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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 5 of 10

Device	Model / Reference	Registries	Class	Status
Nipro Disposable Syringe	JD+01L-WEI	FDA UDI	Class II	Active
Nipro Syringe	JD+05L2125	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+10S	FDA UDI	Class II	Active
Nipro Safelet Cath	CI+1450	FDA UDI	Class II	Active
Nipro Syringe	JD+05L2238	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+03L2038-WEI	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+173230TP	FDA UDI	Class II	Active
Nipro Syringe	JD+03S2025-NIJ	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+103045	FDA UDI	Class II	Unknown
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+72045	FDA UDI	Class II	Unknown
Nipro Syringe	JD+05L2225	FDA UDI	Class II	Active
Nipro Hypodermic Needle	AH+1925	FDA UDI	Class II	Active
NIPRO SafeTouch™ Safety Scalp Vein Set	SPR+19G19	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+46045	FDA UDI	Class II	Unknown
Nipro Syringe	JD+01L	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+94080	FDA UDI	Class II	Unknown
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+94080	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+73080	FDA UDI	Class II	Active
Nipro Solution Infusion Set	IS-01-A/A-21G/BL	FDA UDI	Class II	Active
Nipro Syringe	JD+03S2516	FDA UDI	Class II	Active
Nipro Syringe	JD+03L-NIJ	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+83045	FDA UDI	Class II	Unknown
Nipro Ultrafilter	CF+609N	FDA UDI	Class II	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	A211/V804	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+46080	FDA UDI	Class II	Active
NIPRO Cellentia™-H Hemodialyzer	Cellentia™-17H	FDA UDI	Class II	Active
Cronus HP - High Pressure Peripheral Balloon Catheter	NHP+92080	FDA UDI	Class II	Active
Nipro Safelet Cath	CI+1832	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+73045	FDA UDI	Class II	Unknown
Nipro Disposable Syringe	JD+03L2138-WEI	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+03L2325-WEI	FDA UDI	Class II	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	A210/V803	FDA UDI	Class II	Active
Nipro SafeTouch IV Catheter	NI-CSF2425PET	FDA UDI	Class II	Active
Nipro SafeTouch IV Catheter	NI-CSF1832PET	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+10L2225	FDA UDI	Class II	Active
Nipro Disposable Syringe	JD+03L2219-WEI	FDA UDI	Class II	Active
Nipro Set Blood Tubing Set With Transducer Protectors And Priming Set	A204/V801	FDA UDI	Class II	Active
Nipro Syringe	JD+03L2525	FDA UDI	Class II	Active
Nipro SafeTouch IV Catheter	NI-CSF2225PET	FDA UDI	Class II	Active
Nipro SafeTouch TULIP Safety Fistula Needle	FT+163230BC	FDA UDI	Class II	Active
Nipro Safelet Cath	CI+2225	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+64080	FDA UDI	Class II	Unknown
Nipro Hypodermic Needle	AH+2125	FDA UDI	Class II	Active
Nipro Safetouch™ Ii Safety Fistula Needle	16GX1" HC-30R/C-30B TWIN PACK	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+62080	FDA UDI	Class II	Unknown
Nipro Disposable Syringe	JD+10L2038	FDA UDI	Class II	Active
Cronus HP PTA Balloon Catheter	NHP+66080	FDA UDI	Class II	Active
NIPRO Cellentia™-H Hemodialyzer	Cellentia™-21H	FDA UDI	Class II	Active
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+42080	FDA UDI	Class II	Unknown
Cronus™ HP - OTW PTA BALLOON CATHETER	NCH+72080	FDA UDI	Class II	Unknown

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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