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
7681–7704 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 25, 1987
SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22
K863609 · FKP
International Medical Products, Inc.
Gastroenterology & Urology · 162d
Cleared Feb 25, 1987
MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.
K870270 · FKT
Ash Medical Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 25, 1987
ACUTE PERITONEAL DIALYSIS KIT
K870472 · FKO
Quinton, Inc.
Gastroenterology & Urology · 22d
Cleared Feb 24, 1987
SUCTION TUBE
K864770 · FFA
New England Surgical Instrument Corp.
Gastroenterology & Urology · 81d
Cleared Feb 20, 1987
COMPRESS AND SKULLCAP, HEAD DRESSING
K870240 · EXR
Fraass Survival Systems, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 18, 1987
NEW SECOND FRENCH SIZE MAHURKAR CATHETER
K865096 · LFK
Quinton, Inc.
Gastroenterology & Urology · 50d
Cleared Feb 13, 1987
ACUSON S519B TRANSDUCER
K863236
Acuson Computed Sonography
Gastroenterology & Urology · 176d
Cleared Feb 12, 1987
CYTOSTATIC FILTRATION SET
K863218 · LFK
Meadox Surgimed, Inc.
Gastroenterology & Urology · 176d
Cleared Feb 11, 1987
WINDSOR SAFETY-TOP ENTERAL FEEDING BAG/BAG & SET
K864364 · KNT
Technical Associates of New England
Gastroenterology & Urology · 98d
Cleared Feb 10, 1987
3F ELECTRODE
K864904 · FFK
Northgate Research, Inc.
Gastroenterology & Urology · 57d
Cleared Feb 10, 1987
TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.
K864960 · GCQ
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 50d
Cleared Feb 06, 1987
THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM)
K864448 · KPN
Biosonics, Inc.
Gastroenterology & Urology · 86d
Cleared Feb 04, 1987
CHEMO-CATH INTRAPERITONEAL CATHETER
K863819 · FJS
Hdc Corp.
Gastroenterology & Urology · 127d
Cleared Feb 03, 1987
COOK-VPI CONTINENCE CUFF
K863227 · FHA
Cook Urological, Inc.
Gastroenterology & Urology · 166d
Cleared Jan 30, 1987
ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT
K864225 · FAD
Angiomed U.S., Inc.
Gastroenterology & Urology · 94d
Cleared Jan 20, 1987
UROCUT BIOPSY NEEDLE
K861267 · KNW
Meadox Surgimed, Inc.
Gastroenterology & Urology · 291d
Cleared Jan 20, 1987
SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS
K864784 · FJK
Cd Medical, Inc.
Gastroenterology & Urology · 43d
Cleared Jan 13, 1987
LUXTEC LIGHT SOURCES
K864385 · FCW
Luxtec Corp.
Gastroenterology & Urology · 69d
Cleared Jan 13, 1987
FOUR TANK DISSOLUTION MODULE
K864635 · FKQ
National Medical Care, Medical...
Gastroenterology & Urology · 49d
Cleared Jan 12, 1987
PROCON
K864218 · KNT
Healthcare Management Systems
Gastroenterology & Urology · 76d
Cleared Jan 05, 1987
AM CATH ESWL STENT
K864669 · FAD
Inter-Med Corp.
Gastroenterology & Urology · 34d
Cleared Dec 24, 1986
AKRO-SIL PLUS
K864736 · KOD
Akron Catheter, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 24, 1986
THE KEYMED HI-LIGHT 250 LIGHT SOURCE
K864801 · GCT
Keymed, Inc.
Gastroenterology & Urology · 15d
Cleared Dec 24, 1986
RADIOGRAPHIC - LEG SECTION
K864846 · KQS
American Sterilizer Co.
Gastroenterology & Urology · 14d