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
8833–8856 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 13, 1982
SAFE LOCK SEALING CAP L
K822544 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 13, 1982
CCPD CYCLER SET W/5 PRONGED CONNECTOR
K822545 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 13, 1982
SAFE LOCK SEALING CAPS
K822546 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 13, 1982
SAFE LOCK CATHETER S-3
K822548 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 13, 1982
CCPD CYCLER SET W/5 PRONGED SAFE LOCK
K822549 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 13, 1982
SAFE LOCK TITANIUM ADAPTER SET
K822550 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 13, 1982
AMP CAPD UNISPIKE AMINISTRATION SET
K822551 · FKK
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 13, 1982
PEDI-TUBE PEDIATRIC FEEDING TUBE
K822875 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 16d
Cleared Oct 06, 1982
COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA
K822386 · FII
Hospal Medical Corp.
Gastroenterology & Urology · 58d
Cleared Oct 04, 1982
DISSCAP 080
K822851 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 10d
Cleared Sep 28, 1982
NEEDLE CATHETER JEJUNOSTOMY KIT
K822565 · KNT
Bio-Research Associates, Inc.
Gastroenterology & Urology · 37d
Cleared Sep 28, 1982
LITHOTRIPTOR ELECTRODE 4.5F
K822585 · FFK
Monaghan Medical Corp.
Gastroenterology & Urology · 33d
Cleared Sep 24, 1982
RETRIEVAL BALLOONS
K821818 · KOD
American Endoscopy, Inc.
Gastroenterology & Urology · 95d
Cleared Sep 24, 1982
THERMOTHERAPY
K822217 · LKX
Luther Medical Products, Inc.
Gastroenterology & Urology · 60d
Cleared Sep 24, 1982
ADHESIVE SPRAY #4050-4060
K822307 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 52d
Cleared Sep 24, 1982
TRIEX-IH DIALYZER
K822738 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 15d
Cleared Sep 24, 1982
SOLID STATE CONTINUOUS FLOW CONTROL
K822743 · LJH
Widran Urological Group, Ltd.
Gastroenterology & Urology · 14d
Cleared Sep 21, 1982
RIWOLITH 2135
K822644 · FFK
R. Wolf Medical Instruments Corp.
Gastroenterology & Urology · 20d
Cleared Sep 21, 1982
DENVER PERITONEO-VENOUS SHUNT (DP-VS)
K822686 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 18d
Cleared Sep 17, 1982
ROMBEAU GASTROSTOMY-JEJUNAL TUBE
K822380 · KNT
Hedeco
Gastroenterology & Urology · 39d
Cleared Sep 09, 1982
AUTOMATIC SPLICING DEVICE
K822025 · FKX
E.I. Dupont DE Nemours & Co., Inc.
Gastroenterology & Urology · 59d
Cleared Sep 09, 1982
GASTRO VAGE SET FOR GASTRIC LAVAGE
K822228 · KNT
Ackrad Laboratories
Gastroenterology & Urology · 44d
Cleared Sep 09, 1982
CAPD BELT
K822547 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 16d
Cleared Sep 09, 1982
ARGYLE DUO-TUBE
K822631 · KNT
Sherwood Medical Co.
Gastroenterology & Urology · 9d