FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Gastroenterology & Urology ×
9,917 results
7345–7368 of 9,917
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 12, 1988
TONOMITOR (TM) + SUMP
K883234 · FFT
Tonometrics, Inc.
Gastroenterology & Urology · 72d
Cleared Oct 12, 1988
CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT
K883307 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 69d
Cleared Oct 12, 1988
LAKE FOLEY CATHETERIZATION TRAY
K883610 · FCN
Lake Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Sep 29, 1988
DRY COMFORT UNDERGARMENT
K882418 · EYQ
Health Tec, Inc.
Gastroenterology & Urology · 108d
Cleared Sep 29, 1988
MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND
K883023 · GDS
Mentor Corp.
Gastroenterology & Urology · 72d
Cleared Sep 29, 1988
BARD BIOPSY NEEDLE GUIDANCE DEVICE
K883374 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 51d
Cleared Sep 29, 1988
ACCUFLO UF CONTROL MODULE NO. 74-0100-3
K883490 · FJB
National Medical Care, Medical...
Gastroenterology & Urology · 44d
Cleared Sep 29, 1988
GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER
K883589 · FJI
Gambro, Inc.
Gastroenterology & Urology · 38d
Cleared Sep 21, 1988
CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
K882867 · KNT
Corpak Co.
Gastroenterology & Urology · 72d
Cleared Sep 15, 1988
COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS
K881811 · FJI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 140d
Cleared Sep 14, 1988
LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
K870722 · FJK
National Medical Care, Medical...
Gastroenterology & Urology · 587d
Cleared Sep 14, 1988
MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS
K881478 · KNQ
Keymed (Medical & Industrial...
Gastroenterology & Urology · 161d
Cleared Sep 13, 1988
MRM GASTROSTOMY BELT
K882089 · KNT
Mrm Products, Inc.
Gastroenterology & Urology · 117d
Cleared Sep 13, 1988
COMPAT (R) ENTERAL DELIVERY SYSTEM
K882218 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 110d
Cleared Sep 13, 1988
FILLING VOLUME OPTION
K882295 · LJH
Eris Medical Technology
Gastroenterology & Urology · 103d
Cleared Sep 13, 1988
FRESENIUS F8 DIALYZER
K883195 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 47d
Cleared Sep 12, 1988
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469 · FER
Baxter Healthcare Corp
Gastroenterology & Urology · 158d
Cleared Aug 30, 1988
ANOTRON(R) INCONTINENCE CONTROL SYSTEM
K882555 · KPN
Biosonics, Inc.
Gastroenterology & Urology · 70d
Cleared Aug 24, 1988
GAMBRO MULTIPURPOSE SYSTEM MPS-10
K881270 · FII
Gambro, Inc.
Gastroenterology & Urology · 153d
Cleared Aug 23, 1988
GASTROSTOMY FEEDING TUBE
K883336 · KNT
Gastrotech, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 23, 1988
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE
K883351 · KNT
Gastrotech, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 12, 1988
KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH
K881667 · GBM
The Kendal Co.
Gastroenterology & Urology · 116d
Cleared Aug 12, 1988
MODIFIED TORAY FILTRYZER DIALYZERS
K882158 · FJI
Toray Industries (America), Inc.
Gastroenterology & Urology · 81d
Cleared Aug 11, 1988
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.
K880581 · FFX
Synectics-Dantec
Gastroenterology & Urology · 183d