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
8065–8088 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 26, 1985
ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1
K852309 · FJK
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Jul 26, 1985
NATURALYTE BICARBONATE CONCENTRATE-DRY PACK
K852310 · FKQ
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Jul 25, 1985
SAVARY-GILLIARD DILATOR
K851955 · KNQ
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Jul 25, 1985
ROTATABLE POLYPECTOMY SNARE POS-1
K851958 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Jul 25, 1985
FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40
K852251 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 25, 1985
MODEL SA3 ESOPHAGEAL PH ELECTRODE
K852289 · FFT
World Precision Instruments, Inc.
Gastroenterology & Urology · 57d
Cleared Jul 24, 1985
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
K844810 · KNX
C.R. Bard, Inc.
Gastroenterology & Urology · 225d
Cleared Jul 24, 1985
THE HENLEY BOARD S.I.D. SPINAL IMMOBILIZATION DEVI
K852100 · FPD
Henley Board, Inc.
Gastroenterology & Urology · 70d
Cleared Jul 15, 1985
UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER
K851857 · KOD
Sheridan Catheter Corp.
Gastroenterology & Urology · 80d
Cleared Jul 09, 1985
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
K850020 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 186d
Cleared Jul 09, 1985
NYHUS/NELSON TUBE
K851672 · KNT
Bissell Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Jul 09, 1985
BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420
K852725 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 13d
Cleared Jul 09, 1985
ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420
K852726 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 13d
Cleared Jul 03, 1985
OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO
K851647 · FGE
Meadox Surgimed, Inc.
Gastroenterology & Urology · 72d
Cleared Jul 02, 1985
DIALYSIS CONCENTRATE
K851319
Ries Biologicals
Gastroenterology & Urology · 91d
Cleared Jul 02, 1985
UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER
K851684 · KOD
Urotec Systems Corp.
Gastroenterology & Urology · 70d
Cleared Jul 02, 1985
1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS
K851719 · EZZ
Artiberia
Gastroenterology & Urology · 68d
Cleared Jul 02, 1985
MENTOR UNIVERSAL URETERAL STENT SET
K851870 · FAD
Mentor Corp.
Gastroenterology & Urology · 64d
Cleared Jun 28, 1985
SAFESTRETCH INCONTINENCE SYSTEM
K851681 · KNX
Dbt Medical , Ltd.
Gastroenterology & Urology · 66d
Cleared Jun 27, 1985
QRI-FLOW URINE FLOW MEASURING DEVICE
K851266 · KNX
Bio-Flow, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 27, 1985
OSTOMY BAGS URETHEROSTOMY
K851678 · EXB
Dbt Medical , Ltd.
Gastroenterology & Urology · 65d
Cleared Jun 27, 1985
OSTOMY BAGS COLOSTOMY
K851679 · EXB
Dbt Medical , Ltd.
Gastroenterology & Urology · 65d
Cleared Jun 27, 1985
OSTOMY BAGS ILEOSTOMY
K851680 · EXB
Dbt Medical , Ltd.
Gastroenterology & Urology · 65d
Cleared Jun 24, 1985
PAPILLOTOME
K851652 · KNS
Microvasive
Gastroenterology & Urology · 63d