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
8785–8808 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 14, 1983
EXTRACORPOREAL SUBCLAVIAN CATHETER KIT
K823752 · FIQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 31d
Cleared Jan 14, 1983
A.V. FISTULA CANNULATION SETS
K830021 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 10d
Cleared Jan 12, 1983
LUNDIA 10-5-L PARRALLE FLOW DIALYZER
K823791 · KOC
Gambro, Inc.
Gastroenterology & Urology · 27d
Cleared Jan 12, 1983
CAPILLARY FLOW DIALYZERS
K823826 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Jan 09, 1983
CATHETER HOLDER
K823818 · KOD
Danek Medical, Inc.
Gastroenterology & Urology · 23d
Cleared Jan 07, 1983
COBE HEMOCONCENTRATOR 1.3
K823338 · KDI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 60d
Cleared Jan 07, 1983
URETHRAL PRESSURE PROFILE & TEMP. MODUL
K823561 · FAP
Nihon Kohden America, Inc.
Gastroenterology & Urology · 36d
Cleared Jan 07, 1983
STERILE, DISPOS. SPIKE PROTECTOR-5C4138
K823777 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Jan 07, 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K823778 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Jan 05, 1983
HOSPAL BLOOD LINES
K823707 · KOC
Hospal Medical Corp.
Gastroenterology & Urology · 27d
Cleared Dec 28, 1982
PEDIATRIC URINE COLLECTOR
K823411 · KNX
Sage Products, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 28, 1982
FEMALE EXTERNAL URINARY APPLIANCE
K823450 · KNX
Diamed Division Ill. Tool Works, Inc.
Gastroenterology & Urology · 41d
Cleared Dec 22, 1982
H 12 07
K823589 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 16d
Cleared Dec 16, 1982
AMICON DIAFILTERS 20 & 30 HEMOFILTERS
K823288 · KDI
Amicon, Inc.
Gastroenterology & Urology · 42d
Cleared Dec 16, 1982
RENAFLO II
K823546 · KOC
Renal Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Dec 13, 1982
UROCOMP REMOTE CONTROL 1804
K822916 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 73d
Cleared Dec 07, 1982
UNI-TIP COLOSTOMY IRRIGATION CONE
K823274 · EXD
Howmedica Corp.
Gastroenterology & Urology · 34d
Cleared Dec 07, 1982
NEPHROSS, ANDANTE H.F.
K823375 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 25d
Cleared Dec 03, 1982
1424 TUMISTORE
K822914
Life-Tech Intl., Inc.
Gastroenterology & Urology · 63d
Cleared Dec 03, 1982
GASTRIC LAVAGE KIT
K823195 · KNT
Autovage
Gastroenterology & Urology · 38d
Cleared Dec 03, 1982
HEYER-SCHUTE UNIVERSAL URETERAL STENT
K823418 · LJE
American Hospital Supply Corp.
Gastroenterology & Urology · 18d
Cleared Nov 30, 1982
RIGHT ATRIAL CATHETER
K822964 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 56d
Cleared Nov 30, 1982
INPERSOL PERITONEAL DIALSIS CYCLER SET
K823217 · FKX
Abbott Laboratories
Gastroenterology & Urology · 33d
Cleared Nov 30, 1982
1512M/F WIRE ELECTRODE NEEDLE SET
K823432 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 14d