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NIPRO MEDICAL CORPORATION

Last updated September 17, 2026

Information

Country: US
Address: 3150 NW 107TH AVE, Doral, FL, 33172
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000132332
DUNS Number: —

Catalogue (464)

Page 8 of 10

Device	Model / Reference	Registries	Class	Status
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+76080	FDA UDI	Class II	Unknown
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+54080	FDA UDI	Class II	Unknown
Nipro Syringe	JD+03L2138	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Safety Fistula Needle	17GX1" HC-30W	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Safety Fistula Needle	15GX1-1/4" HC-30W	FDA UDI	Class II	Active
Nipro Biohole Needle With Capick Scab Remover	14GX1" HC-30W-D-CAP	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+05L2225-WEI	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+103080	FDA UDI	Class II	Unknown
Nipro Syringe	JD+03L2125	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+83080	FDA UDI	Class II	Unknown
Nipro Syringe	JD+03S2125-NIJ	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+30L-WEI	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+38150SR	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+162530TP	FDA UDI	Class II	Active
Slimline™ Blood Tubing Set With Transducer Protectors And Priming Set	A226Y/V813	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+44080	FDA UDI	Class II	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	A223Y/V809	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+92080	FDA UDI	Class II	Unknown
Nipro Safetouch™ Ii Safety Fistula Needle	15GX1" HTC-30R/TC-30B TWIN PACK	FDA UDI	Class II	Active
Nipro Syringe	JD+03S2219	FDA UDI	Class II	Active
Nipro Safelet Cath	CI+2420	FDA UDI	Class II	Active
Nipro Nitrile Powder Free Examination Gloves	GU-NITRILG-PF-US2K	FDA UDI	Class I	Active
Nipro Hypodermic Needle	AH+2613	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+66080	FDA UDI	Class II	Unknown
Nipro Syringe	JD+03L	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+163230TP	FDA UDI	Class II	Active
Nipro Syringe	JD+01T2516	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+35260AS	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+106045	FDA UDI	Class II	Unknown
Nipro Biohole Needle With Capick Scab Remover	15GX1" HC-40W-D-CAP	FDA UDI	Class II	Active
Nipro Latex Examination Gloves	GU-XLARGE-PF-1KUS	FDA UDI	Class I	Active
Nipro Safetouch™ Ii Safety Fistula Needle	14GX1	FDA UDI	Class II	Active
Nipro Nitrile Powder Free Examination Gloves	GU-NITRILEXS-PF-US	FDA UDI	Class I	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	A203/V801	FDA UDI	Class II	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	A217Y/V806	FDA UDI	Class II	Active
Nipro Nitrile Powder Free Examination Gloves	GU-NITRILELG-PF-US	FDA UDI	Class I	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+82080	FDA UDI	Class II	Unknown
Nipro Elisio™ -h Hemodialyzer	ELISIO™-21H	FDA UDI	Class II	Active
Nipro Nitrile Powder Free Examination Gloves	GU-NITRIXL-PF-US2K	FDA UDI	Class I	Active
NIPRO AQUALiner™	ALS+35150SS	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+38180SS	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+76045	FDA UDI	Class II	Unknown
NIPRO AQUALiner™	ALS+38150AR	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+84080	FDA UDI	Class II	Unknown
Nipro Safetouch™ Ii Safety Fistula Needle	16GX1" HTC-30W	FDA UDI	Class II	Active
Nipro Latex Examination Gloves	GU-XSMALL-PF-1KUS	FDA UDI	Class I	Active
Nipro Elisio™ -h Hemodialyzer	ELISIO™-19H	FDA UDI	Class II	Active
NIPRO AQUALiner™	ALS+38260SS	FDA UDI	Class II	Active
Nipro Elisio™ -m Hemodialyzer	ELISIO™-15M	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Gamma Safety Fistula Needle	18G X 1-1/4"	FDA UDI	Class II	Active

Related Companies

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 27, 2025	Z-0912-2026	—	open, classified	Screw may loosen or fallout of Hemodialysis system
Dec 19, 2017	Z-1876-2018	—	terminated	There is a possibility of the heparin line is occluded.
Aug 13, 2015	Z-0161-2016	—	terminated	Some 1 1/4" needles were packaged and labeled in the 1" blister package.
Mar 30, 2015	Z-0624-2016	—	terminated	Blood foaming was found during evaluation of the product.
Apr 1, 2014	Z-0599-2016	—	terminated	Device has the potential to have torn wings.
May 4, 2013	Z-1834-2014	—	terminated	There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.
Jul 27, 2012	Z-0135-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0134-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0136-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0137-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jul 27, 2012	Z-0138-2013	—	terminated	Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
Jan 13, 2010	Z-1103-2010	—	terminated	Nipro Medical Corporation, Miami FL is initiating a nationwide recall of all GlucoPro Insulin syringes (This does not include the GlucoPro syringe specific for use with the amigo Insulin pump). These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in