FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Gastroenterology & Urology ×
9,917 results
8473–8496 of 9,917
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 20, 1984
CHEMLYTE
K834395 · FKQ
Diachem Laboratories
Gastroenterology & Urology · 128d
Cleared Apr 20, 1984
DRAINAGE STENT
K834468 · FGE
Microvasive
Gastroenterology & Urology · 122d
Cleared Apr 20, 1984
REAL FIBER OPTIC URETERAL TRANSILLUMIN
K834576 · FFS
Douglas Manufacturer Co.
Gastroenterology & Urology · 113d
Cleared Apr 20, 1984
HEMOCATH
K840415 · FIQ
Quinton, Inc.
Gastroenterology & Urology · 80d
Cleared Apr 20, 1984
CENTRY 2000 DIALYSIS CONTROL UNIT
K840680 · KDI
Cobe Laboratories, Inc.
Gastroenterology & Urology · 65d
Cleared Apr 20, 1984
TOPS DISPOS. INFUSION SET/HEMODIALYSIS
K841119 · KNZ
Top Surgical Manufacturers Co.
Gastroenterology & Urology · 36d
Cleared Apr 20, 1984
DIALYSIS TRAY
K841124 · KOC
Medcare Products
Gastroenterology & Urology · 36d
Cleared Apr 17, 1984
MMG FOLEY CATHETER
K840839 · KOD
Medical Technologies of Georgia
Gastroenterology & Urology · 53d
Cleared Apr 13, 1984
HEMODIAL CONCENTRATE
K834587 · FKQ
Moana Productions, Inc.
Gastroenterology & Urology · 106d
Cleared Apr 13, 1984
MULTIPLE BAG, LEG
K840283 · KNX
Luth Corp.
Gastroenterology & Urology · 86d
Cleared Apr 13, 1984
MULTIPLE SYS-URINE DRAINAGE-CLOSED
K840284 · KNX
Luth Corp.
Gastroenterology & Urology · 86d
Cleared Apr 13, 1984
LABORIE FIBREOPTIC LIGHT CABLE
K840605 · FFS
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 63d
Cleared Apr 13, 1984
URETERAL DILATOR
K840746 · KOE
American Edwards Laboratories
Gastroenterology & Urology · 85d
Cleared Apr 13, 1984
AMBEZE DISPOSABLE INCONTINENCE PANTS
K840753 · EYQ
Ipco Corp.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1984
MAXISHIELD INCONTINENCE CARE SYSTEM
K840754 · EYQ
Ipco Corp.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1984
MINIGARD DISPOSABLE LINERS
K840755 · EYQ
Ipco Corp.
Gastroenterology & Urology · 50d
Cleared Apr 13, 1984
BIOPSY FORCEPS
K840818 · FCL
American Endoscopy, Inc.
Gastroenterology & Urology · 49d
Cleared Apr 13, 1984
MILLER-ABBOTT TUBE
K841033 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 13, 1984
DEAVER T-DRAIN & CATTEL T-DRAIN
K841034 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 13, 1984
ULTRA BAKER JEJUNOSTOMY TUBE
K841035 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 13, 1984
RECTAL BALLOON CATHETERS
K841036 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 13, 1984
BLAKEMORE TUBE
K841038 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 13, 1984
CANTOR TUBE
K841039 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 05, 1984
USCI ENDOPROSTHESIS
K834574 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 98d