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
3817–3840 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 03, 2003
BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON
K022521 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 157d
Cleared Jan 03, 2003
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
K023358 · FGB
Acmi Corporation
Gastroenterology & Urology · 88d
Cleared Jan 02, 2003
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
K021994 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 198d
Cleared Dec 31, 2002
SOVIS OPTIQUE'S ENDOSCOPIC CABLE
K023633 · FFS
Sovis Optique
Gastroenterology & Urology · 63d
Cleared Dec 26, 2002
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
K023259 · FDF
Helix Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Dec 26, 2002
KEGELMASTER 2000
K023305 · HIR
Kegelmaster 2000 , Ltd.
Gastroenterology & Urology · 84d
Cleared Dec 23, 2002
LTFS230
K021775 · LNS
Healthtronics, Inc.
Gastroenterology & Urology · 208d
Cleared Dec 23, 2002
AIM-V (R) MEDIUM, MODEL 087-0112
K022086 · NDS
Invitrogen Corporation
Gastroenterology & Urology · 179d
Cleared Dec 23, 2002
DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
K022500 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 147d
Cleared Dec 23, 2002
DISPOSABLE ASPIRATION NEEDLE NA-200H
K023272 · FCG
The Olympus Optical Co.
Gastroenterology & Urology · 83d
Cleared Dec 20, 2002
MODIFICATION TO NANMA VACUUM PUMP
K013113 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 458d
Cleared Dec 20, 2002
GYNEFLEX
K021115 · HIR
Naissance Holdings, LC
Gastroenterology & Urology · 256d
Cleared Dec 20, 2002
FLEXIMA BILIARY CATHETER
K023870 · FGE
Boston Scientific/Medi-Tech
Gastroenterology & Urology · 30d
Cleared Dec 20, 2002
XTJF-160AF DUODENOVIDEOSCOPE
K024033 · FDT
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 14d
Cleared Dec 19, 2002
VIABIL BILIARY ENDOPROSTHESIS
K014215 · FGE
W.L. Gore & Associates, Inc.
Gastroenterology & Urology · 363d
Cleared Dec 19, 2002
SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND...
K024011 · NLU
Surgical Instruments Service and...
Gastroenterology & Urology · 15d
Cleared Dec 18, 2002
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA...
K023907 · KNQ
Cordis Corp.
Gastroenterology & Urology · 23d
Cleared Dec 13, 2002
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
K022905 · MSD
Horizon Medical Products, Inc.
Gastroenterology & Urology · 101d
Cleared Dec 13, 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY...
K023243 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 74d
Cleared Dec 12, 2002
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM
K013562 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 412d
Cleared Dec 11, 2002
NXSTAGE CARTRIDGE EXPRESS
K014152 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 358d
Cleared Dec 11, 2002
SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE
K023923 · KNW
Senorx, Inc.
Gastroenterology & Urology · 16d
Cleared Dec 10, 2002
VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
K023019 · FGI
Vomed Volzer Medizintechnik GmbH & Co.
Gastroenterology & Urology · 90d
Cleared Dec 04, 2002
TRANSONIC SYRINGE WARMER, MODEL SYR-1000
K022963 · MQS
Transonic Systems, Inc.
Gastroenterology & Urology · 89d