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
8809–8832 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 29, 1982
RAAF DUAL LUMEN CATHETER
K822849
Quinton, Inc.
Gastroenterology & Urology · 67d
Cleared Nov 29, 1982
RIGHT ARTERIAL CATHETER
K822910 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 59d
Cleared Nov 24, 1982
BED GUARD
K823276 · KPN
T. S. Enterprises, Inc.
Gastroenterology & Urology · 21d
Cleared Nov 22, 1982
HEMAFLO BLOOD TUBING SETS
K823092 · FKQ
Cobe Laboratories, Inc.
Gastroenterology & Urology · 33d
Cleared Nov 17, 1982
DIA SCOPE
K822087 · KNT
Exitec, Inc.
Gastroenterology & Urology · 127d
Cleared Nov 17, 1982
SIGMOIDOSCOPE, FLEXIBLE
K822765 · FAM
Harvard Laboratories
Gastroenterology & Urology · 64d
Cleared Nov 16, 1982
ENTERAL NUTRITION 1
K822879 · KNT
Exco, Inc.
Gastroenterology & Urology · 50d
Cleared Nov 16, 1982
TRAVASORB NASOGASTRIC NASOINTESTINAL
K823082 · KNT
Travenol Laboratories, S.A.
Gastroenterology & Urology · 27d
Cleared Nov 08, 1982
REXTON
K823075
Argosy Intl. (Usa), Inc.
Gastroenterology & Urology · 20d
Cleared Nov 03, 1982
EXTRACORPOREAL SINGLE NEEDLE MODULE
K822340 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 91d
Cleared Nov 03, 1982
DEVICE FOR THE TREATMENT OF HEMORRHOIDS
K822649 · LKX
Dunmore Corp.
Gastroenterology & Urology · 63d
Cleared Nov 03, 1982
ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL
K822711 · FAX
Parker Laboratories, Inc.
Gastroenterology & Urology · 57d
Cleared Oct 22, 1982
MODEL 700 GASTROREFLUX MONITOR/AMALYZER
K822815 · FFT
Del Mar Avionics
Gastroenterology & Urology · 32d
Cleared Oct 22, 1982
PENTAX FC-38LA & FC-38SA COLONOFIBER
K822846 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 29d
Cleared Oct 22, 1982
ENDOSCOPIC VIDEOSYSTEM
K822959 · FET
Eder Instrument Co, Inc.
Gastroenterology & Urology · 17d
Cleared Oct 21, 1982
EXTENSION SET TYPE DP
K822658 · FKX
Abbott Laboratories
Gastroenterology & Urology · 48d
Cleared Oct 21, 1982
INPERSOL-CAPD ADMINIS. SET TYPE DP
K822712 · FKX
Abbott Laboratories
Gastroenterology & Urology · 44d
Cleared Oct 20, 1982
FACE SHIELDS
K822004 · KNT
Kelleher Corp.
Gastroenterology & Urology · 104d
Cleared Oct 18, 1982
DIALYZER REPROCESSING SYSTEM DRS-4
K821863 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 116d
Cleared Oct 18, 1982
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K822796 · KOC
Erika, Inc.
Gastroenterology & Urology · 32d
Cleared Oct 18, 1982
ARTERIO VENOUS SHUNT CANNULA & ADAPTORS
K822880 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 27d
Cleared Oct 13, 1982
TRANSFORMER
K822267
Kelleher Corp.
Gastroenterology & Urology · 76d
Cleared Oct 13, 1982
EXTRAPURE REVERSE OSMOSIS WATER UNIT
K822385 · FIP
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 65d
Cleared Oct 13, 1982
CAPD SAFE LOCK TRANSFER SET
K822543 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 51d