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
6961–6984 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 06, 1990
MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
K900031 · KNY
Porges Corp.
Gastroenterology & Urology · 61d
Cleared Mar 02, 1990
DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1
K900005 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 59d
Cleared Feb 27, 1990
QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3
K896956 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 75d
Cleared Feb 27, 1990
CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3
K900004 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 56d
Cleared Feb 27, 1990
CATHETER ADAPTER SEALING CAP NO. 48-1028-9
K900006 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 56d
Cleared Feb 26, 1990
4 SURE EXTERNAL MALE CATHETER
K896726 · KOD
The Boston & Pacific Co., Inc.
Gastroenterology & Urology · 89d
Cleared Feb 26, 1990
TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1
K896761 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 87d
Cleared Feb 26, 1990
CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1
K896763 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 87d
Cleared Feb 26, 1990
UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5
K896764 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 87d
Cleared Feb 26, 1990
CATHETER PLUG/PROTECTOR
K896806 · KNY
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 87d
Cleared Feb 20, 1990
4 SURE URINARY DRAIN BAG
K896727 · KNX
The Boston & Pacific Co., Inc.
Gastroenterology & Urology · 83d
Cleared Feb 20, 1990
4 SURE URINARY LEG BAG
K896728 · FAQ
The Boston & Pacific Co., Inc.
Gastroenterology & Urology · 83d
Cleared Feb 16, 1990
EXEL INDWELLING CATHETER
K895772 · FDZ
Exel Intl.
Gastroenterology & Urology · 143d
Cleared Feb 16, 1990
WILLIAMS PENILE ANESTHETIC RETAINER
K896160 · FHA
Cook Urological, Inc.
Gastroenterology & Urology · 115d
Cleared Feb 16, 1990
4 SURE UROLOGICAL CATHETER
K896725 · KOD
The Boston & Pacific Co., Inc.
Gastroenterology & Urology · 79d
Cleared Feb 16, 1990
DISPOSABLE URODYNAMIC CATHETER SET
K896784 · KOD
Life-Tech Intl., Inc.
Gastroenterology & Urology · 74d
Cleared Feb 15, 1990
GOOSEN URINARY DRAINAGE SYSTEM
K896579 · KNX
Goosen Enterprises, Inc.
Gastroenterology & Urology · 87d
Cleared Feb 15, 1990
SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC
K900439 · FIH
L H M Ent., Inc.
Gastroenterology & Urology · 17d
Cleared Feb 14, 1990
PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.
K896680 · FED
Interson Corp.
Gastroenterology & Urology · 79d
Cleared Feb 12, 1990
MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.
K895244 · KOC
National Medical Care, Medical...
Gastroenterology & Urology · 175d
Cleared Feb 12, 1990
BUZZY BEAR ENURESIS ALARM
K895852 · KPN
Med-Design, Inc.
Gastroenterology & Urology · 132d
Cleared Feb 12, 1990
ALL SILICONE FOLEY CATHETER
K896053 · KOD
Rochester Medical Corp.
Gastroenterology & Urology · 117d
Cleared Feb 12, 1990
DOBBHOFF(R) PAPILLOTOME
K896612 · KNS
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 83d
Cleared Feb 12, 1990
BITE BLOCK
K896691 · MNK
Endoscopix
Gastroenterology & Urology · 76d