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

4681–4704 of 9,870

Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology

Cleared Oct 28, 1998

MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER

Mri Manufacturing and Research, Inc.

Gastroenterology & Urology · 64d

Cleared Oct 26, 1998

ADVANCED UROSCIENCE INJECTION NEEDLE

Advanced Uroscience, Inc.

Gastroenterology & Urology · 70d

Cleared Oct 19, 1998

PERITRON PERINEOMETER MODEL 9300V OR 9300A

Cardio Design Pty. , Ltd.

Gastroenterology & Urology · 48d

Cleared Oct 16, 1998

Boston Scientific Corp

Gastroenterology & Urology · 88d

Cleared Oct 09, 1998

COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE

Novartis Nutrition Corp.

Gastroenterology & Urology · 179d

Cleared Oct 09, 1998

VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT

International Regulatory Consultants

Gastroenterology & Urology · 158d

Cleared Oct 09, 1998

MODIFICATION OF CRIT-LINE MONITOR III (CLM III)

In-Line Diagnostics Corp.

Gastroenterology & Urology · 88d

Cleared Oct 06, 1998

TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO

Transonic Systems, Inc.

Gastroenterology & Urology · 210d

Cleared Oct 05, 1998

MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE

Karl Storz Endoscopy

Gastroenterology & Urology · 48d

Cleared Sep 30, 1998

MEDIVISION CYSTOSCOPE

Medivision Scope Service Center, Inc.

Gastroenterology & Urology · 65d

Cleared Sep 23, 1998

GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H

Gambro Healthcare

Gastroenterology & Urology · 267d

Cleared Sep 23, 1998

MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT

Medical Device Technologies, Inc.

Gastroenterology & Urology · 30d

Cleared Sep 23, 1998

XENON LIGHT SOURCE, MODELS LS6180, LS6035

Contec Medical Vision, Ltd.

Gastroenterology & Urology · 30d

Cleared Sep 22, 1998

BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

Brennen Medical, Inc.

Gastroenterology & Urology · 74d

Cleared Sep 22, 1998

STRYKER URETERAL ILLUMINATOR SYSTEM III

Stryker Endoscopy

Gastroenterology & Urology · 63d

Cleared Sep 16, 1998

EUROMEDICAL HAEMATURIA FOLEY CATHETER

Unomedical Sdn Bhd

Gastroenterology & Urology · 394d

Cleared Sep 15, 1998

FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX

Fresenius USA, Inc.

Gastroenterology & Urology · 567d

Cleared Sep 14, 1998

FIBER OPTIC ENDOILLUMINATION PROBE

Microvision, Inc.

Gastroenterology & Urology · 61d

Cleared Sep 11, 1998

MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT

Ballard Medical Products

Gastroenterology & Urology · 25d

Cleared Sep 10, 1998

URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING

Gastroenterology & Urology · 154d

Cleared Sep 10, 1998

BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES

Bard Interventional Products Div.

Gastroenterology & Urology · 50d

Cleared Sep 09, 1998

LIGHT SABER BONE BIOPSY NEEDLE

Gastroenterology & Urology · 35d

Cleared Sep 08, 1998

ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002

Island Biosurgical, Inc.

Gastroenterology & Urology · 90d

Cleared Sep 08, 1998

PROSTATE BIOPSY NEEDLE

Remington Medical, Inc.

Gastroenterology & Urology · 60d