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
6889–6912 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 07, 1990
MULTI-STRIP
K901228 · FKX
Bellhouse Medical, Inc.
Gastroenterology & Urology · 54d
Cleared May 04, 1990
FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM
K896288 · FFT
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 186d
Cleared May 04, 1990
DACOMED NEGATIVE PRESSURE ERECTION DEVICE
K900774 · LKY
Dacomed Corp.
Gastroenterology & Urology · 73d
Cleared May 04, 1990
VACUUM ERECTION DEVICE (VED)
K901223 · LKY
Mission Pharmacal Co.
Gastroenterology & Urology · 51d
Cleared May 04, 1990
STAYEREC SYSTEM(TM)
K901318 · LKY
Osbon Medical Systems, Ltd.
Gastroenterology & Urology · 44d
Cleared May 04, 1990
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
K901603 · KOB
Bivona Medical Technologies
Gastroenterology & Urology · 38d
Cleared May 03, 1990
DANTEC MENUET
K896575 · FAP
Dantec Medical, Inc.
Gastroenterology & Urology · 164d
Cleared May 02, 1990
FRENTA(R) DUO-SET
K895246 · KNT
Delmed, Inc.
Gastroenterology & Urology · 254d
Cleared May 02, 1990
600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA
K895330 · KNT
Delmed, Inc.
Gastroenterology & Urology · 244d
Cleared May 02, 1990
ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE
K895366 · KNT
Fresenius USA, Inc.
Gastroenterology & Urology · 247d
Cleared May 02, 1990
ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU
K895696 · KNT
Delmed, Inc.
Gastroenterology & Urology · 223d
Cleared May 02, 1990
ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III
K895919 · KNT
Delmed, Inc.
Gastroenterology & Urology · 204d
Cleared May 02, 1990
ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III
K895933 · KNT
Delmed, Inc.
Gastroenterology & Urology · 204d
Cleared May 02, 1990
URINE COLLECTOR LEG BAG
K896688 · KNX
Medline Industries, Inc.
Gastroenterology & Urology · 155d
Cleared May 02, 1990
DYNA-FLO URINARY DRAINAGE BAG
K896695 · EYZ
Medline Industries, Inc.
Gastroenterology & Urology · 155d
Cleared May 02, 1990
RESPONSE EXTERNAL PENILE RIGIDITY DEVICE
K900559 · LKY
Smith-Collins Pharmaceutical, Inc.
Gastroenterology & Urology · 84d
Cleared May 02, 1990
MAGNET RETRIEVAL CATHETER
K900852 · KNT
Cook, Inc.
Gastroenterology & Urology · 69d
Cleared Apr 26, 1990
TELEMETRY POWER PACK MODEL 2
K891927 · FCP
Lucas & Rhea Mfg.
Gastroenterology & Urology · 394d
Cleared Apr 25, 1990
PHYCON ALL SILICONE BALLOON CATHETER
K894883 · EZL
Vitaid, Ltd.
Gastroenterology & Urology · 267d
Cleared Apr 25, 1990
SAFE AID DEVICE IMPOTENCE DEVICE
K896357 · LKY
Dr. John P. March
Gastroenterology & Urology · 170d
Cleared Apr 25, 1990
HAEMOTRONIC BLOOD LINE SET
K896407 · FJK
Healthcare Suppliers, Inc.
Gastroenterology & Urology · 169d
Cleared Apr 25, 1990
WORKING CHANNEL VALVE
K900781 · FFY
Applied Urology, Inc.
Gastroenterology & Urology · 64d
Cleared Apr 25, 1990
DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S
K900803 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 64d
Cleared Apr 20, 1990
HEMODIALYSIS BLOOD LINES
K900306 · KOC
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 89d