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
5929–5952 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 02, 1994
MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT
K921652 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 756d
Cleared May 02, 1994
VYGON - ENTERAL FEEDING TUBE - POLYURETHANE
K925854 · KNT
Vygon Corp.
Gastroenterology & Urology · 531d
Cleared May 02, 1994
GABRIEL URETERAL ILLUMINATOR SYSTEM
K940019 · FCS
Gabriel Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Apr 28, 1994
CADD-TPN(TM) AMBULATORY INFUSION SYSTEM
K931113 · FIH
Pharmacia Deltec, Inc.
Gastroenterology & Urology · 420d
Cleared Apr 28, 1994
BIP MULTI MODIFICATION
K934371 · KNW
Bip USA, Inc.
Gastroenterology & Urology · 233d
Cleared Apr 28, 1994
VECTOR AMBULATORY DRUG DELIVERY SYSTEM
K935461 · FIH
Infusion Technology Intl.
Gastroenterology & Urology · 167d
Cleared Apr 22, 1994
KARL STORZ XENON LIGHT SOURCE MODEL 201320-20
K934559 · GCT
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 218d
Cleared Apr 21, 1994
MILLEX, DUALEX (PLUS, ULTRA)
K934069 · FIB
Millipore Corp.
Gastroenterology & Urology · 244d
Cleared Apr 21, 1994
ENDOSCOPIC ARTICULATING MULTI-FEED STAPLER WITH RELOAD UNIT
K935756 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 146d
Cleared Apr 20, 1994
FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM
K921456 · FKP
Fresenius USA, Inc.
Gastroenterology & Urology · 754d
Cleared Apr 20, 1994
LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
K940270 · GCT
Welch Allyn, Inc.
Gastroenterology & Urology · 89d
Cleared Apr 19, 1994
COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
K934266 · EXJ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 231d
Cleared Apr 19, 1994
BIOPSY NEEDLE AND HOUSING
K941549 · KNW
Biopsys Medical, Inc.
Gastroenterology & Urology · 20d
Cleared Apr 18, 1994
UROGRAM CYSTOMETROGRAM
K936041 · FEN
Myo/Kinetic Systems, Inc.
Gastroenterology & Urology · 119d
Cleared Apr 18, 1994
NAMIC ARIA(TM) INFLATION DEVICE
K940542 · EZN
American Medical Systems, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 18, 1994
ACUCISE GUIDEWIRE EXCHANGE SHEATH
K941010 · EYB
Applied Medical Resources
Gastroenterology & Urology · 46d
Cleared Apr 18, 1994
LOW PRESSURE TAMPONADE BALLOON CATHETER
K941012 · EYB
Applied Medical Resources
Gastroenterology & Urology · 46d
Cleared Apr 15, 1994
SILICONE FOLEY CATHETER
K930344 · EZL
Cook Urological, Inc.
Gastroenterology & Urology · 445d
Cleared Apr 15, 1994
RIWOLITH 2280 PROBES
K931755 · FFK
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 372d
Cleared Apr 14, 1994
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
K922527 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 686d
Cleared Apr 11, 1994
CURITY FAST-CATH FEMALE CATHETER KIT
K935774 · EYT
Kendall Healthcare Products Co....
Gastroenterology & Urology · 129d
Cleared Apr 08, 1994
ENCOMPAS COMFORT BLOCK # 0B-10
K933537 · MNK
Encompas Unlimited, Inc.
Gastroenterology & Urology · 261d
Cleared Apr 08, 1994
LIQUID LIGHT 500
K940962 · FFS
Incredivision, Inc.
Gastroenterology & Urology · 37d
Cleared Apr 08, 1994
XENON LIGHT SOURCE
K940963 · FFS
Incredivision, Inc.
Gastroenterology & Urology · 37d