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
9073–9096 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 20, 1981
DISPOSABLE URINE GAB-70.XX
K812251 · KNX
Manfred Sauer Corp.
Gastroenterology & Urology · 9d
Cleared Aug 20, 1981
LATEX LEG BAG-57.XX
K812252 · KNX
Manfred Sauer Corp.
Gastroenterology & Urology · 9d
Cleared Aug 13, 1981
ESOPHAGEAL MOTILITY PROBE
K811083 · FFT
Konigsberg Instruments, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 13, 1981
ESOPHAGEAL MOTILITY APPARATUS
K812103 · FFX
Honeywell, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 13, 1981
LIFE-TECH #'S 1106/1156 UROLABS
K812178 · FAP
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 10d
Cleared Aug 07, 1981
BACTASHIELD
K811859 · FIB
Tri-Med, Inc.
Gastroenterology & Urology · 37d
Cleared Aug 04, 1981
ISOLATER THP
K811981 · KOC
Tri-Med, Inc.
Gastroenterology & Urology · 22d
Cleared Jul 31, 1981
D-3160 SORBENT CARTRIDGE
K811170 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 94d
Cleared Jul 31, 1981
HEMASITE VASCULAR ACCESS SHUNT
K811384 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 73d
Cleared Jul 31, 1981
CORDIS DOW SERA FLO TM TRANSDUCER PROT
K811892 · FIB
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Jul 31, 1981
FORDER RETRACTOR
K811973 · KOA
Surgemed Marketing, Inc.
Gastroenterology & Urology · 21d
Cleared Jul 31, 1981
HEMASITE ACCESS MONITOR (TENT.) #RS-8200
K811977 · KOC
Renal Systems, Inc.
Gastroenterology & Urology · 18d
Cleared Jul 31, 1981
VANCE CYSTOSCOPIC
K812057 · FBK
Vance Products, Inc.
Gastroenterology & Urology · 10d
Cleared Jul 31, 1981
AKRON URINARY DRAINAGE BAT
K812058 · KNX
Latex Ind., Inc.
Gastroenterology & Urology · 10d
Cleared Jul 20, 1981
CATH-DAP
K811277 · KOD
Northwest Alabama Urological Assoc.
Gastroenterology & Urology · 73d
Cleared Jul 15, 1981
ENTRI ENTERNAL FEEDING SET
K811683 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 13, 1981
ROSS-EMERSON PUMP, MODEL 55-R
K811779 · KQT
J. H. Emerson Co.
Gastroenterology & Urology · 20d
Cleared Jul 10, 1981
MGN FEEDING TUBE
K811533 · KNT
Mgn Medical Manufacturing, Inc.
Gastroenterology & Urology · 39d
Cleared Jul 10, 1981
GAMBRO WATER PURIFICATION MONITOR WRD
K811678 · FIP
Gambro, Inc.
Gastroenterology & Urology · 25d
Cleared Jul 10, 1981
VNACE FASCIAL DILATOR SET
K811833 · KOE
Vance Products, Inc.
Gastroenterology & Urology · 10d
Cleared Jul 01, 1981
DENVER PERITONEO-VENOUS SHUNT
K811183 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 63d
Cleared Jun 26, 1981
SUCTION WOUND DRAINAGE DEVICE
K810739 · KQT
The Urology Group
Gastroenterology & Urology · 99d
Cleared Jun 26, 1981
GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET
K811580 · FFL
Porges Catheter Corp.
Gastroenterology & Urology · 21d
Cleared Jun 26, 1981
ETHIX FEEDING TUBES POLYURETHANE/RADIOP.
K811639 · KNT
Ethox Corp.
Gastroenterology & Urology · 16d