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
5113–5136 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 11, 1997
HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
K960817 · MQS
Transonic Systems, Inc.
Gastroenterology & Urology · 349d
Cleared Feb 11, 1997
ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR...
K964561 · FDG
Bioenterics Corp.
Gastroenterology & Urology · 90d
Cleared Feb 10, 1997
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K946279 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 776d
Cleared Feb 10, 1997
LIBERTY RECTAL PELVIC FLOOR EXERCISER
K964526 · KPI
Utah Medical Products, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 07, 1997
KENDALL CURITY URETERAL CATHETER
K964899 · EYB
Kendall Healthcare Products Co....
Gastroenterology & Urology · 66d
Cleared Feb 07, 1997
RUSCH SUPRAPUBIC TRAY
K970021 · KOB
Rusch, Inc.
Gastroenterology & Urology · 35d
Cleared Feb 06, 1997
COBE HEMODYNAMIC RECIRCULATION MONITOR
K954003 · MQS
Cobe Renal Care, Inc.
Gastroenterology & Urology · 531d
Cleared Feb 04, 1997
MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP...
K962653 · FAS
Microgyn Corp.
Gastroenterology & Urology · 211d
Cleared Feb 04, 1997
SYMPACATH HYDROGEL COATED FOLEY
K964575 · EZL
Rusch Intl.
Gastroenterology & Urology · 82d
Cleared Feb 04, 1997
FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
K964892 · FJL
Gynecare Innovation Center
Gastroenterology & Urology · 60d
Cleared Jan 30, 1997
CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS
K964041 · KOC
Robert R. Stevens
Gastroenterology & Urology · 114d
Cleared Jan 29, 1997
PH ANALYSIS MODULE
K961346 · FFT
Synectics-Dantec
Gastroenterology & Urology · 320d
Cleared Jan 29, 1997
WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE
K961897 · FCG
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 258d
Cleared Jan 28, 1997
DILATION CATHETER, BALLOON
K965067 · GBM
Boston Scientific Corp
Gastroenterology & Urology · 41d
Cleared Jan 24, 1997
FLEXIBLE URETEROSCOPE
K964482 · FGB
Applied Fiberoptics, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 24, 1997
INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL...
K964577 · KPI
Empi
Gastroenterology & Urology · 71d
Cleared Jan 24, 1997
A LITHOTRIPTER-COMPATIBLE BASKET
K964937 · LQC
Boston Scientific Corp
Gastroenterology & Urology · 45d
Cleared Jan 17, 1997
PRESCOTT'S LIGHT SOURCE MODEL NO. II-150
K964586 · FCW
Iba/Griffith
Gastroenterology & Urology · 63d
Cleared Jan 16, 1997
PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
K960508 · HIR
The Prometheus Group
Gastroenterology & Urology · 346d
Cleared Jan 10, 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE...
K955384 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 415d
Cleared Jan 10, 1997
BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
K963950 · EXI
Bioderm, Inc.
Gastroenterology & Urology · 100d
Cleared Jan 10, 1997
CAP-AID (IMPROVED)
K964580 · FHA
Nebel, Inc.
Gastroenterology & Urology · 56d
Cleared Jan 08, 1997
CELL RECOVERY SYSTEM
K965037 · FDX
Medical Device Technologies, Inc.
Gastroenterology & Urology · 22d
Cleared Jan 03, 1997
VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH...
K964326 · FAM
Vision-Sciences, Inc.
Gastroenterology & Urology · 65d