FDA Registered Urology Medical Devices List: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

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Medical Specialty: Urology
Classification: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

	Common Generic Device Name	Proprietary Device Name	Company
1	ALL SILICONE FOLEY BALLOON CATHETER WITH AND WITH OUT TEMPERATURE SENSOR	3T/SEWOON SILICONE FOLEY BALLOON CATHETERS	SEWOON MEDICAL CO., LTD. 344-14, DORIM-RI, IPJANG-MYEON 344-14, DORIM-RI, IPJANG-MYEON SEOUL, KS 82-41-58429036 / 303-838-2407
2	ANTIBACTERIAL FOLEY CATHETER	ANTIBACTERIAL FOLEY CATHETER	ROCHESTER MEDICAL CORP. ONE ROCHESTER MEDICAL DR. STEWARTVILLE, MN 55976 US 507-533-9600 / 507-533-9600
3	VARIOUS	BARDEX I.C.	PRODUCTOS PARA EL CUIDADO DE LA SALUD KM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA, MX 908-277-8000 / 908-277-8513
4	VARIOUS	BARDEX I.C.	C.R. BARD, INC. 428 POWERHOUSE RD. MONCKS CORNER, SC 29461 US 908-277-8000 / 908-277-8513
5	ANTIMICROBIAL FOLEY CATHETER, TEMP-SENSING SILVER-HYDROGEL	BARDEX IC	C.R. BARD, INC. 1211 MARY MAGNAN BLVD. MADISON, GA 30650 US 908-277-8000 / 908-277-8513

The following companies have received SBIR/SBTT awards that may be related to these products. Click on the listings below for more details.

Grant# R44HL067473-02A2
ACCUMED SYSTEMS, INC.

Grant# R43DK065319-01
CCL BIOMEDICAL, INC.

Grant# R43NS050011-01
CFD RESEARCH CORPORATION

Grant# R44HL063535-03
E.P., LTD

Grant# R44HL064434-03
EKOS CORPORATION

Grant# R43DK061823-01A2
FLUENT CARDIOVASCULAR SOLUTIONS, INC.

Grant# R44HL067487-02
FOSTER-MILLER TECHNOLOGIES, INC.

Grant# R44HL067487-03
FOSTER-MILLER TECHNOLOGIES, INC.

Grant# R43HL072639-01
LEXMED TECHNOLOGIES, INC.

Grant# R43HL076003-01
MAXWELL SENSORS, INC.

Grant# R44HL070368-02A1
MILLAR INSTRUMENTS, INC.

Grant# R43HD047436-01
ORIGEN BIOMEDICAL, INC.

Grant# R41HD047495-01
SHAPE CHANGE TECHNOLOGIES, LLC

Grant# R43NS048695-02
THERATAXIS, LLC

Grant# R41CA110145-01
VIARES TECHNOLOGIES, INC.

Grant# R44DK057918-03
WHALEN BIOMEDICAL, INC.

Grant# R44DK057918-02
WHALEN BIOMEDICAL, INC.