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
6817–6840 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 20, 1990
FOLEY CATHETER INSERTION TRAY (10CC)
K901185 · FCM
Orion Life Systems, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 19, 1990
METRICARE ENTERAL FEEDING SYSTEM
K895923 · FPD
Metrix Co.
Gastroenterology & Urology · 281d
Cleared Jul 16, 1990
CLOSED DISCONNECT SYSTEM
K900106 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 188d
Cleared Jul 16, 1990
WILSON-COOK ESOPHAGEAL MOTILITY CATHETER
K900239 · KLA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 180d
Cleared Jul 16, 1990
GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER
K900918 · KDI
Gambro, Inc.
Gastroenterology & Urology · 139d
Cleared Jul 16, 1990
GASTROINTESTINAL CYTOLOGY BRUSH
K901435 · FDX
Telemed Systems, Inc.
Gastroenterology & Urology · 112d
Cleared Jul 16, 1990
WILSON-COOK SYRINGE HOLDERS
K902107 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 69d
Cleared Jul 16, 1990
BAG, URINE
K902417 · KNX
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 46d
Cleared Jul 16, 1990
MEADOX SURGIMED BIOPSY GUN AND NEEDLE
K902461 · KNW
Meadox Surgimed, Inc.
Gastroenterology & Urology · 42d
Cleared Jul 16, 1990
SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET
K902773 · FGB
Medical Engineering Corp.
Gastroenterology & Urology · 21d
Cleared Jul 13, 1990
MDL-2000 LASERTRIPTER
K901723 · LNK
Candela Laser Corp.
Gastroenterology & Urology · 88d
Cleared Jul 12, 1990
CN GAURD, STERILE LATEX SURGICAL GLOVES
K896322 · FGO
C.N. Technocrats
Gastroenterology & Urology · 253d
Cleared Jul 11, 1990
SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
K900341 · LIF
Serim Research Corp.
Gastroenterology & Urology · 170d
Cleared Jul 11, 1990
WET-NO-MORE MONITOR
K901906 · KPN
Travis Industries, Inc.
Gastroenterology & Urology · 75d
Cleared Jul 03, 1990
PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE
K900269 · FFL
Porges Corp.
Gastroenterology & Urology · 166d
Cleared Jul 02, 1990
P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY
K900884 · KGC
Applied Medical Technologies
Gastroenterology & Urology · 126d
Cleared Jul 02, 1990
GASTROINTESTINAL TUBES AND ACCESSORIES
K901023 · KNT
Medline Industries, Inc.
Gastroenterology & Urology · 119d
Cleared Jun 29, 1990
ACKRAD MPR DRAINAGE CATHETER SET
K901574 · KNT
Ackrad Laboratories
Gastroenterology & Urology · 87d
Cleared Jun 29, 1990
SULLIVAN VARIABLE STIFFNESS CABLE
K901610 · FDF
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 28, 1990
ENEMA BUCKET SET
K901179 · FCE
Orion Life Systems, Inc.
Gastroenterology & Urology · 107d
Cleared Jun 28, 1990
ENEMA BAG SET
K901182 · FCE
Orion Life Systems, Inc.
Gastroenterology & Urology · 107d
Cleared Jun 27, 1990
MAXX 470 CORE BIOPSY GUN
K900082 · KNW
Dlp, Inc.
Gastroenterology & Urology · 173d
Cleared Jun 27, 1990
EXTERNAL LEG BAG
K901219 · FAQ
Orion Life Systems, Inc.
Gastroenterology & Urology · 106d
Cleared Jun 27, 1990
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
K901482 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 90d