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
5401–5424 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 29, 1995
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · FIP
Fresenius USA, Inc.
Gastroenterology & Urology · 428d
Cleared Nov 29, 1995
BLADE, SCALPEL & BLADE, HANDEL
K954536 · OCZ
Access Surgical Intl., Inc.
Gastroenterology & Urology · 61d
Cleared Nov 22, 1995
XCHF-33 CHOLEDOCHOFIBERSCOPE
K944473 · FBN
Olympus America, Inc.
Gastroenterology & Urology · 439d
Cleared Nov 22, 1995
RESECTOSCOPES
K954050 · FJL
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 85d
Cleared Nov 21, 1995
LOW PROFILE CATHETER
K922567 · KNT
Rusch, Inc.
Gastroenterology & Urology · 1268d
Cleared Nov 21, 1995
CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS
K946109 · KNS
Cabot Medical Corp.
Gastroenterology & Urology · 342d
Cleared Nov 21, 1995
DANTEC DA CAPO
K953999 · EXY
Dantec Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Nov 17, 1995
TS 564/PF
K950247 · FJK
Bressler, Amery & Ross
Gastroenterology & Urology · 301d
Cleared Nov 16, 1995
GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER,...
K951421 · FCG
Global Medical Products, Ltd.
Gastroenterology & Urology · 233d
Cleared Nov 14, 1995
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)
K954734 · FET
The Tulip Mfg. Co.
Gastroenterology & Urology · 42d
Cleared Nov 06, 1995
SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP
K954116 · FEW
Technical Products, Inc.
Gastroenterology & Urology · 109d
Cleared Nov 03, 1995
FCP-9P, FIBER CHOLEDOCHOSCOPE
K953286 · FBN
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 113d
Cleared Nov 03, 1995
STERILE FEEDING TUBE
K954218 · FPD
Baxter Healthcare Corp
Gastroenterology & Urology · 56d
Cleared Oct 31, 1995
MITEK MINI ANCHOR
K936311 · MNV
Mitek Surgical Products, Inc.
Gastroenterology & Urology · 559d
Cleared Oct 30, 1995
NEEDLE OR CUTTER
K953399 · KNW
Biophysic Medical, Inc.
Gastroenterology & Urology · 102d
Cleared Oct 30, 1995
PEDIATRIC EUROPHYLIC FOLEY CATHETER
K954752 · EZL
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 27, 1995
DUNA II PENILE PROSTHESIS
K953640 · FAE
Dacomed Corp.
Gastroenterology & Urology · 84d
Cleared Oct 26, 1995
FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC
K954377 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 37d
Cleared Oct 24, 1995
MITEK ABSORBABLE ANCHOR
K941599 · MNV
Mitek Surgical Products, Inc.
Gastroenterology & Urology · 571d
Cleared Oct 23, 1995
KSEA REVERSE VIDEO
K952482 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 146d
Cleared Oct 23, 1995
MEHTA BRONCHIAL BIOSPY DRILL
K954693 · FCK
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 12d
Cleared Oct 19, 1995
XENON NOPPVA
K954561 · GCT
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 17d
Cleared Oct 17, 1995
INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC
K930530 · KPI
Hollister, Inc.
Gastroenterology & Urology · 987d
Cleared Oct 17, 1995
URODYNAMICS TUBING AND INFUSION SETS
K954341 · FEN
Life-Tech Intl., Inc.
Gastroenterology & Urology · 29d