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
8113–8136 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 12, 1985
MNI 400 INJECTION CAPS
K852162 · LFJ
Med-West, Inc.
Gastroenterology & Urology · 23d
Cleared Jun 12, 1985
JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT
K852297 · EXB
Johnson & Johnson Professionals, Inc.
Gastroenterology & Urology · 14d
Cleared Jun 04, 1985
FLEXIBLE FIBEROPTIC ENDOSCOPE
K850393
Microvasive
Gastroenterology & Urology · 123d
Cleared Jun 04, 1985
SARTORIUS AQUASART SM 40035 - DIALYSATE SYS
K850435 · FKR
Sartorius Filters, Inc.
Gastroenterology & Urology · 120d
Cleared May 23, 1985
RENAFLO HEMOCONCENTRATOR
K844790 · KDI
Renal Systems, Inc.
Gastroenterology & Urology · 164d
Cleared May 23, 1985
DISPOSABLE UROSTOMY POUCH
K850750 · EXB
Biolog, Inc.
Gastroenterology & Urology · 87d
Cleared May 23, 1985
DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY
K850751 · EXB
Biolog, Inc.
Gastroenterology & Urology · 87d
Cleared May 23, 1985
BARD PERISTOMAL PASTE
K851398 · EXB
C.R. Bard, Inc.
Gastroenterology & Urology · 44d
Cleared May 23, 1985
OLBERT CATHETER SYS FOR URETERAL DILATION
K851463 · EZN
Meadox Surgimed, Inc.
Gastroenterology & Urology · 38d
Cleared May 23, 1985
OMNIMED SUPERIOR TRANSDUCER PROTECTOR
K851734 · FIB
Omni Intl., Inc.
Gastroenterology & Urology · 28d
Cleared May 23, 1985
53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH
K851797 · FFQ
Artiberia
Gastroenterology & Urology · 28d
Cleared May 23, 1985
53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN
K851798 · KNW
Artiberia
Gastroenterology & Urology · 28d
Cleared May 22, 1985
HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM
K851096 · KNS
Olympus Corp.
Gastroenterology & Urology · 64d
Cleared May 21, 1985
TRANDUCER PROTECTOR
K851428 · FIB
Galvin Industries, Inc.
Gastroenterology & Urology · 41d
Cleared May 17, 1985
ALCIDE REN NEW-D
K844734 · FKQ
Alcide Corp.
Gastroenterology & Urology · 164d
Cleared May 17, 1985
WSP CODE 4310 STRESSCATH
K850694 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 85d
Cleared May 17, 1985
WSP CODE 4300 DIOMASTER DIAGNOSTIC
K850696 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 85d
Cleared May 17, 1985
MANAN GREENE NEEDLE
K851835 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 19d
Cleared May 16, 1985
GAMBRO PLASMAFILTRATION SYSTEM
K850621 · LKN
Gambro, Inc.
Gastroenterology & Urology · 90d
Cleared May 16, 1985
WSP CODE 4301 DIOMASTER THERAPEUTIC
K850695 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 84d
Cleared May 14, 1985
MANAN FRANSEENE NEEDLE
K851831 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 18d
Cleared May 14, 1985
MANAN WESTCOTT NEEDLE
K851837 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 18d
Cleared May 10, 1985
WSP CODE 4315 PADTEST
K850693 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 78d
Cleared May 10, 1985
KEITH-A.R.V.
K851444 · KNT
Karl M. Block Co.
Gastroenterology & Urology · 29d