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
4873–4896 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 19, 1997
DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES
K973291 · FJI
Dynamic Technology Corp.
Gastroenterology & Urology · 108d
Cleared Dec 19, 1997
AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT...
K973893 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 66d
Cleared Dec 19, 1997
AMSURE CLEANSING ENEMA SET
K974042 · FCE
Amsino Intl., Inc.
Gastroenterology & Urology · 56d
Cleared Dec 19, 1997
HYDRA METER
K974127 · FIP
Automata Instrumentation, Inc.
Gastroenterology & Urology · 46d
Cleared Dec 19, 1997
TELEMED SYSTEMS RETRIEVAL BASKET
K974300 · OCZ
Telemed Systems, Inc.
Gastroenterology & Urology · 32d
Cleared Dec 18, 1997
BOUSER'S URINAL
K970465 · EXJ
General Polymers
Gastroenterology & Urology · 314d
Cleared Dec 18, 1997
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
K974164 · FFK
Medical Device Consultants, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 18, 1997
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
K974454 · OCT
Tucson Medical Corp.
Gastroenterology & Urology · 23d
Cleared Dec 15, 1997
COURIER ST BALLOON DILATATION CATHETER
K973008 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 124d
Cleared Dec 11, 1997
CRIT-LINE MONITOR (CLMIII)
K972470 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 163d
Cleared Dec 11, 1997
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
K972887 · KNX
Medline Industries, Inc.
Gastroenterology & Urology · 128d
Cleared Dec 11, 1997
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW...
K972979 · FBO
Smith & Nephew, Inc.
Gastroenterology & Urology · 122d
Cleared Dec 09, 1997
PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER
K972496 · KNW
Tao & Tao Technologyt, Inc.
Gastroenterology & Urology · 159d
Cleared Dec 09, 1997
ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
K974158 · KNW
Ortho Development Corp.
Gastroenterology & Urology · 36d
Cleared Dec 05, 1997
SPHINCTEROTOME
K973826 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 59d
Cleared Dec 03, 1997
S-357 VIDEO IMAGING SYSTEM
K973798 · FET
Sopro
Gastroenterology & Urology · 58d
Cleared Dec 02, 1997
SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
K973611 · FCL
Spectrascience, Inc.
Gastroenterology & Urology · 71d
Cleared Dec 01, 1997
INNOVASIVE DEVICES Y-KNOT SUTURE CLIP
K973313 · OCW
Innovasive Devices, Inc.
Gastroenterology & Urology · 89d
Cleared Dec 01, 1997
THE AUTO SUTURE* MIBB** SYSTEM
K973496 · KNW
United States Surgical, A Division of...
Gastroenterology & Urology · 77d
Cleared Nov 26, 1997
PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF,...
K964539 · FIP
Zyzatech Water Systems, Inc.
Gastroenterology & Urology · 379d
Cleared Nov 26, 1997
BODYSTAT
K971554 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 210d
Cleared Nov 26, 1997
BELZER-MPS
K972066 · KDN
Trans-Med Corp.
Gastroenterology & Urology · 176d
Cleared Nov 26, 1997
NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS
K972206 · KOC
Nipro Medical Corp.
Gastroenterology & Urology · 168d
Cleared Nov 26, 1997
COBRA HAND PIECE
K973366 · KNS
Vidamed, Inc.
Gastroenterology & Urology · 79d