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
8041–8064 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 09, 1985
MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT
K852363 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 66d
Cleared Aug 09, 1985
MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE
K852679 · LKX
J. & Jp., Inc.
Gastroenterology & Urology · 45d
Cleared Aug 09, 1985
URETERAL DILATOR/SHEATH SET
K852793 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 39d
Cleared Aug 09, 1985
PROTECTIVE PAD FOR INCONTINENCE
K853079 · EYQ
I.C.D. Industries, Inc.
Gastroenterology & Urology · 17d
Cleared Aug 08, 1985
AMSCO URO-ENDO MOBILE TABLE
K852127 · KQS
American Sterilizer Co.
Gastroenterology & Urology · 85d
Cleared Aug 08, 1985
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET
K852287 · KOB
Cook Ob/Gyn
Gastroenterology & Urology · 71d
Cleared Aug 08, 1985
CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW
K852792 · KNT
Corpak Co.
Gastroenterology & Urology · 38d
Cleared Aug 07, 1985
UROBEI STRESS INCONTINENCE MONITOR
K851483 · FAP
Browne Medical, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 07, 1985
EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA
K852014 · KOA
Effner and Spreine Co.
Gastroenterology & Urology · 90d
Cleared Aug 07, 1985
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG
K852085 · KNX
The Kendal Co.
Gastroenterology & Urology · 86d
Cleared Aug 07, 1985
SIMPLASTIC SUPRA PUBIC CATHETER
K852200 · KOB
Franklin Medical USA, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 07, 1985
ESTEEM INCONTINENT SYSTEM
K852276 · EYQ
Bevan Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Aug 02, 1985
URETERAL STONE DISLODGER
K851922 · FFL
Inter-Med Corp.
Gastroenterology & Urology · 92d
Cleared Jul 29, 1985
RINSE MACHINE KR-4 KIDNEY RINSE-4
K850799 · LIF
Medical Technologies International, Inc.
Gastroenterology & Urology · 152d
Cleared Jul 29, 1985
HEMOCONCENTRATOR KIT
K850979 · KDI
Omnis Surgical, Inc.
Gastroenterology & Urology · 143d
Cleared Jul 29, 1985
VAN-TEC GUIDE WIRE W/HYDROMER COATING
K851160 · KOD
Van-Tec, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 29, 1985
SOEHENDRA BILIARY DILATING CATHETER-SBDC-7
K851960 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 29, 1985
WILSON-COOK STONE EXTRACTOR
K851965 · FFL
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 29, 1985
BLOOD TUBING SET
K852605 · FJK
Medflex International, Inc.
Gastroenterology & Urology · 40d
Cleared Jul 29, 1985
CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353
K852678 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 34d
Cleared Jul 29, 1985
FIBERLASE 100 MEDICAL LASER SYSTEM
K852798 · LNK
Laser Media
Gastroenterology & Urology · 28d
Cleared Jul 26, 1985
STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN
K850214 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 185d
Cleared Jul 26, 1985
HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES
K851236 · FJK
Infarkem Corp.
Gastroenterology & Urology · 121d
Cleared Jul 26, 1985
VARICES INJECTOR
K851952 · FBK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 84d