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
5833–5856 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 07, 1994
GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS
K933681 · FJG
Cobe Renal Care, Inc.
Gastroenterology & Urology · 405d
Cleared Sep 07, 1994
CONTINUOUS IRRIGATION CYSTOURETHROSCOPE
K935163 · FBO
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 313d
Cleared Sep 07, 1994
STONE EXTRACTOR, GRASPING FORCEPS
K935737 · FFL
Boston Scientific Corp
Gastroenterology & Urology · 280d
Cleared Aug 31, 1994
RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
K930843 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 559d
Cleared Aug 29, 1994
DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES
K923529 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 774d
Cleared Aug 29, 1994
HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
K931763 · FAS
Olympus Corp.
Gastroenterology & Urology · 508d
Cleared Aug 29, 1994
MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR
K943191 · LQC
Boston Scientific Corp
Gastroenterology & Urology · 55d
Cleared Aug 26, 1994
EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE)
K926218 · HIR
Sandhill Scientific, Inc.
Gastroenterology & Urology · 624d
Cleared Aug 26, 1994
GAMBRO LUNDIA PRO 200 DIALYZER
K933680 · FJG
Cobe Renal Care, Inc.
Gastroenterology & Urology · 393d
Cleared Aug 26, 1994
MDT UROLOGY TABLE
K942485 · MMZ
Mdt Corp., Inc.
Gastroenterology & Urology · 93d
Cleared Aug 26, 1994
LIVER BIOPSY KIT
K943650 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 25, 1994
RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM
K941781 · LIL
Dacomed Corp.
Gastroenterology & Urology · 136d
Cleared Aug 23, 1994
CLA-COMPUTERIZED LARYNGEAL ANALYZER
K922553 · KLA
H.I.L. Research, Ltd.
Gastroenterology & Urology · 816d
Cleared Aug 23, 1994
FRESENIUS HEMOFLOW, VARIOUS MODELS
K926005 · FJI
Fresenius USA, Inc.
Gastroenterology & Urology · 634d
Cleared Aug 22, 1994
STONE EXTRACTOR
K935721 · FFL
Boston Scientific Corp
Gastroenterology & Urology · 265d
Cleared Aug 19, 1994
MEDSURG INSERTION TRAY
K920780 · LFJ
Medsurg Industries, Inc.
Gastroenterology & Urology · 911d
Cleared Aug 19, 1994
BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER
K935045 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 302d
Cleared Aug 19, 1994
ENTRAC URETERAL BALLOON DILATATION CATHETERS
K942578 · EZN
American Medical Systems, Inc.
Gastroenterology & Urology · 80d
Cleared Aug 18, 1994
BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER
K910318 · MJC
C.R. Bard, Inc.
Gastroenterology & Urology · 1302d
Cleared Aug 18, 1994
MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM
K940838 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 176d
Cleared Aug 17, 1994
AMERICAN CATHETER E.R.C.P. CANNULA
K940370 · FGE
Intl. Medical, Inc.
Gastroenterology & Urology · 203d
Cleared Aug 17, 1994
MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE
K943737 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 15d
Cleared Aug 10, 1994
ELMED PNEUMOPERITONEUM NEEDLES
K943624 · FHO
Henke-Sass, Wolf GmbH
Gastroenterology & Urology · 15d
Cleared Aug 05, 1994
FILTRAL HEMODIALYZERS
K920757 · KDI
C.G.H. Medical, Inc.
Gastroenterology & Urology · 898d