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
5017–5040 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 13, 1997
HBF-1000 OMRON BODY COMPOSITION ANALYZER
K963575 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 280d
Cleared Jun 13, 1997
SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT
K971230 · KNT
Innerdyne, Inc.
Gastroenterology & Urology · 72d
Cleared Jun 11, 1997
ASPISAFE GASTRIC TUBE
K961711 · BSS
B.Braun Medical, Inc.
Gastroenterology & Urology · 405d
Cleared Jun 10, 1997
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
K970946 · LJH
Medline Industries, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 06, 1997
ANOKRYO
K964634 · FFP
Mk Conquest Intl., Inc.
Gastroenterology & Urology · 199d
Cleared Jun 05, 1997
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
K963064 · FFX
Laborie Medical Tech Corp.
Gastroenterology & Urology · 302d
Cleared Jun 03, 1997
LUMAX CYSTOMETRY ADMINISTRATION TUBE SET
K971911 · FEN
Medamicus, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 02, 1997
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
K970446 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 117d
Cleared May 28, 1997
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
K970526 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 106d
Cleared May 27, 1997
COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY,...
K971202 · OCZ
Comeg Endoskopie GmbH
Gastroenterology & Urology · 56d
Cleared May 27, 1997
LSVP INTERNATIONAL HOT BIOPSY FORCEPS
K971204 · KGE
Lsvp Intl., Inc.
Gastroenterology & Urology · 56d
Cleared May 23, 1997
RUSCH ENTERAL FEEDING TUBE
K963779 · FPD
Rusch, Inc.
Gastroenterology & Urology · 245d
Cleared May 23, 1997
BETTER-BLADDER (BB)
K964337 · FIB
Circulatory Technology, Inc.
Gastroenterology & Urology · 204d
Cleared May 23, 1997
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
K970077 · KPI
Utah Medical Products, Inc.
Gastroenterology & Urology · 134d
Cleared May 23, 1997
#ES-32 SUCTION CATHETER 32 FR.
K970890 · KNT
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 73d
Cleared May 23, 1997
ENDO SMARTCAP (100501)
K971125 · OCX
Endo Smart Cap Co.
Gastroenterology & Urology · 57d
Cleared May 23, 1997
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
K971275 · FDI
Mill-Rose Laboratory
Gastroenterology & Urology · 46d
Cleared May 23, 1997
CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
K971584 · OCV
Clarus Medical Systems, Inc.
Gastroenterology & Urology · 23d
Cleared May 21, 1997
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K963254 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 275d
Cleared May 21, 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE...
K964922 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 163d
Cleared May 21, 1997
TR NEEDLE
K970871 · KNW
Gallini Intl., Inc.
Gastroenterology & Urology · 72d
Cleared May 21, 1997
PAN (CHIBA ASPIRATING NEEDLE)
K970872 · KNW
Gallini Intl., Inc.
Gastroenterology & Urology · 72d
Cleared May 20, 1997
UROSTYM
K962009 · KPI
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 363d
Cleared May 20, 1997
ULTRAFLEX DIAMOND
K962899 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 299d