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
8713–8736 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 09, 1983
ENTERAL PUMP SET
K831167 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 28d
Cleared May 09, 1983
ENTERAL DELIVERY SET
K831168 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 28d
Cleared May 05, 1983
URINARY DIVERSION STENT
K830803 · LJE
Van-Tec, Inc.
Gastroenterology & Urology · 52d
Cleared Apr 28, 1983
HEMO-PROCESSING SYSTEM
K830487 · KDI
Sartorius Filters, Inc.
Gastroenterology & Urology · 72d
Cleared Apr 28, 1983
MONITRAL
K830595 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 63d
Cleared Apr 28, 1983
LOOP RETRIEVER
K830802 · OCZ
Van-Tec, Inc.
Gastroenterology & Urology · 45d
Cleared Apr 28, 1983
ASEPTIC FLUID TRANSFER SYSTEM
K830811 · KQQ
Steridoc Corp.
Gastroenterology & Urology · 44d
Cleared Apr 28, 1983
MALE EXTERNAL CATHETER
K830946 · KNX
Post Medical, Inc.
Gastroenterology & Urology · 35d
Cleared Apr 28, 1983
CURITY LEG BAG
K831121 · KNX
The Kendal Co.
Gastroenterology & Urology · 23d
Cleared Apr 28, 1983
TOP-FILL BAG
K831169 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 17d
Cleared Apr 27, 1983
ULTRAFILTRATION MONITOR UFM-10-2
K830596 · KDI
Gambro, Inc.
Gastroenterology & Urology · 62d
Cleared Apr 18, 1983
CRM-114 COLOR VIDEO CAMERA
K830924 · FET
Umi, Inc.
Gastroenterology & Urology · 27d
Cleared Apr 18, 1983
ENTERAL SOLUTION ADMIN. PUMP SET
K830965 · KNT
Corpak Co.
Gastroenterology & Urology · 21d
Cleared Apr 12, 1983
INFLATABLE PENILE PROSTH. - CYLINDER
K830048 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 92d
Cleared Apr 12, 1983
N.E.W. NEB
K830527
San Diego Plastics, Inc.
Gastroenterology & Urology
Cleared Apr 12, 1983
BLOOD LINE SETS FOR HEMOFILTRATION
K830677 · FJK
Gambro, Inc.
Gastroenterology & Urology · 39d
Cleared Apr 12, 1983
ASAHI BLOOD/PLASMA PUMP #ABP-01A &
K830818 · FIR
Parker Hannifin Corp.
Gastroenterology & Urology · 28d
Cleared Apr 12, 1983
SURGITEK SIZER FOR PENILE PROSTHESIS
K830917 · FAE
Medical Engineering Corp.
Gastroenterology & Urology · 21d
Cleared Apr 12, 1983
SUR-FIT FLEXIBLE
K830945 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 19d
Cleared Apr 06, 1983
SYN-02 PN AMPLIFIER
K830421 · FFX
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 06, 1983
COBE RX METER
K830629 · FLB
Cobe Laboratories, Inc.
Gastroenterology & Urology · 36d
Cleared Apr 06, 1983
OPEN ENDED URETERAL CATHETER
K830840 · GBM
Van-Tec, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 06, 1983
LUNDIA 10-2-N PARALLEL FLOW DIALYZER
K830905 · KOC
Gambro, Inc.
Gastroenterology & Urology · 16d
Cleared Mar 31, 1983
ERG-JET ELECTRODE
K830557 · HLZ
Universo S.A.
Gastroenterology & Urology · 36d