology · 63d
Cleared Apr 23, 2009
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
K090217 · FBK
Coloplast A/S
Gastroenterology & Urology · 84d
Cleared Apr 22, 2009
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
K083374 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 160d
Cleared Apr 22, 2009
FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
K090116 · FDF
Fujinon, Inc.
Gastroenterology & Urology · 91d
Cleared Apr 20, 2009
MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
K090814 · FAJ
Gyrus Acmi, Inc.
Gastroenterology & Urology · 26d
Cleared Apr 15, 2009
PRE-FILLED CATHETER INFLATION SYRINGE
K090121 · KNY
Avail Medical Products, Inc.
Gastroenterology & Urology · 84d
Cleared Apr 13, 2009
PROGUIDE CHRONIC DIALYSIS CATHETER
K090148 · MSD
Merit Medical Systems, Inc.
Gastroenterology & Urology · 82d
Cleared Apr 09, 2009
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K090663 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 07, 2009
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510,...
K083627 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 120d
Cleared Mar 30, 2009
NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P,...
K082719 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 194d
Cleared Mar 20, 2009
BODYMETRIX BX2000
K082147 · OMV
Intelametrix, Inc.
Gastroenterology & Urology · 233d
Cleared Mar 20, 2009
SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND...
K083802 · FCG
Medi-Globe Corporation
Gastroenterology & Urology · 88d
Cleared Mar 19, 2009
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
K083675 · NIE
C.R. Bard, Inc.
Gastroenterology & Urology · 98d
Cleared Mar 12, 2009
HEMOBAND, MODELS HB-NS AND HB-NSXL
K081740 · KOC
Innovations For Access, Inc.
Gastroenterology & Urology · 266d
Cleared Mar 09, 2009
SILS STITCH ENDOSCOPIC SUTURING DEVICE
K090419 · OCW
Covidien Lp, Formerly Registered AS...
Gastroenterology & Urology · 19d
Cleared Mar 05, 2009
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S
K083776 · FPD
Corpak Medsystems
Gastroenterology & Urology · 76d
Cleared Mar 04, 2009
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S
K083791 · FPD
Corpak Medsystems
Gastroenterology & Urology · 75d
Cleared Mar 03, 2009
GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
K083471 · OTN
Generic Medical Device, Inc.
Gastroenterology & Urology · 99d
Cleared Mar 03, 2009
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
K083788 · EYB
Endooptiks, Inc.
Gastroenterology & Urology · 74d